Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06560476 · ClinicalTrials.gov registry record
OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
A clinical trial of Benign Prostatic Hyperplasia, sponsored by Urotronic.
- Recruiting
- Registry status
- 500
- Enrollment target
- 9
- Study locations
NCT06560476: Recruiting study of Benign Prostatic Hyperplasia, sponsored by Urotronic.
NCT06560476 is a study of Benign Prostatic Hyperplasia that is actively recruiting participants, run by Urotronic. The registered enrollment target is 500 participants, roughly in line with the 535-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target. The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06560476, a study of Benign Prostatic Hyperplasia, is actively recruiting participants, sponsored by Urotronic.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
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 no
Conditions Studied
Interventions
- OTHER Data collection
Study Locations (9)
Nebraska
- Kearney Urology Center - Kearney
- The Urology Center, P.C. - Omaha
California
- Golden State Urology - Sacramento
Florida
- Florida Urology Partners - Tampa
Nevada
- Sheldon Freedman, Ltd - Las Vegas
New York
- Northwell Health - Smith Institute of Urology - Syosset
Oregon
- Good Samaritan Hospital - Corvallis
Texas
- Midtown Urology - Austin
Virginia
- Potomac Urology - Woodridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-03-30 |
| Est. Completion | 2027-03-30 |
What NCT06560476 shows while recruiting
NCT06560476 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 535-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target.
The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 1 intervention - of which Data collection is the first listed.
NCT06560476 lists 9 locations in 8 states (Nebraska, California, Florida).
Frequently Asked Questions
What is clinical trial NCT06560476 about?
NCT06560476 is a clinical study titled "OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH". APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.
What is the current status of trial NCT06560476?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2024-03-30. Estimated completion is 2027-03-30.
What conditions does trial NCT06560476 study?
This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.
What interventions are being tested in trial NCT06560476?
The interventions under investigation include: Data collection (OTHER).
Who is sponsoring clinical trial NCT06560476?
This trial is sponsored by Urotronic, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06560476 being conducted?
This trial has 9 study locations across California, Florida, Nebraska, Nevada, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Benign Prostatic Hyperplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06560476's enrollment target sits among peer trials
500 5th of 29 higher than 25 of 29 other Benign Prostatic Hyperplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Benign Prostatic Hyperplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Customized TULSA-PRO Ablation Registry
RECRUITING
-
Ambulatory Long Length URodynamics Evaluation
RECRUITING · NA
-
Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
RECRUITING · NA
-
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
RECRUITING · NA
-
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
RECRUITING · NA
-
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00001230 · 500 participants
Host Response to Infection and Treatment in Filarial Diseases
- NCT00001529 · 500 participants
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
- NCT00697411 · 500 participants
Study of Selected X-Linked Disorders: Aicardi Syndrome
- NCT00903110 · 500 participants
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI