Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy

• Sponsor: Benaroya Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04098809
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.9
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

This study is designed to assess the effect of catheter size on postoperative catheter pain, urinary continence, urinary flow rates, post void residuals, International Prostate Symptom Scores (IPSS), and Quality of Life (QoL) score, as well as long term complications after robotic assisted laparoscopic prostatectomy.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: 16 French urinary catheter; Device: 20 French urinary catheter	N/A

Detailed Description

Subjects identified to receive a robotic assisted laparoscopic prostatectomy.were randomized to either a 16 French or 20 French catheter at the completion of the prostatectomy. All prostatectomies were performed by one of three surgeons at the investigator's institution. Preoperative demographics and operative data were recorded for each group. Catheters remained in place for 7-14 days. Subjects were asked on postoperative day 7 to report their catheter-related pain and amount of opioid medication used. Urinary symptoms and quality of life scores and pads per day were recorded at 6 weeks and 12 weeks post-operatively.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy
• Actual Study Start Date: Nov 9, 2017
• Actual Primary Completion Date: Nov 7, 2018
• Actual Study Completion Date: Nov 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Catheter 16 French 16 French urinary catheter	Device: 16 French urinary catheter; 16 French urinary catheter
Active Comparator: Catheter 20 French 20 French urinary catheter	Device: 20 French urinary catheter; 20 French urinary catheter

Outcome Measures

Primary Outcome Measures

1. Catheter Related Pain: Visual Analog Score Rating [post-op day 5-7]

   Catheter related pain was measured using a visual analog score rating mean post-operative pain on a scale from 1 (no pain) to 10 (worst possible pain). The lower the score the better the outcome.

Secondary Outcome Measures

1. Urinary Symptoms [week 6]

   The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The lower the score the better the outcome.

2. Quality of Life Score [Week 6]

   Question eight of IPSS refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome.

3. Urinary Symptoms [week 12]

   The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The lower the score the better the outcome. Question eight refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome.

4. Quality of Life Score [Week 12]

   Question eight of the International Prostate Symptom Score (IPSS) refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome

5. Opioid Use [after discharge until post-op day 7]

   Patient reported use of the number of tablets taken from provided prescription of opioids for post-operative pain. This will be converted to a standardized morphine equivalency for comparison. The lower the value the better the outcome.

6. Home Opioid Use in Standard Morphine Equivalency [after discharge until post-op day 7]

   Patient reported use of the number of tablets taken from provided prescription of opioids for post-operative pain. This will be converted to a standardized morphine equivalency for comparison. The lower the value the better the outcome.

7. Number of Incontinence Pads Used [week 6]

   Patient reported number of incontinence pads used per day. The lower the number the better the outcome.

8. Patient Reported Number of Pads Used Per Day. [Week 12]

   Patient reported number of incontinence pads used per day. The lower the number the better the outcome.

9. Number of Participants Experiencing Bladder Neck Contracture [week 12]

   Number of incidence of participants experiencing bladder neck contracture.

10. Number of Participants Experiencing Bladder Neck Contracture [1 year]

    Number of Incidence of participants experiencing bladder neck contracture.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Identified as candidate for robotic assisted laparoscopic prostatectomy

Exclusion Criteria:

• Having filled a prescription for opioid medication in last 2 months.

• Known latex allergy

• Known pre-operatively that catheter placement will exceed 14 days

• History of pelvic radiation

• Significant deviation from normal operative protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Mason Medical center	Seattle	Washington	United States	98101

Sponsors and Collaborators

• Benaroya Research Institute

Investigators

• Principal Investigator: John Corman, MD, Virginia Mason Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 20, 2018

More Information

Publications

None provided.

• Responsible Party: Benaroya Research Institute
• ClinicalTrials.gov Identifier: NCT04098809
• Other Study ID Numbers: IRB17-095
• First Posted: Sep 23, 2019
• Last Update Posted: Dec 26, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter	20 French urinary catheter
Period Title: Overall Study
STARTED	27	25
COMPLETED	24	21
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Catheter 16 French	Catheter 20 French	Total
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	Total of all reporting groups
Overall Participants	24	21	45
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.17 (7.01)	62.57 (5.95)	62.89 (6.47)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	24 100%	21 100%	45 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27.77 (3.25)	27.02 (3.33)	27.42 (3.27)
Prior Abdominal Surgery (Count of Participants)
Prior Abdominal Surgery - No	14 58.3%	17 81%	31 68.9%
Prior Abdominal Surgery - Yes	10 41.7%	4 19%	14 31.1%
Chronic Pain (Count of Participants)
Chronic Pain - No	23 95.8%	20 95.2%	43 95.6%
Chronic Pain - Yes	1 4.2%	1 4.8%	2 4.4%
Previous Transurethral Resection of Prostate (TURP) (Count of Participants)
Previous TURP - No	23 95.8%	21 100%	44 97.8%
Previous TURP -Yes	1 4.2%	0 0%	1 2.2%
International Prostate Symptom Score (score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score]	9.24 (6.09)	10.00 (5.78)	9.59 (5.88)
Baseline Quality of Life (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	1.65 (1.27)	2.11 (1.18)	1.89 (1.23)
International Index of Erectile Function (score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score]	18.85 (6.83)	17.39 (7.57)	18.16 (7.13)
TNM Stage (Count of Participants)
T2N0	6 25%	4 19%	10 22.2%
T2NX	5 20.8%	6 28.6%	11 24.4%
T2cN0	1 4.2%	1 4.8%	2 4.4%
T3aN0	9 37.5%	10 47.6%	19 42.2%
T3bN0	2 8.3%	0 0%	2 4.4%
T3bN1	1 4.2%	0 0%	1 2.2%
Gleason Score (Count of Participants)
Gleason 6	7 29.2%	7 33.3%	14 31.1%
Gleason 7	17 70.8%	13 61.9%	30 66.7%
Gleason 8	0 0%	1 4.8%	1 2.2%
Extra Prostatic Extension (Count of Participants)
Extra Prostatic Extension - No	12 50%	11 52.4%	23 51.1%
Extra Prostatic Extension - Yes	12 50%	10 47.6%	22 48.9%
Seminal Vesical Invasion (Count of Participants)
Seminal Vesical Invasion - No	21 87.5%	21 100%	42 93.3%
Seminal Vesical Invasion -Yes	3 12.5%	0 0%	3 6.7%
Pelvic Lymph Node Dissection (PLND) (Count of Participants)
PLND - No	5 20.8%	5 23.8%	10 22.2%
PLND -Yes	19 79.2%	16 76.2%	35 77.8%
weight of prostate (grams) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [grams]	69.53 (35.92)	54.30 (14.79)	62.42 (28.66)
Operative time (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	186.4 (54.6)	171.4 (32.3)	179.4 (45.7)

Outcome Measures

1. Primary Outcome

Title	Catheter Related Pain: Visual Analog Score Rating
Description	Catheter related pain was measured using a visual analog score rating mean post-operative pain on a scale from 1 (no pain) to 10 (worst possible pain). The lower the score the better the outcome.
Time Frame	post-op day 5-7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Mean (Standard Deviation) [score on a scale]	2.67 (1.61)	2.67 (1.68)

2. Secondary Outcome

Title	Urinary Symptoms
Description	The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The lower the score the better the outcome.
Time Frame	week 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Mean (Standard Deviation) [score on a scale]	9.81 (4.25)	7.95 (4.04)

3. Secondary Outcome

Title	Quality of Life Score
Description	Question eight of IPSS refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Mean (Standard Deviation) [score on a scale]	3 (1.3)	2.95 (1.72)

4. Secondary Outcome

Title	Urinary Symptoms
Description	The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The lower the score the better the outcome. Question eight refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Mean (Standard Deviation) [score on a scale]	6.52 (4.75)	7.59 (4.39)

5. Secondary Outcome

Title	Quality of Life Score
Description	Question eight of the International Prostate Symptom Score (IPSS) refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Mean (Standard Deviation) [score on a scale]	2.24 (1.3)	2.29 (1.05)

6. Secondary Outcome

Title	Opioid Use
Description	Patient reported use of the number of tablets taken from provided prescription of opioids for post-operative pain. This will be converted to a standardized morphine equivalency for comparison. The lower the value the better the outcome.
Time Frame	after discharge until post-op day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Mean (Standard Deviation) [tablets]	5.00 (5.68)	4.48 (5.75)

7. Secondary Outcome

Title	Home Opioid Use in Standard Morphine Equivalency
Description	Patient reported use of the number of tablets taken from provided prescription of opioids for post-operative pain. This will be converted to a standardized morphine equivalency for comparison. The lower the value the better the outcome.
Time Frame	after discharge until post-op day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Mean (Standard Deviation) [milligrams]	37.50 (42.60)	33.57 (43.12)

8. Secondary Outcome

Title	Number of Incontinence Pads Used
Description	Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
Time Frame	week 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Mean (Standard Deviation) [number of pads]	2.00 (1.50)	1.79 (1.32)

9. Secondary Outcome

Title	Patient Reported Number of Pads Used Per Day.
Description	Patient reported number of incontinence pads used per day. The lower the number the better the outcome.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Mean (Standard Deviation) [number of pads]	1.17 (1.46)	1.13 (0.96)

10. Secondary Outcome

Title	Number of Participants Experiencing Bladder Neck Contracture
Description	Number of incidence of participants experiencing bladder neck contracture.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Count of Participants [Participants]	0 0%	0 0%

11. Secondary Outcome

Title	Number of Participants Experiencing Bladder Neck Contracture
Description	Number of Incidence of participants experiencing bladder neck contracture.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter 16 French	Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.	20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
Measure Participants	24	21
Count of Participants [Participants]	0 0%	1 4.8%

Adverse Events

Time Frame	1 year
Arm/Group Title	Catheter 16 French		Catheter 20 French
Arm/Group Description	16 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.		20 French urinary catheter Patients will be randomized by chance to either a 16 French or 20 French catheter in a 1:1 ratio.
All Cause Mortality
	Catheter 16 French		Catheter 20 French
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/21 (0%)
Serious Adverse Events
	Catheter 16 French		Catheter 20 French
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Catheter 16 French		Catheter 20 French
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		1/21 (4.8%)
Renal and urinary disorders
bladder neck contracture	0/24 (0%)	0	1/21 (4.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.