Clinical trial NCT06179654: Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Official title: Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia With Outflow Obstruction
Urinary Retention
Lower Urinary Tract Symptoms
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-cohort study. Group A will start pelvic floor exercises before surgery and Group B will start exercises after surgery.
Primary purpose: PREVENTION

Brief 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.

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to continence
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Uroflow
timeFrame: 6 months after surgery
measure: Post void residual
timeFrame: 6 months after surgery
measure: international prostate symptom score
timeFrame: 6 months after surgery
measure: operative time
timeFrame: day of surgery
measure: length of stay
timeFrame: 30 days after surgery
measure: catheter duration
timeFrame: 30 days after surgery
measure: infectious complications
timeFrame: 30 days after surgery
measure: emergency room visits
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References: