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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06209307
• Other study ID #: 3574
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 72
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Hyperplasia
• Prostatic Hyperplasia
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of California Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to urinary continence following catheter removal after HoLEP	Time to recover from transient postoperative stress urinary incontinence	6 months after surgery
Secondary	Uroflow	Urine flow rate (milliliters/second)	6 months after surgery
Secondary	Post void residual	Residual urine after voiding (milliliters)	6 months after surgery
Secondary	American Urological Association Symptom Score	Validated questionnaire on urination symptoms	6 months after surgery
Secondary	Operative time	Length of surgery (minutes)	Day of surgery
Secondary	Length of hospital stay	Days of hospitalization after surgery	30 days after surgery
Secondary	Catheter duration	Days with catheter after surgery	30 days after surgery
Secondary	Infectious complications	Urinary tract infection complication after surgery	30 days after surgery
Secondary	Emergency room visits	Number of emergency room visits related to surgery	30 days after surgery