SUMMIT: Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)

• Sponsor: Dean Elterman (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05567666
• Collaborator: Urotronic Inc. (Industry)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 25.5

Study Details

Study Description

Brief Summary

A post-marketing study using Optilume Catheter System for benign prostatic hyperplasia.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Device: Optilume Catheter System	N/A

Detailed Description

This is a post-marketing study for using Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter, to treat benign prostatic hyperplasia. Participants will go through screening process which include uroflow test (measure the strength of urine flow), post-void residual volume by bladder scan, questionnaires and transrectal ultrasound (TRUS) to determine the eligibility to the study. Participants will be followed up for 1 year after Optilume treatment procedure.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter.Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Real-word, Clinical Study to Evaluate the Performance of the Optilume® BPH Catheter System in Men With Symptomatic Benign Prostatic Hyperplasia (BPH)
• Anticipated Study Start Date: Nov 15, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Optilume Catheter System	Device: Optilume Catheter System; Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter

Outcome Measures

Primary Outcome Measures

1. Efficacy: Responder Rate at 12 months [12 months post treatment]

   ≥30% improvement in International Prostate Symptom Score (IPSS) score without the need of an additional surgical or minimally invasive procedure. IPSS score ranges from 0-35 (higher score means worse symptoms)

2. Safety (adverse events) [Within 12 months post treatment]

   Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.

Secondary Outcome Measures

1. Change in IPSS & IPSS QoL (questionnaire) [12 months post treatment]

   IPSS & IPSS QoL questionnaire

2. Change in Qmax (maximum flow rate) [12 months post treatment]

   Uroflow to measure maximum flow rate

3. Change in PVR (post-void residual) [12 months post treatment]

   Bladder scanner to measure post-void residual

4. Change in sexual function (International Index of Erectile Function, IIEF questionnaire) [12 months post treatment]

   IIEF questionnaire. Lower score in IIEF means worse in erectile dysfunction.

5. Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire) [12 months post treatment]

   MSHQ-EjD questionnaire. Lower score in MSHQ-EjD means worse in ejaculation function.

6. Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days. [30 days post treatment]

   QoR VAS questionnaire. Higher score means good in recovery.

7. Health care usage [30 days post treatment]

   Procedure time

8. Health care usage [30 days post treatment]

   Readmission rate within 30days

9. Rate of repeat surgical intervention [12 months post treatment]

   Number of participants that need repeated surgical intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male subject with symptomatic BPH NOTE: Symptomatic BPH is defined as an International Prostate Symptom Score (IPSS) ≥ 13 and peak urinary flow rate (Qmax) of ≤15 mL/sec

2. Prostate dimensions suitable for treatment with the Optilume BPH Catheter System in accordance with the approved Instructions for Use NOTE: Prostate volume between 20 to 80 gm and prostatic urethral length between 32 mm and 55 mm as determined by TRUS

3. Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria:

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

2. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and a highly effective contraceptive for at least 6 months post-procedure

3. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate

4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate

5. Confirmed or suspected malignancy of prostate or bladder

6. Active urinary tract infection (UTI) confirmed by culture

7. History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable

8. Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g. urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.)

9. History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage)

10. Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System

11. Significant obstruction from median lobe in the opinion of the investigator

12. Disease or other health condition that is not suitable for this study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Dean Elterman
• Urotronic Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dean Elterman, Lead Principal Investigator, Can-Am HIFU Inc.
• ClinicalTrials.gov Identifier: NCT05567666
• Other Study ID Numbers: SUMMIT (Protocol no.: 1001)
• First Posted: Oct 5, 2022
• Last Update Posted: Oct 5, 2022
• Last Verified: Sep 1, 2022

• 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.: Yes
• Keywords provided by Dean Elterman, Lead Principal Investigator, Can-Am HIFU Inc.: Optilume; MIST
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

No Results Posted as of Oct 5, 2022