OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

Recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Other: Data collection

• Registration Number: NCT06560476
• Lead Sponsor: Urotronic Inc.

Brief Summary

APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-30
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2027-03-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

1. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).

Read More

Exclusion Criteria

1. 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
2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
3. Confirmed or suspected malignancy of prostate or bladder.
4. Active urinary tract infection (UTI)
5. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Arm	Data collection	This is the data collection study arm. There is no other arm in the study.

Primary Outcome Measures

Name	Time	Method
The primary safety endpoint is the freedom from treatment-related adverse SAEs.	Baseline to 12 months	The primary safety endpoint is the freedom from treatment-related adverse SAEs.
The primary efficacy endpoint is the average IPSS change from baseline to 12 months.	Baseline to 12 months	The primary efficacy endpoint is the average IPSS change from baseline to 12 months.; The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms.; It is a validated, reproducible scoring system to assess disease severity and response to therapy.; The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.; It is not a reliable diagnostic tool for lower urinary tract symptoms (LUTS) suggestive of BPH, but can be used to quantitatively measure LUTS after a diagnosis is made.

Secondary Outcome Measures

Name	Time	Method
Change in Qmax (mL per second) over time	From baseline to through study completion, an average of 2 years.	Uroflowmetry represents an objective measure of relief of obstruction. Average peak urinary flow rate (Qmax) and change from baseline will be reported at each follow-up timepoint.; Uroflowmetry assesses flow pattern, flow curve shape, maximum urinary flow (Qmax), voided volume (VV), voiding time (VT), PVR volume (PVR). A minimum of 150ml is required to provide an accurate assessment in men
Frequency and severity of treatment-related AEs	From baseline to through study completion, an average of 2 years.	Adverse events will be collected and assessed for relatedness to the device and the procedure as well as for severity. The Clavien-Dindo severity grading scale is a commonly used criteria in the urology community.
Freedom from repeat intervention (time-to-event)	From baseline to through study completion, an average of 2 years.	The proportion of subjects free from repeat surgical or endoscopic intervention for BPH will be reported over time utilizing the Kaplan-Meier method.
Change in IPSS over time	From baseline to through study completion, an average of 2 years.	The IPSS tool is the most commonly reported symptom score for obstructive urinary symptoms secondary to BPH. Average IPSS scores, absolute change from baseline, and percent change from baseline will be reported at each follow-up timepoint.; The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms.; It is a validated, reproducible scoring system to assess disease severity and response to therapy.; The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.; It is not a reliable diagnostic tool for lower urinary tract symptoms (LUTS) suggestive of BPH, but can be used to quantitatively measure LUTS after a diagnosis is made.
Change in PVR over time	From baseline to through study completion, an average of 2 years.	Residual urine in the bladder due to incomplete emptying is an important clinical consideration in subjects with obstructive BPH. Average PVR and change from baseline will be reported at each follow-up timepoint.; Post-void residual volume (PVR) is the amount of urine retained in the bladder after a voluntary void and functions as a diagnostic tool. A PVR can be used to assess many disease processes, including but not limited to neurogenic bladder, cauda equina syndrome, urinary outlet obstruction, mechanical obstruction, medication-induced urinary retention, postoperative urinary retention, and urinary tract infections. The PVR may be determined through urinary catheterization, a portable dedicated bladder scanner, or a formal ultrasound examination.

Trial Locations

Locations (4)

Good Samaritan Hospital; 🇺🇸 Corvallis, Oregon, United States

Kearney Urology Center; 🇺🇸 Kearney, Nebraska, United States

Adult & Pediatric Urology, PC; 🇺🇸 Omaha, Nebraska, United States

Potomac Urology; 🇺🇸 Woodridge, Virginia, United States