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

Lower Urinary Tract Symptoms 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: Recruiting

Administrative data

• NCT number: NCT06179654
• Other study ID #: 23-1128
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: May 2025

Study information

• Verified date: December 2023
• Source: The Cleveland Clinic
• Contact: Smita De
• Phone: 2163129460
• Email: des[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to allow us to assess the effectiveness (or success) of starting pelvic floor physical therapy (i.e. exercises for your pelvic muscles) prior to HoLEP (holmium laser enucleation of the prostate) surgery for enlarged prostates in order to manage or prevent urinary incontinence (i.e. leaking) after surgery (i.e. post-operatively). Your pelvic floor refers to the muscles under your bladder along your pelvic bones that prevent you from leaking urine or stool. Traditionally, pelvic floor physical therapy is started after surgery and continued until urinary continence (i.e. no leaking of urine) is regained. We want to assess if beginning pelvic floor physical therapy prior to surgery (and continuing afterwards) reduces the time required to regain urinary continence following HoLEP.

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. Compared to other minimally invasive surgical techniques for 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 complications 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 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.

We 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: Recruiting
• Enrollment: 36
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age: >=18 years of age

2. Sex: male sex assigned at birth (needs to have a prostate)

3. BMI: all BMI

4. Ethnic background: all ethnicities

5. Medical history: patients scheduled to undergo HoLEP for BPH/LUTS and associated complications (i.e. gross hematuria, retention, etc.).

Exclusion Criteria:

1. Neurological disorders: patients with a history of a neurologic disorder that could affect muscle function, neurogenic bladder, lumbosacral spine pathology

2. Specific urologic conditions: patients with pre-operative indwelling catheter, urethral stricture greater than 1 centimeter in length or requiring dilation/incision, indwelling ureteral stent

3. History of pelvic radiation: patient with prior pelvic radiation will be excluded

4. Patients unable to give consent

5. Non-English speaking patients given the need for multiple surveys and telephone follow-ups.

Related Conditions & MeSH terms

• Enuresis
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Retention

Intervention

Behavioral:
• Preoperative pelvic floor physical therapy
Pelvic floor physical therapy to start before prostate surgery rather than after surgery.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to continence	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	international prostate symptom score	validated questionnaire on urination symptoms	6 months after surgery
Secondary	operative time	length of surgery (minutes)	day of surgery
Secondary	length of 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