- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06209307
Pelvic Floor Physical Therapy to Reduce Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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California
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Orange, California, United States, 92868
- University of California Irvine Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Pelvic floor physical therapy (i.e., Kegel exercises):
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to urinary continence following catheter removal after HoLEP
Time Frame: 6 months after surgery
|
Time to recover from transient postoperative stress urinary incontinence
|
6 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post void residual
Time Frame: 6 months after surgery
|
Residual urine after voiding (milliliters)
|
6 months after surgery
|
Uroflow
Time Frame: 6 months after surgery
|
Urine flow rate (milliliters/second)
|
6 months after surgery
|
American Urological Association Symptom Score
Time Frame: 6 months after surgery
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Validated questionnaire on urination symptoms
|
6 months after surgery
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Operative time
Time Frame: Day of surgery
|
Length of surgery (minutes)
|
Day of surgery
|
Length of hospital stay
Time Frame: 30 days after surgery
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Days of hospitalization after surgery
|
30 days after surgery
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Catheter duration
Time Frame: 30 days after surgery
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Days with catheter after surgery
|
30 days after surgery
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Infectious complications
Time Frame: 30 days after surgery
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Urinary tract infection complication after surgery
|
30 days after surgery
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Emergency room visits
Time Frame: 30 days after surgery
|
Number of emergency room visits related to surgery
|
30 days after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Akhil Das, MD, University of California, Irvine
Publications and helpful links
General Publications
- 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.
- Roehrborn CG. Benign prostatic hyperplasia: an overview. Rev Urol. 2005;7 Suppl 9(Suppl 9):S3-S14.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Prostatic Diseases
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Urinary Incontinence
- Prostatic Hyperplasia
- Hyperplasia
- Enuresis
- Urinary Incontinence, Stress
Other Study ID Numbers
- 3574
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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