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

Dean Elterman

Status: Not yet enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: Optilume Catheter System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05567666

SUMMIT (Protocol no.: 1001)

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Treatment

Experimental group

Description:

Optilume Catheter System

Treatment:

Device: Optilume Catheter System