Rezum Pilot: Rezum I Pilot Study for Benign Prostatic Hyperplasia

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02943070
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Arm: 1
• Duration (Months): 81
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Evaluate the safety and efficacy of the Rezum System for the treatment of BPH

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia; Benign Prostatic Hyperplasia; Adenoma, Prostatic; Prostatic Adenoma; Prostatic Hyperplasia, Benign; Prostatic Hypertrophy; Prostatic Hypertrophy, Benign; Rezum	Device: Rezum System	N/A

Detailed Description

Prospective, non-randomized clinical trial of subjects with benign prostatic hyperplasia. The objective of the study are to 1) determine the safety and efficacy of the BPH Rezum System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH), and 2) further document the safety and post-operative effects of the Rezum System in the treatment of obstructive BPH.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Rezum Treatment Patients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.

Device: Rezum System; The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.; Other Names: Rezum Procedure Rezum Water Vapor Ablation Rezum Delivery Device Rezum Generator

Outcome Measures

Primary Outcome Measures

1. International Prostate Symptom Score (IPSS) Change From Baseline [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

   International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change (improvement) in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.

2. Major Complications [3 months]

   Safety assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure). The device related complications that will be compared for this safety endpoint are: Severe Urinary Retention (Retention ≥ 24 hours) Fistula between rectum and urethra Perforation of the rectum or GI tract New incidences of retrograde ejaculation

Secondary Outcome Measures

1. Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

   The proportion of study subjects who were responders were evaluated. A responder is defined as a subject with ≥ 30% improvement in BPH symptoms from baseline as measured by the IPSS.

2. Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

   The proportion of study subjects who were responders were evaluated. For this measure a responder is defined as a subject with ≥ 50% improvement in BPH symptoms from baseline as measured by the IPSS.

3. Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

   Analysis will be provided for proportion of subjects with improvement ≥ 8 points from baseline at 1 week, 1 month, and 3 months, 6 months, 1 year, annually to 5 years

4. Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax) [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

   Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. Average results are based on age and sex. Typical uroflow rates ranges from 10 ml to 21 ml per second. An increase in mL/sec corresponds to improved urinary function.

5. Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

   Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥ 30% improvement from baseline at each follow-up interval.

6. Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

   Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥3 mL/sec improvement from baseline at each follow-up interval.

7. Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

   Change in post void residual (PVR) urine volume in ml. Post void residual volume was measured by either ultrasound to measure the volume left in the bladder after urination, or by inserting a urinary catheter into the bladder after urination to drain and measure residual urine. Either measurement tool was allowed but the same measurement was to be used pre and post treatment.

8. Change in Sexual Function - Erectile Function [1 month, 3 months, 6 months, 1 year, annually to 5 years]

   Change from baseline in sexual function was measured by the International Index of Erectile Function (IIEF) (Scoring on the IIEF ranges from 1 to 30. An increase in score indicates improvement from baseline)

9. Change in Sexual Function - Retrograde Ejaculation [1 Week post procedure, 1 Month post procedure, 3 Months post procedure]

   Rate of Retrograde Ejaculation (when no fluid exits the penis during orgasm (e.g., dry orgasm)

10. International Prostate Symptom Score (IPSS) Assessment by Prostate Volume [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

    International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score.

11. International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

    International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score. Results report change in IPSS by follow up interval for subjects treated in both lateral lobes and median lobe vs. subjects treated in lateral lobes alone.

12. International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years]

    International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval and grouped by Baseline IPSS. Improvement in symptoms is shown by a reduction in score.

13. Procedural Pain Score [Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure]

    Pain scores were obtained for all subjects using the Iowa Pain Thermometer. Maximum intraprocedural pain scores were analyzed, together with the pain scores reported at follow-up intervals through 3 months. The treatment pain scores were reported by subjects post-procedure and was based on their recollections. Scale is 0-12 with higher scores corresponding to higher pain reported.

14. Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS) [Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years]

    Change in Quality of Life was measured using a QoL question in the IPSS. QoL data were collected at each follow up visit. One question in the IPSS asked subjects to rate their "quality of life due to urinary symptoms" on a scale of 0 = Delighted to 6 = Terrible. A reduction in score from baseline equates to improved outcome.

15. Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII) [Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years]

    Change in Quality of Life will be measured with the Benign Prostatic Hyperplasia Impact Index (BPHII). Data were collected at specified follow up visits. BPHII scores range from 0 (no/mild symptoms) to 35 (severe symptoms). A reduction in score from baseline equates to an improvement in symptoms.

16. Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L [1 month, 3 months, 6 months, 1 year, then annually to 5 years]

    Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. EQ-5D-3L index ranges from -0.109 to 1.000, with 1.000 corresponding to the best health state and -0.109 corresponding to the worst health. Mean change in overall score from baseline is reported.

17. Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS) [1 month, 3 months, 6 months, 1 year, then annually to 5 years]

    Quality of Life was measured using EQ-5D-3L questionnaire and collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. The EQ-5D-3L includes a visual analog scale (VAS) which is a vertical scale with numbers ranging from 0 to 100. Subjects were asked to draw a line to the place on the scale that best represented how good or bad his health was on that day. The worst state a subject can imagine is marked zero, and the best state the subject can imagine is marked 100. Mean change in VAS score from baseline is reported. An increase in score is considered a better outcome.

18. Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L [1 month, 3 months, 6 months, 1 year, then annually to 5 years]

    Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. Each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Presented below are the scoring counts for each of the dimensions for baseline and follow up interval.

19. Subject Satisfaction - Satisfied With Overall Procedure [1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years]

    Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. These will be measured as: • Proportion of subjects that are satisfied with the procedure overall Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

20. Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family [1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years]

    Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects that would recommend this treatment to friends and families Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

21. Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years [1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years]

    Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects who would undergo the same treatment if their symptoms were to recur after 5 years Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.

22. Procedural Parameters - Procedure Time [Day of Procedure]

    Procedure time: Time from delivery device insertion to final delivery device withdrawal

23. Procedural Parameters - Treatment Time [Day of Procedure]

    Treatment time: time from first vapor delivery to last vapor delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.

2. IPSS score of ≥ 15.

3. Qmax: Peak flow rate ≤ 15 ml/sec.

4. Post-void residual (PVR) < 300 ml.

5. Prostate transverse diameter > 30 mm.

6. Prostate volume between 20 to 120 gm.

7. Voided volume ≥ 125 mL

8. Subject able to complete the study protocol in the opinion of the investigator.

9. Life expectancy of at least one year.

Exclusion Criteria:

1. History of any illness or surgery that may confound the results of the study or have risk to subject.

2. Presence of a penile implant.

3. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH.

4. Currently enrolled or has been enrolled in another trial in the past 30 days.

5. Confirmed or suspected malignancy of prostate or bladder

6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.

7. Previous pelvic irradiation or radical pelvic surgery.

8. Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catherization specimen)

9. Neurogenic bladder or sphincter abnormalities.

10. Urethral strictures, bladder neck contracture or muscle spasms.

11. Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an exclusion criteria.)

12. Subjects interested in maintaining fertility.

13. Use of concomitant medications to include the following:

14. Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes).

15. Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.

16. Use of 5-alpha reductase inhibitor within the last 6 months

17. Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing

18. Subject is unable or unwilling to go through the "washout" period prior to treatment.

19. Subject has chronic urinary retention.

20. Post-void residual volume > 300 ml.

21. Significant urge incontinence.

22. Poor detrusor muscle function.

23. Neurological disorders which might affect bladder or sphincter function.

24. Urinary sphincter abnormalities.

25. Bladder stones.

26. Evidence of bacterial prostatitis or symptoms of epididymitis

27. Renal impairment or serum creatinine > 2.0 mg/dl

28. In the physician's opinion, subject cannot tolerate a cystoscopy procedure well.

29. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.

30. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study.

31. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).

32. Biopsy of prostate within 30 days of procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Brno		Czechia
2	Clinica Canela	La Romana		Dominican Republic
3	Urologcentrum	Stockholm		Sweden

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Kevin M Hagelin, Program Manager, Clinical Affairs, Boston Scientific

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02943070
• Other Study ID Numbers: 1189-001
• First Posted: Oct 24, 2016
• Last Update Posted: Mar 16, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Boston Scientific Corporation: Rezum; Water Vapor Ablation
• Additional relevant MeSH terms: Adenoma; Prostatic Hyperplasia; Hyperplasia; Hypertrophy

Study Results

Participant Flow

Recruitment Details

This prospective, international, multicenter, non-randomized study recruited subjects who met inclusion/exclusion criteria and consented to participate. Subjects on BPH medication underwent a washout period prior to treatment. Subjects who successfully completed the washout period and still met the inclusion/exclusion criteria were enrolled in the study. Subjects were considered officially enrolled only if treatment with the NxThera Rezūm System was attempted.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Period Title: Overall Study
STARTED	50
COMPLETED	7
NOT COMPLETED	43

Baseline Characteristics

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.5 (7.1)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	50 100%
Race/Ethnicity, Customized (Count of Participants)
Black or African Origin	2 4%
Caucasian	45 90%
Hispanic or Latino	3 6%
Region of Enrollment (participants) [Number]
Sweden	27 54%
Czechia	18 36%
Dominican Republic	5 10%

Outcome Measures

1. Primary Outcome

Title	International Prostate Symptom Score (IPSS) Change From Baseline
Description	International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change (improvement) in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Mean change (improvement) in score was calculated for the number of subjects providing data at each follow-up visit.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
IPSS Change at 1 Week	-0.4 (7.8)
IPSS Change at 1 Month	-5.0 (8.3)
IPSS Change at 3 Months	-13.1 (7.2)
IPSS Change at 6 Months	-12.6 (7.9)
IPSS Change at 12 Months	-12.2 (7.7)
IPSS Change at 24 Months	-11.7 (8.4)
IPSS Change at 36 Months	-9.4 (9.0)
IPSS Change at 48 Months	-9.6 (7.5)
IPSS Change at 60 Months	-8.4 (6.7)

2. Primary Outcome

Title	Major Complications
Description	Safety assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure). The device related complications that will be compared for this safety endpoint are: Severe Urinary Retention (Retention ≥ 24 hours) Fistula between rectum and urethra Perforation of the rectum or GI tract New incidences of retrograde ejaculation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Incidence of device-related complications pre-specified under this safety endpoint assessed through 3 months post-implant.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Severe urinary retention (retention >=24 hours	1
Fistula between rectum and urethra	0
Perforation of the Rectum or GI Tract	0
New incidences of retrograde ejaculation	0

3. Secondary Outcome

Title	Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement
Description	The proportion of study subjects who were responders were evaluated. A responder is defined as a subject with ≥ 30% improvement in BPH symptoms from baseline as measured by the IPSS.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and at the follow-up visit are included in the data summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Proportion of Responders with>=30% Improvement at 1 Week	12 24%
Proportion of Responders with>=30% Improvement at 1 Month	20 40%
Proportion of Responders with>=30% Improvement at 3 Months	39 78%
Proportion of Responders with>=30% Improvement at 6 Months	40 80%
Proportion of Responders with>=30% Improvement at 12 Months	36 72%
Proportion of Responders with>=30% Improvement at 24 Months	28 56%
Proportion of Responders with>=30% Improvement at 36 Months	19 38%
Proportion of Responders with>=30% Improvement at 48 Months	18 36%
Proportion of Responders with>=30% Improvement at 60 Months	4 8%

4. Secondary Outcome

Title	Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement
Description	The proportion of study subjects who were responders were evaluated. For this measure a responder is defined as a subject with ≥ 50% improvement in BPH symptoms from baseline as measured by the IPSS.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visits are included in the data summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Proportion of Responders with a ≥ 50% IPSS Improvement at 1 Week	3 6%
Proportion of Responders with a ≥ 50% IPSS Improvement at 1 Month	14 28%
Proportion of Responders with a ≥ 50% IPSS Improvement at 3 Months	35 70%
Proportion of Responders with a ≥ 50% IPSS Improvement at 6 Months	35 70%
Proportion of Responders with a ≥ 50% IPSS Improvement at 12 Months	30 60%
Proportion of Responders with a ≥ 50% IPSS Improvement at 24 Months	20 40%
Proportion of Responders with a ≥ 50% IPSS Improvement at 36 Months	15 30%
Proportion of Responders with a ≥ 50% IPSS Improvement at 48 Months	13 26%
Proportion of Responders with a ≥ 50% IPSS Improvement at 60 Months	2 4%

5. Secondary Outcome

Title	Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS
Description	Analysis will be provided for proportion of subjects with improvement ≥ 8 points from baseline at 1 week, 1 month, and 3 months, 6 months, 1 year, annually to 5 years
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Proportion of Responders With Improvement ≥ 8 Points in IPSS at 1 Week	9 18%
Proportion of Responders With Improvement ≥ 8 Points in IPSS at 1 Month	18 36%
Proportion of Responders With Improvement ≥ 8 Points in IPSS at 3 Months	37 74%
Proportion of Responders With Improvement ≥ 8 Points in IPSS at 6 Months	37 74%
Proportion of Responders With Improvement ≥ 8 Points in IPSS at 12 Months	33 66%
Proportion of Responders With Improvement ≥ 8 Points in IPSS at 24 Months	24 48%
Proportion of Responders With Improvement ≥ 8 Points in IPSS at 36 Months	17 34%
Proportion of Responders With Improvement ≥ 8 Points in IPSS at 48 Months	16 32%
Proportion of Responders With Improvement ≥ 8 Points in IPSS at 60 Months	4 8%

6. Secondary Outcome

Title	Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)
Description	Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. Average results are based on age and sex. Typical uroflow rates ranges from 10 ml to 21 ml per second. An increase in mL/sec corresponds to improved urinary function.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Mean change in urinary flow rate was calculated for subjects with data at baseline and follow-up visit.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Change from baseline in peak urinary flow rate (Qmax) at 1 Week	-0.2 (4.3)
Change from baseline in peak urinary flow rate (Qmax) at 1 Month	1.9 (4.8)
Change from baseline in peak urinary flow rate (Qmax) at 3 Months	5.5 (6.6)
Change from baseline in peak urinary flow rate (Qmax) at 6 Months	5.2 (5.7)
Change from baseline in peak urinary flow rate (Qmax) at 12 Months	4.7 (7.0)
Change from baseline in peak urinary flow rate (Qmax) at 24 Months	4.1 (6.7)
Change from baseline in peak urinary flow rate (Qmax) at 36 Months	3.5 (6.2)
Change from baseline in peak urinary flow rate (Qmax) at 48 months	3.0 (4.3)
Change from baseline in peak urinary flow rate (Qmax) at 60 Months	3.9 (4.3)

7. Secondary Outcome

Title	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline
Description	Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥ 30% improvement from baseline at each follow-up interval.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Measure calculated for subjects with data at baseline and follow-up visit.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Qmax improvement of 30% or more over baseline at 1 Week	14 28%
Qmax improvement of 30% or more over baseline at 1 Month	21 42%
Qmax improvement of 30% or more over baseline at 3 Months	28 56%
Qmax improvement of 30% or more over baseline at 6 Months	32 64%
Qmax improvement of 30% or more over baseline at 12 Months	30 60%
Qmax improvement of 30% or more over baseline at 24 Months	20 40%
Qmax improvement of 30% or more over baseline at 36 Months	13 26%
Qmax improvement of 30% or more over baseline at 48 months	4 8%
Qmax improvement of 30% or more over baseline at 60 Months	4 8%

8. Secondary Outcome

Title	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec
Description	Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥3 mL/sec improvement from baseline at each follow-up interval.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Measure calculated for subjects with data at baseline and follow-up visit.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Subjects with Qmax Improvement of ≥ 3 ml/sec at 1 Week	11 22%
Subjects with Qmax Improvement of ≥ 3 ml/sec at 1 Month	19 38%
Subjects with Qmax Improvement of ≥ 3 ml/sec at 3 Months	30 60%
Subjects with Qmax Improvement of ≥ 3 ml/sec at 6 Months	30 60%
Subjects with Qmax Improvement of ≥ 3 ml/sec at 12 Months	27 54%
Subjects with Qmax Improvement of ≥ 3 ml/sec at 24 Months	18 36%
Subjects with Qmax Improvement of ≥ 3 ml/sec at 36 Months	12 24%
Subjects with Qmax Improvement of ≥ 3 ml/sec at 48 months	3 6%
Subjects with Qmax Improvement of ≥ 3 ml/sec at 60 Months	3 6%

9. Secondary Outcome

Title	Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval
Description	Change in post void residual (PVR) urine volume in ml. Post void residual volume was measured by either ultrasound to measure the volume left in the bladder after urination, or by inserting a urinary catheter into the bladder after urination to drain and measure residual urine. Either measurement tool was allowed but the same measurement was to be used pre and post treatment.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Measure calculated for subjects with data at baseline and follow-up visit.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Change from baseline in PVR at 1 Week	48.8 (135.9)
Change from baseline in PVR at 1 Month	-20.2 (94.7)
Change from baseline in PVR at 3 Months	-30.5 (72.4)
Change from baseline in PVR at 6 Months	-27.1 (81.6)
Change from baseline in PVR at 12 Months	-22.8 (83.7)
Change from baseline in PVR at 24 Months	-11.8 (102.2)
Change from baseline in PVR at 36 Months	11.9 (134.4)
Change from baseline in PVR at 48 months	-14.3 (54.5)
Change from baseline in PVR at 60 Months	-12.6 (52.4)

10. Secondary Outcome

Title	Change in Sexual Function - Erectile Function
Description	Change from baseline in sexual function was measured by the International Index of Erectile Function (IIEF) (Scoring on the IIEF ranges from 1 to 30. An increase in score indicates improvement from baseline)
Time Frame	1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Mean change in total score was calculated for subjects providing data at each follow-up visit.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
IEFF change from baseline at 1 Month	-4.2 (20.7)
IEFF change from baseline at 3 Months	3.3 (20.0)
IEFF change from baseline at 6 Months	6.3 (17.6)
IEFF change from baseline at 12 Months	5.8 (16.4)
IEFF change from baseline at 24 Months	8.2 (14.8)
IEFF change from baseline at 36 Months	10.7 (16.9)
IEFF change from baseline at 48 Months	2.7 (27.4)
IEFF change from baseline at 60 Months	12.5 (24.1)

11. Secondary Outcome

Title	Change in Sexual Function - Retrograde Ejaculation
Description	Rate of Retrograde Ejaculation (when no fluid exits the penis during orgasm (e.g., dry orgasm)
Time Frame	1 Week post procedure, 1 Month post procedure, 3 Months post procedure

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Incidence of retrograde ejaculation at 1 Week	0 0%
Incidence of retrograde ejaculation at 1 Month	0 0%
Incidence of retrograde ejaculation at 3 Months	0 0%

12. Secondary Outcome

Title	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume
Description	International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Measure calculated for subjects providing data at each follow-up visit.

Arm/Group Title	Rezum Treatment - Larger Prostates (≥35gm)	Rezum Treatment - Smaller Prostates (<35g)
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	37	13
IPSS Change at 1 Week	0.3 (7.2)	-2.4 (9.3)
IPSS Change at 1 Month	-3.4 (8.0)	-9.4 (7.8)
IPSS Change at 3 Months	-12.0 (6.6)	-15.9 (8.3)
IPSS Change at 6 Months	-11.8 (7.1)	-14.9 (9.7)
IPSS Change at 12 Months	-11.6 (7.7)	-13.7 (8.0)
IPSS Change at 24 Months	-10.2 (8.4)	-16.1 (7.4)
IPSS Change at 36 Months	-9.2 (9.3)	10.0 (8.8)
IPSS Change at 48 Months	-9.6 (8.4)	-9.5 (4.0)
IPSS Change at 60 Months	-6.0 (5.6)	-14.5 (6.4)

13. Secondary Outcome

Title	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe
Description	International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score. Results report change in IPSS by follow up interval for subjects treated in both lateral lobes and median lobe vs. subjects treated in lateral lobes alone.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment - No Median Lobe Present (Lateral Lobes Treated)	Rezum Treatment - Median Lobe Present (Lateral and Median Lobes Treated)
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	37	13
IPSS Change at 1 Week	0.4 (7.6)	-2.5 (8.2)
IPSS Change at 1 Month	-4.1 (7.0)	-7.4 (11.2)
IPSS Change at 3 Months	-11.9 (6.7)	-17.0 (7.8)
IPSS Change at 6 Months	-12.2 (7.5)	-14.3 (9.2)
IPSS Change at 12 Months	-11.9 (7.5)	-13.1 (8.7)
IPSS Change at 24 Months	11.7 (7.7)	-11.8 (10.9)
IPSS Change at 36 Months	-9.4 (8.9)	-9.2 (10.2)
IPSS Change at 48 Months	-10.5 (7.4)	-5.6 (7.5)
IPSS Change at 60 Months	-8.2 (7.3)	-10.0 (0.0)

14. Secondary Outcome

Title	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS
Description	International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval and grouped by Baseline IPSS. Improvement in symptoms is shown by a reduction in score.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Subjects With Baseline IPSS 13-19	Subjects With Baseline IPSS 20-25	Subjects With Baseline IPSS 26-35
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	23	20	7
IPSS Change at 1 Week	1.8 (4.9)	-2.9 (9.1)	-0.1 (10.2)
IPSS Change at 1 Month	-3.3 (7.0)	-5.4 (8.7)	-9.0 (10.6)
IPSS Change at 3 Months	-9.7 (5.4)	-13.9 (7.1)	-21.4 (5.5)
IPSS Change at 6 Months	-9.2 (5.8)	-14.1 (7.7)	-19.7 (8.9)
IPSS Change at 12 Months	-8.2 (5.0)	-14.6 (7.6)	-19.2 (9.2)
IPSS Change at 24 Months	-7.9 (5.2)	-12.9 (8.9)	-20.6 (9.2)
IPSS Change at 36 Months	-6.9 (5.2)	-9.0 (10.9)	-20.7 (4.0)
IPSS Change at 48 Months	-7.2 (5.2)	-9.8 (8.3)	-17.7 (8.0)
IPSS Change at 60 Months	-7.7 (4.7)	-3.5 (7.8)	-14.5 (6.4)

15. Secondary Outcome

Title	Procedural Pain Score
Description	Pain scores were obtained for all subjects using the Iowa Pain Thermometer. Maximum intraprocedural pain scores were analyzed, together with the pain scores reported at follow-up intervals through 3 months. The treatment pain scores were reported by subjects post-procedure and was based on their recollections. Scale is 0-12 with higher scores corresponding to higher pain reported.
Time Frame	Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure

Outcome Measure Data

Analysis Population Description

Subjects with data at the scheduled visits are included in the data summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Pain Score on day of Treatment	4.0 (3.3)
Pain Score 1 Day Post-Treatment	1.9 (2.3)
Pain Score 1 Week Post-Treatment	1.9 (2.6)
Pain Score 1 Month Post-Treatment	1.2 (2.1)
Pain Score 3 Months Post-Treatment	0.5 (1.6)

16. Secondary Outcome

Title	Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)
Description	Change in Quality of Life was measured using a QoL question in the IPSS. QoL data were collected at each follow up visit. One question in the IPSS asked subjects to rate their "quality of life due to urinary symptoms" on a scale of 0 = Delighted to 6 = Terrible. A reduction in score from baseline equates to improved outcome.
Time Frame	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Change from Baseline in IPSS QoL Score at 1 Week	-0.3 (1.4)
Change from Baseline in IPSS QoL Score at 1 Month	-1.1 (1.8)
Change from Baseline in IPSS QoL Score at 3 Months	-2.7 (1.6)
Change from Baseline in IPSS QoL Score at 6 Months	-2.7 (1.7)
Change from Baseline in IPSS QoL Score at 12 Months	-2.7 (1.5)
Change in IPSS QoL Change from Baseline in IPSS QoL Score at 24 Months	-2.6 (1.7)
Change from Baseline in IPSS QoL Score at 36 Months	-2.4 (2.1)
Change from Baseline in IPSS QoL Score at 48 Months	-2.5 (1.6)
Change from Baseline in IPSS QoL Score at 60 Months	-1.6 (1.8)

17. Secondary Outcome

Title	Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)
Description	Change in Quality of Life will be measured with the Benign Prostatic Hyperplasia Impact Index (BPHII). Data were collected at specified follow up visits. BPHII scores range from 0 (no/mild symptoms) to 35 (severe symptoms). A reduction in score from baseline equates to an improvement in symptoms.
Time Frame	Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Change from Baseline in BPHII Score at 1 Month	-1.0 (3.7)
Change from Baseline in BPHII Score at 3 Months	-4.4 (2.9)
Change from Baseline in BPHII Score at 6 Months	-4.5 (3.1)
Change from Baseline in BPHII Score at 12 Months	-4.3 (2.8)
Change from Baseline in BPHII Score at 24 Months	-4.4 (3.2)
Change from Baseline in BPHII Score at 36 Months	-3.5 (4.0)
Change from Baseline in BPHII Score at 48 Months	-4.0 (3.5)
Change from Baseline in BPHII Score at 60 Months	-2.1 (4.2)

18. Secondary Outcome

Title	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L
Description	Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. EQ-5D-3L index ranges from -0.109 to 1.000, with 1.000 corresponding to the best health state and -0.109 corresponding to the worst health. Mean change in overall score from baseline is reported.
Time Frame	1 month, 3 months, 6 months, 1 year, then annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Change from Baseline in EQ-5D-3L Overall Score at 1 Month	-0.0 (0.2)
Change from Baseline in EQ-5D-3L Overall Score at 3 Month	0.0 (0.2)
Change from Baseline in EQ-5D-3L Overall Score at 6 Month	0.1 (0.1)
Change from Baseline in EQ-5D-3L Overall Score at 12 Month	0.0 (0.1)
Change from Baseline in EQ-5D-3L Overall Score at 24 Month	0.0 (0.1)
Change from Baseline in EQ-5D-3L Overall Score at 36 Month	0.0 (0.1)
Change from Baseline in EQ-5D-3L Overall Score at 48 Month	-0.0 (0.2)
Change from Baseline in EQ-5D-3L Overall Score at 60 Month	-0.1 (0.1)

19. Secondary Outcome

Title	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)
Description	Quality of Life was measured using EQ-5D-3L questionnaire and collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. The EQ-5D-3L includes a visual analog scale (VAS) which is a vertical scale with numbers ranging from 0 to 100. Subjects were asked to draw a line to the place on the scale that best represented how good or bad his health was on that day. The worst state a subject can imagine is marked zero, and the best state the subject can imagine is marked 100. Mean change in VAS score from baseline is reported. An increase in score is considered a better outcome.
Time Frame	1 month, 3 months, 6 months, 1 year, then annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Change from Baseline in EQ-5D-3L VAS Score at 1 Month	2.8 (18.0)
Change from Baseline in EQ-5D-3L VAS Score at 3 Month	8.3 (18.3)
Change from Baseline in EQ-5D-3L VAS Score at 6 Month	9.1 (14.5)
Change from Baseline in EQ-5D-3L VAS Score at 12 Month	7.4 (19.7)
Change from Baseline in EQ-5D-3L VAS Score at 24 Month	5.8 (18.3)
Change from Baseline in EQ-5D-3L VAS Score at 36 Month	9.2 (20.9)
-0.1Change from Baseline in EQ-5D-3L VAS Score at 48 Month	6.5 (17.9)
Change from Baseline in EQ-5D-3L VAS Score at 60 Month	-0.1 (11.9)

20. Secondary Outcome

Title	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L
Description	Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. Each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Presented below are the scoring counts for each of the dimensions for baseline and follow up interval.
Time Frame	1 month, 3 months, 6 months, 1 year, then annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Level 1 (No Problems)	32 64%
Level 2 (Some Problems)	16 32%
Level 3 (Extreme Problems)	2 4%
Level 1 (No Problems)	39 78%
Level 2 (Some Problems)	8 16%
Level 3 (Extreme Problems)	2 4%
Level 1 (No Problems)	41 82%
Level 2 (Some Problems)	6 12%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	40 80%
Level 2 (Some Problems)	6 12%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	35 70%
Level 2 (Some Problems)	10 20%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	26 52%
Level 2 (Some Problems)	8 16%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	22 44%
Level 2 (Some Problems)	5 10%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	19 38%
Level 2 (Some Problems)	7 14%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	5 10%
Level 2 (Some Problems)	2 4%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	43 86%
Level 2 (Some Problems)	7 14%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	43 86%
Level 2 (Some Problems)	6 12%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	43 86%
Level 2 (Some Problems)	5 10%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	40 80%
Level 2 (Some Problems)	6 12%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	37 74%
Level 2 (Some Problems)	8 16%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	27 54%
Level 2 (Some Problems)	7 14%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	17 34%
Level 2 (Some Problems)	10 20%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	15 30%
Level 2 (Some Problems)	10 20%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	3 6%
Level 2 (Some Problems)	4 8%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	22 44%
Level 2 (Some Problems)	25 50%
Level 3 (Extreme Problems)	1 2%
Level 1 (No Problems)	24 48%
Level 2 (Some Problems)	20 40%
Level 3 (Extreme Problems)	2 4%
Level 1 (No Problems)	32 64%
Level 2 (Some Problems)	15 30%
Level 3 (Extreme Problems)	1 2%
Level 1 (No Problems)	30 60%
Level 2 (Some Problems)	16 32%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	28 56%
Level 2 (Some Problems)	16 32%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	20 40%
Level 2 (Some Problems)	12 24%
Level 3 (Extreme Problems)	1 2%
Level 1 (No Problems)	17 34%
Level 2 (Some Problems)	9 18%
Level 3 (Extreme Problems)	1 2%
Level 1 (No Problems)	12 24%
Level 2 (Some Problems)	12 24%
Level 3 (Extreme Problems)	2 4%
Level 1 (No Problems)	4 8%
Level 2 (Some Problems)	2 4%
Level 3 (Extreme Problems)	1 2%
Level 1 (No Problems)	50 100%
Level 2 (Some Problems)	0 0%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	48 96%
Level 2 (Some Problems)	0 0%
Level 3 (Extreme Problems)	1 2%
Level 1 (No Problems)	47 94%
Level 2 (Some Problems)	1 2%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	46 92%
Level 2 (Some Problems)	0 0%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	45 90%
Level 2 (Some Problems)	0 0%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	33 66%
Level 2 (Some Problems)	1 2%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	26 52%
Level 2 (Some Problems)	1 2%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	24 48%
Level 2 (Some Problems)	1 2%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	6 12%
Level 2 (Some Problems)	1 2%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	47 94%
Level 2 (Some Problems)	3 6%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	40 80%
Level 2 (Some Problems)	7 14%
Level 3 (Extreme Problems)	2 4%
Level 1 (No Problems)	45 90%
Level 2 (Some Problems)	3 6%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	46 92%
Level 2 (Some Problems)	0 0%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	41 82%
Level 2 (Some Problems)	4 8%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	31 62%
Level 2 (Some Problems)	3 6%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	25 50%
Level 2 (Some Problems)	2 4%
Level 3 (Extreme Problems)	0 0%
Level 1 (No Problems)	20 40%
Level 2 (Some Problems)	4 8%
Level 3 (Extreme Problems)	1 2%
Level 1 (No Problems)	6 12%
Level 2 (Some Problems)	1 2%
Level 3 (Extreme Problems)	0 0%

21. Secondary Outcome

Title	Subject Satisfaction - Satisfied With Overall Procedure
Description	Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. These will be measured as: • Proportion of subjects that are satisfied with the procedure overall Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.
Time Frame	1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Very Satisfied	16 32%
Satisfied	23 46%
Neither Satisfied or Dissatisfied (Neutral)	6 12%
Dissatisfied	2 4%
Very Dissatisfied	1 2%
Very Satisfied	18 36%
Satisfied	19 38%
Neither Satisfied or Dissatisfied (Neutral)	8 16%
Dissatisfied	2 4%
Very Dissatisfied	0 0%
Very Satisfied	21 42%
Satisfied	22 44%
Neither Satisfied or Dissatisfied (Neutral)	3 6%
Dissatisfied	1 2%
Very Dissatisfied	0 0%
Very Satisfied	18 36%
Satisfied	20 40%
Neither Satisfied or Dissatisfied (Neutral)	7 14%
Dissatisfied	2 4%
Very Dissatisfied	0 0%
Very Satisfied	19 38%
Satisfied	19 38%
Neither Satisfied or Dissatisfied (Neutral)	6 12%
Dissatisfied	1 2%
Very Dissatisfied	0 0%
Very Satisfied	12 24%
Satisfied	12 24%
Neither Satisfied or Dissatisfied (Neutral)	3 6%
Dissatisfied	0 0%
Very Dissatisfied	0 0%
Very Satisfied	11 22%
Satisfied	8 16%
Neither Satisfied or Dissatisfied (Neutral)	4 8%
Dissatisfied	0 0%
Very Dissatisfied	0 0%
Very Satisfied	10 20%
Satisfied	11 22%
Neither Satisfied or Dissatisfied (Neutral)	3 6%
Dissatisfied	2 4%
Very Dissatisfied	0 0%
Very Satisfied	1 2%
Satisfied	4 8%
Neither Satisfied or Dissatisfied (Neutral)	2 4%
Dissatisfied	0 0%
Very Dissatisfied	0 0%

22. Secondary Outcome

Title	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family
Description	Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects that would recommend this treatment to friends and families Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.
Time Frame	1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Definitely Will	26 52%
Probably Will	14 28%
Not Sure	7 14%
Probably Will Not	1 2%
Definitely Will not	0 0%
Definitely Will	24 48%
Probably Will	16 32%
Not Sure	6 12%
Probably Will Not	2 4%
Definitely Will not	0 0%
Definitely Will	33 66%
Probably Will	10 20%
Not Sure	4 8%
Probably Will Not	1 2%
Definitely Will not	0 0%
Definitely Will	29 58%
Probably Will	12 24%
Not Sure	5 10%
Probably Will Not	1 2%
Definitely Will not	0 0%
Definitely Will	30 60%
Probably Will	12 24%
Not Sure	3 6%
Probably Will Not	0 0%
Definitely Will not	0 0%
Definitely Will	18 36%
Probably Will	8 16%
Not Sure	1 2%
Probably Will Not	0 0%
Definitely Will not	0 0%
Definitely Will	17 34%
Probably Will	5 10%
Not Sure	1 2%
Probably Will Not	0 0%
Definitely Will not	0 0%
Definitely Will	17 34%
Probably Will	8 16%
Not Sure	1 2%
Probably Will Not	0 0%
Definitely Will not	0 0%
Definitely Will	4 8%
Probably Will	1 2%
Not Sure	2 4%
Probably Will Not	0 0%
Definitely Will not	0 0%

23. Secondary Outcome

Title	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years
Description	Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects who would undergo the same treatment if their symptoms were to recur after 5 years Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different "n" by question within the same follow-up time point.
Time Frame	1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Outcome Measure Data

Analysis Population Description

Subjects with data at baseline and follow-up visit are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Very Likely	23 46%
Likely	17 34%
Not Sure	6 12%
Unlikely	1 2%
Very Unlikely	0 0%
Very Likely	17 34%
Likely	21 42%
Not Sure	8 16%
Unlikely	2 4%
Very Unlikely	0 0%
Very Likely	27 54%
Likely	15 30%
Not Sure	5 10%
Unlikely	0 0%
Very Unlikely	0 0%
Very Likely	25 50%
Likely	13 26%
Not Sure	8 16%
Unlikely	1 2%
Very Unlikely	0 0%
Very Likely	29 58%
Likely	10 20%
Not Sure	5 10%
Unlikely	0 0%
Very Unlikely	1 2%
Very Likely	12 24%
Likely	12 24%
Not Sure	2 4%
Unlikely	0 0%
Very Unlikely	1 2%
Very Likely	10 20%
Likely	8 16%
Not Sure	2 4%
Unlikely	3 6%
Very Unlikely	0 0%
Very Likely	12 24%
Likely	8 16%
Not Sure	5 10%
Unlikely	1 2%
Very Unlikely	0 0%
Very Likely	1 2%
Likely	3 6%
Not Sure	3 6%
Unlikely	0 0%
Very Unlikely	0 0%

24. Secondary Outcome

Title	Procedural Parameters - Procedure Time
Description	Procedure time: Time from delivery device insertion to final delivery device withdrawal
Time Frame	Day of Procedure

Outcome Measure Data

Analysis Population Description

Subjects with procedure data are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Mean (Standard Deviation) [minutes]	6.7 (5.8)

25. Secondary Outcome

Title	Procedural Parameters - Treatment Time
Description	Treatment time: time from first vapor delivery to last vapor delivery
Time Frame	Day of Procedure

Outcome Measure Data

Analysis Population Description

Subjects with procedure data are included in the summarization.

Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
Measure Participants	50
Mean (Standard Deviation) [minutes]	4.5 (4.9)

Adverse Events

Time Frame	Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
Arm/Group Title	Rezum Treatment
Arm/Group Description	Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
All Cause Mortality
	Rezum Treatment
	Affected / at Risk (%)	# Events
Total	2/50 (4%)
Serious Adverse Events
	Rezum Treatment
	Affected / at Risk (%)	# Events
Total	8/50 (16%)
Cardiac disorders
Cardiac Event	1/50 (2%)	1
Gastrointestinal disorders
Weakness or Fatigue	1/50 (2%)	1
Diarrhea	1/50 (2%)	1
General disorders
Other	2/50 (4%)	5
Infections and infestations
Infection Other than UTI	1/50 (2%)	2
Musculoskeletal and connective tissue disorders
Pain/Discomfort - Pelvic	1/50 (2%)	1
Renal and urinary disorders
Urinary Retention	3/50 (6%)	5
Urinary Frequency	1/50 (2%)	1
Cancer -Other	1/50 (2%)	1
Urinary Tract Infection-Proven	1/50 (2%)	1
Poor Stream	1/50 (2%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Rezum Treatment
	Affected / at Risk (%)	# Events
Total	38/50 (76%)
Gastrointestinal disorders
Abdominal Bloating with Gas	1/50 (2%)	1
Constipation	1/50 (2%)	1
Diverticulitis	1/50 (2%)	1
General disorders
Other	4/50 (8%)	5
Pain/Discomfort	7/50 (14%)	7
Pain/Discomfort - Pelvic	1/50 (2%)	2
Dizziness	1/50 (2%)	1
Injury - Other	1/50 (2%)	1
Pain/Discomfort - Back	1/50 (2%)	1
Pain/Discomfort - Perineum	1/50 (2%)	1
Musculoskeletal and connective tissue disorders
Spinal Stenosis	1/50 (2%)	1
Renal and urinary disorders
Urinary Retention	15/50 (30%)	18
Urinary Urgency	15/50 (30%)	16
Dysuria	10/50 (20%)	10
Poor Stream	8/50 (16%)	9
UTI - Suspected	9/50 (18%)	10
Nocturia	6/50 (12%)	7
Hematuria - Gross	4/50 (8%)	6
Urinary Incontinence - Urge	3/50 (6%)	5
Urinary Frequency	2/50 (4%)	3
Hesitancy	3/50 (6%)	3
Urethral Secretion w/o Hematuria or Stones	3/50 (6%)	3
Pain/Discomfort with Scrotum	2/50 (4%)	2
Bladder Spasms	1/50 (2%)	1
Cancer - Prostate	1/50 (2%)	1
Prostatic Cyst De Novo	1/50 (2%)	1
Terminal Dribbling	1/50 (2%)	1
Urinary Incontinence - Not Specified	1/50 (2%)	1
Skin and subcutaneous tissue disorders
Epididymitis	1/50 (2%)	1

Limitations/Caveats

This was a pilot study conducted on a new therapy at a limited number of sites (3 total).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.