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

A Real-word, Clinical Study to Evaluate the Performance of the Optilume® BPH Catheter System in Men With Symptomatic Benign Prostatic Hyperplasia (BPH)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Optilume Catheter System

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iris Chan; Phone Number: 5033 416-603-5800; Email: Iris.Chan2@uhn.ca
• Study Contact Backup: Name: Dean Elterman; Email: dean.elterman@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Responder Rate at 12 months	≥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)	12 months post treatment
Safety (adverse events)	Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.	Within 12 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IPSS & IPSS QoL (questionnaire)	IPSS & IPSS QoL questionnaire	12 months post treatment
Change in Qmax (maximum flow rate)	Uroflow to measure maximum flow rate	12 months post treatment
Change in PVR (post-void residual)	Bladder scanner to measure post-void residual	12 months post treatment
Change in sexual function (International Index of Erectile Function, IIEF questionnaire)	IIEF questionnaire. Lower score in IIEF means worse in erectile dysfunction.	12 months post treatment
Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire)	MSHQ-EjD questionnaire. Lower score in MSHQ-EjD means worse in ejaculation function.	12 months post treatment
Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days.	QoR VAS questionnaire. Higher score means good in recovery.	30 days post treatment
Health care usage	Procedure time	30 days post treatment
Health care usage	Readmission rate within 30days	30 days post treatment
Rate of repeat surgical intervention	Number of participants that need repeated surgical intervention	12 months post treatment

Collaborators and Investigators

• Sponsor: Dean Elterman
• Collaborators: Urotronic Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Optilume; MIST
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: SUMMIT (Protocol no.: 1001)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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