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NCT06209307 · ClinicalTrials.gov registry record · NA
Pelvic Floor Physical Therapy to Reduce Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
A NA study of Stress Urinary Incontinence and Prostatic Hyperplasia, sponsored by University of California, Irvine.
- Active
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT06209307 is a NA study of Stress Urinary Incontinence and Prostatic Hyperplasia that is active but no longer recruiting, run by University of California, Irvine. The registered enrollment target is 72 participants, below the 161-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06209307, a NA study of Stress Urinary Incontinence and Prostatic Hyperplasia, is active but no longer recruiting, sponsored by University of California, Irvine.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
Holmium laser enucleation of the prostate (HoLEP) is a surgical procedure used to treat benign prostatic hyperplasia (BPH). HoLEP involves the removal of obstructive prostatic tissue via an endoscopic approach to relieve bothersome urinary symptoms. HoLEP is recommended by the American Urological Association (AUA) as a size-independent treatment for BPH. While the surgery is highly durable and versatile, post-operative stress urinary incontinence (SUI) has been reported following HoLEP, up to 44%. Pelvic floor physical therapy (PFPT) is a therapeutic strategy with low cost and risk to patients used to treat SUI following prostate surgery. However, data on the efficacy of conducting PFPT prior to HoLEP in minimizing or eliminating post-operative urinary incontinence is limited. The investigators will recruit patients who have already agreed to undergo HoLEP for this study. Participants will be randomized into two groups: The intervention group will begin standardized PFPT before surgery and will continue PFPT after surgery, and the second group will begin PFPT after surgery only (current practice). Both groups will continue with PFPT following surgery until urinary continence is regained. Investigators will compare the time required to regain urinary continence and patient-reported outcomes between the two groups.
Conditions Studied
Interventions
- BEHAVIORAL Pelvic floor physical therapy
Study Locations (1)
California
- University of California Irvine Medical Center - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-02-08 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06209307
The ClinicalTrials.gov registry entry for NCT06209307 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 161-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (55% lower). The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Pelvic floor physical therapy is the first listed.
NCT06209307 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06209307 about?
NCT06209307 is a clinical study titled "Pelvic Floor Physical Therapy to Reduce Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate". Holmium laser enucleation of the prostate (HoLEP) is a surgical procedure used to treat benign prostatic hyperplasia (BPH). HoLEP involves the removal of obstructive prostatic tissue via an endoscopic approach to relieve bothersome urinary symptoms. HoLEP is recommended by the American Urological As...
What is the current status of trial NCT06209307?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2024-02-08. Estimated completion is 2026-05-31.
What conditions does trial NCT06209307 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence, Prostatic Hyperplasia.
What interventions are being tested in trial NCT06209307?
The interventions under investigation include: Pelvic floor physical therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT06209307?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06209307 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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