Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Urotronic Inc.
- Enrollment
- 92
- Locations
- 7
- Primary Endpoint
- Change in International Prostate Symptom Score (IPSS)
Study Overview
Brief Summary
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Detailed Description
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
STUDY ENDPOINTS
Primary Efficacy Endpoint:
The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months.
Primary Safety Endpoint:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male subject ≥ 50 years old
- •Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
- •Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
- •Prostate volume < 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
- •International Prostate Symptom Score (IPSS) ≥ 13
- •Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL
- •Willing to provide informed consent and comply with protocol required follow-up
Exclusion Criteria
- •Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
- •Presence of an artificial urinary sphincter, penile prosthesis, 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. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is > 4 ng/mL with free PSA < 25%.
- •Active urinary tract infection (UTI) confirmed by culture
- •Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
- •History of overt urinary incontinence requiring the use of pads
- •Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
- •Current post-void residual volume (PVR) > 300 mL or catheter dependent bladder drainage
- •Known poor detrusor muscle function (e.g., Qmax < 5 mL/sec)
- •Active bladder, ureteral, or urethral stones or stone passage within the last 3 months
- •Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%)
- •Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
- •Obstructive median lobe in the opinion of the investigator
Arms & Interventions
Study Arm
Optilume BPH Catheter System
Intervention: Optilume® BPH Catheter System (Device)
Outcomes
Primary Outcomes
Change in International Prostate Symptom Score (IPSS)
Time Frame: Baseline to 12 months
The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months. The first seven questions in the International Prostate Symptom Score (IPSS) questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic.
Rate of a composite of treatment-related serious adverse events (SAEs)
Time Frame: 3 months
The primary safety endpoint is the rate of a composite of the specified treatment-related serious adverse events through 3 months post-treatment: * De novo severe urinary retention lasting \>14 days post-procedure * De novo severe stress urinary incontinence requiring surgical management * Formation of a fistula between the rectum and urethra * Perforation of the rectum or GI tract * Bleeding requiring transfusion or endoscopic intervention
Secondary Outcomes
- Change in Sperm Concentration(Baseline to 3 months)