Pelvic Floor Physical Therapy to Reduce Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate

NCT ID: NCT06209307

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-08
• Study Completion Date: 2026-05-31

Brief 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.

Detailed Description

The incidence of benign prostatic hyperplasia (BPH) in men significantly increases with age and is estimated to impact over 80% of men 70 to 80 years of age. HoLEP is one of many treatments for BPH and associated lower urinary tract symptoms (LUTS). Compared to other minimally invasive surgical techniques for the treatment of BPH, HoLEP has been found to have superior outcomes and is a prostate size-independent procedure with excellent durability, high efficacy, and low complication rates. However, transient stress urinary incontinence (SUI) following HoLEP may last for several months after surgery and can lead to diminished patient quality of life (QoL) during the recovery period. Measures to prevent or reduce post-operative SUI following HoLEP, including PFPT, may improve patient outcomes.

SUI is also commonly documented after radical prostatectomy (RP) for prostate cancer. The mechanism for incontinence in both RP and HoLEP is thought to at least partially be related to temporary weakness of the external urinary sphincter, which is part of the pelvic floor musculature. While it is unclear if post-operative PFPT alone reduces SUI for patients who have undergone RP, there is evidence that PFPT started pre-operatively and continued post-operatively can decrease SUI following RP.

The utilization of pre-operative PFPT for patients undergoing HoLEP to reduce post-operative SUI is currently not well documented. To date, only one study has demonstrated evidence that PFPT prior to HoLEP may improve continence at 3 months. However, the study included patients with a BMI significantly lower than average in the United States, utilized an unclear PFPT program, and had a relatively small median prostate size (~60 mL), which is important as studies have shown that prostate size can affect post-operative incontinence.

Investigators propose a prospective randomized trial to investigate the efficacy of standardized pre-operative PFPT in reducing SUI and improving patient QoL following HoLEP. This study will help determine the role of pre-operative PFPT in the management of HoLEP-associated SUI.

Conditions

Prostatic Hyperplasia; Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Preoperative and postoperative pelvic floor physical therapy

Pelvic floor physical therapy (PFPT) will be initiated 1 month before surgery in patients randomized to Arm 1.

Group Type: EXPERIMENTAL

Pelvic floor physical therapy

Intervention Type: BEHAVIORAL

Pelvic floor physical therapy (i.e., Kegel exercises):

• Finding the right muscles: To identify pelvic floor muscles, the patient should stop urination in midstream or tighten the muscles that keep from passing gas. These maneuvers use pelvic floor muscles. Once the pelvic floor muscles are identified, the patient can do the exercises in any position, although doing them lying down at first might be the easiest approach.
• Perfecting the technique: Tighten pelvic floor muscles, hold the contraction for three seconds, and then relax for three seconds. Try it a few times in a row. When muscles get stronger, try doing Kegel exercises while sitting, standing, or walking.
• Maintaining focus: For best results, focus on tightening only pelvic floor muscles. Be careful not to flex the muscles in the abdomen, thighs, or buttocks. Avoid breath-holding. Instead, breathe freely during the exercises.
• Repeat 3 times a day. Aim for three sets of 10 repetitions a day.

Arm 2: Postoperative pelvic floor physical therapy only.

At 1-3 days follow-up after surgery pelvic floor physical therapy (PFPT) will be initiated in the post-operative PFPT-only group as part of standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pelvic floor physical therapy

Pelvic floor physical therapy (i.e., Kegel exercises):

• Finding the right muscles: To identify pelvic floor muscles, the patient should stop urination in midstream or tighten the muscles that keep from passing gas. These maneuvers use pelvic floor muscles. Once the pelvic floor muscles are identified, the patient can do the exercises in any position, although doing them lying down at first might be the easiest approach.
• Perfecting the technique: Tighten pelvic floor muscles, hold the contraction for three seconds, and then relax for three seconds. Try it a few times in a row. When muscles get stronger, try doing Kegel exercises while sitting, standing, or walking.
• Maintaining focus: For best results, focus on tightening only pelvic floor muscles. Be careful not to flex the muscles in the abdomen, thighs, or buttocks. Avoid breath-holding. Instead, breathe freely during the exercises.
• Repeat 3 times a day. Aim for three sets of 10 repetitions a day.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult males who have lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) and considering/undergoing HoLEP for LUTS/BPH treatment at the University of California Irvine Medical Center.
• Age >= 18
• English-speaker

Exclusion Criteria

• Non-English speaker
• Having an indwelling catheter preoperatively
• Neurological disorders that might potentially affect muscle function
• Neurogenic bladder
• Lumbosacral spine pathology
• Any condition that can interfere with pelvic muscle function per principal investigator's discretion

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Akhil Das

MD, FACS, Professor of Clinical Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akhil Das, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California Irvine Medical Center

Orange, California, United States

Countries

United States

References

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Other Identifiers

3574

Identifier Type: -

Identifier Source: org_study_id