Health TrialsbyHealthPanel

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

ConditionBenign Prostatic Hyperplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorUrotronic Inc.

About this trial

The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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%.

Trial design

Design model

Single group

Treatments tested in this trial

  • Optilume® BPH Catheter System

    Device

    The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.

Treatment groups

92 Participants
are divided into 1 treatment group
Group A: Study ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in International Prostate Symptom Score (IPSS)

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.

Time frame
Baseline to 12 months
2

Rate of a composite of treatment-related serious adverse events (SAEs)

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

Time frame
3 months

Secondary outcomes

1

Change in Sperm Concentration

For the Semen Sub-Study, the average change from baseline in sperm concentration at 13 weeks (3 months) post-procedure will be compared against a performance goal of -30% (30% decrease from baseline).

Time frame
Baseline to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Urotronic Inc.

Lead sponsor

Source ClinicalTrials.gov
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