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

NCT06209307 | Active Not Recruiting

• 1 other identifier: 3574
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Hyperplasia; Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Time to urinary continence following catheter removal after HoLEP

  Time to recover from transient postoperative stress urinary incontinence

  6 months after surgery

Secondary Outcomes (8)

• Uroflow

  6 months after surgery

• Post void residual

  6 months after surgery

• American Urological Association Symptom Score

  6 months after surgery

• Operative time

  Day of surgery

• Length of hospital stay

  30 days after surgery

Study Arms (2)

Arm 1: Preoperative and postoperative pelvic floor physical therapy

EXPERIMENTAL

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

Behavioral: Pelvic floor physical therapy

Arm 2: Postoperative pelvic floor physical therapy only.

NO INTERVENTION

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.

Interventions

Pelvic floor physical therapy 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 1: Preoperative and postoperative pelvic floor physical therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male patients will be recruited as physiologically only male patients have prostate and can develop LUTS/BPH.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (11)

• Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.

  PMID: 1279218 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Montorsi F, Naspro R, Salonia A, Suardi N, Briganti A, Zanoni M, Valenti S, Vavassori I, Rigatti P. Holmium laser enucleation versus transurethral resection of the prostate: results from a 2-center prospective randomized trial in patients with obstructive benign prostatic hyperplasia. J Urol. 2008 May;179(5 Suppl):S87-90. doi: 10.1016/j.juro.2008.03.143.

  PMID: 18405765 BACKGROUND

• Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol. 2005;7 Suppl 9(Suppl 9):S3-S14.

  PMID: 16985902 BACKGROUND

• Michalak J, Tzou D, Funk J. HoLEP: the gold standard for the surgical management of BPH in the 21(st) Century. Am J Clin Exp Urol. 2015 Apr 25;3(1):36-42. eCollection 2015.

  PMID: 26069886 BACKGROUND

• Das AK, Teplitsky S, Chandrasekar T, Perez T, Guo J, Leong JY, Shenot PJ. Stress Urinary Incontinence post-Holmium Laser Enucleation of the Prostate: a Single-Surgeon Experience. Int Braz J Urol. 2020 Jul-Aug;46(4):624-631. doi: 10.1590/S1677-5538.IBJU.2019.0411.

  PMID: 32374125 BACKGROUND

• Han E, Black LK, Lavelle JP. Incontinence related to management of benign prostatic hypertrophy. Am J Geriatr Pharmacother. 2007 Dec;5(4):324-34. doi: 10.1016/j.amjopharm.2007.12.003.

  PMID: 18179990 BACKGROUND

• Hout M, Gurayah A, Arbelaez MCS, Blachman-Braun R, Shah K, Herrmann TRW, Shah HN. Incidence and risk factors for postoperative urinary incontinence after various prostate enucleation procedures: systemic review and meta-analysis of PubMed literature from 2000 to 2021. World J Urol. 2022 Nov;40(11):2731-2745. doi: 10.1007/s00345-022-04174-1. Epub 2022 Oct 4.

  PMID: 36194286 BACKGROUND

• Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1.

  PMID: 20227168 BACKGROUND

• Anan G, Kaiho Y, Iwamura H, Ito J, Kohada Y, Mikami J, Sato M. Preoperative pelvic floor muscle exercise for early continence after holmium laser enucleation of the prostate: a randomized controlled study. BMC Urol. 2020 Jan 23;20(1):3. doi: 10.1186/s12894-019-0570-5.

  PMID: 31973706 BACKGROUND

• Moore KN, Cody DJ, Glazener CM. Conservative management for post prostatectomy urinary incontinence. Cochrane Database Syst Rev. 2001;(2):CD001843. doi: 10.1002/14651858.CD001843.

  PMID: 11406013 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Akhil Das, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FACS, Professor of Clinical Urology

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 17, 2024
• Study Start: February 8, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)