Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)

Study Overview
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Brief Summary
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A post-marketing study using Optilume Catheter System for benign prostatic hyperplasia.

Detailed Description
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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.

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Optilume Catheter System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Able to complete the study protocol in the opinion of the investigator Exclusion Criteria: Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements 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 Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate Confirmed or suspected malignancy of prostate or bladder Active urinary tract infection (UTI) confirmed by culture History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable 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.) History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage) Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System Significant obstruction from median lobe in the opinion of the investigator Disease or other health condition that is not suitable for this study
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Optilume Catheter System | Device: Optilume Catheter System<br>* Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optilume, MIST