Effect of Group Preoperative Pelvic Floor Training for HoLEP

Recruiting

• Conditions: BPH; Urinary Incontinence
• Interventions: Behavioral: Group preoperative pelvic floor training

• Registration Number: NCT05719220
• Lead Sponsor: University of California, San Francisco

Brief Summary

The main goal of this study is to see if group pelvic floor training before surgery can help prevent urinary incontinence after Holmium laser enucleation of the prostate (HoLEP) surgery. The study has the potential to inform preoperative intervention strategies for managing incontinence after HoLEP.

Detailed Description

Preoperative pelvic floor training (PFT) may improve early urinary incontinence after prostate surgery. Group-based training potentially provides additional benefits such as cost-benefit, social support, and motivation. However, the efficacy of group preoperative PFT has not been reported. This study aims to determine the effect of group preoperative PFT on transient urinary incontinence after HoLEP in a prospective cohort of patients and to identify any potential predictors of transient urinary incontinence after HoLEP.

In this study, the investigators will recruit approximately 50 patients in each cohort (total 100) and will be followed over time to collect data on both the exposure (group PFT) and the outcome (incidence of urinary incontinence 1 month and 3 months after HoLEP). Potential confounding variables, such as patient demographics, preoperative imaging, and operative data, will be collected and analyzed. The results of this study have the potential to inform the development of effective preoperative interventions for the management of transient urinary incontinence after HoLEP.

Study Timeline

• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-08
• Study Start: 2024-02-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Consecutive patients with a diagnosis of BPH with a plan to undergo HoLEP.
• Between the age of 50-90.
• Ability to understand and provide informed consent.

Exclusion Criteria

• Patients whom inability to carry out PFT protocol.
• Patients unwilling or unable to complete follow up care.
• Severe urinary incontinence due to a history of neurological diseases such as a cerebrovascular accident or spinal cord injuries.
• Patients whom inability to read and understand the English language.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group preoperative pelvic floor training	Group preoperative pelvic floor training	Patients will receive group preoperative PFT, 4 weeks prior to HoLEP.

Primary Outcome Measures

Name	Time	Method
Incidence of urinary incontinence at 1 month	1 month after the operation	Urinary incontinence (present/absent) will be defined according to the guidelines of the International Continence Society as involuntary loss of urine experienced during the bladder storage phase using self-report measures at regular intervals postoperatively.
Incidence of urinary incontinence at 3 months	3 months after the operation	Urinary incontinence (present/absent) will be defined according to the guidelines of the International Continence Society as involuntary loss of urine experienced during the bladder storage phase using self-report measures at regular intervals postoperatively.

Secondary Outcome Measures

Name	Time	Method
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 1 month	1 month after the operation	The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a self-administered questionnaire used to measure the severity of urinary incontinence symptoms, such as frequency, urgency, and amount of urine loss, as well as the impact of urinary incontinence on daily activities and emotional well-being. The total score ranges from 0 to 21, with higher scores indicating more severe urinary incontinence and greater impact on quality of life.
Pelvic floor muscle strength at 3 months	3 months after the operation	Preoperative and postoperative pelvic floor muscle strength measured by perineometer (the output in cmH2O) will be compared to determine whether the strength gain or maintenance, which could be a repeated measure at baseline, 1 month, and 3 months.
Patient satisfaction	Immediately after the completion of the PFT program or soon thereafter	Patient satisfaction after receiving group PFT will be evaluated using a patient satisfaction with outpatient physical therapy survey.
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 3 months	3 months after the operation	The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a self-administered questionnaire used to measure the severity of urinary incontinence symptoms, such as frequency, urgency, and amount of urine loss, as well as the impact of urinary incontinence on daily activities and emotional well-being. The total score ranges from 0 to 21, with higher scores indicating more severe urinary incontinence and greater impact on quality of life.
The International Prostate Symptom Score at 1 month	1 month after the operation	The International Prostate Symptom Score (IPSS) is a self-administered questionnaire that assesses the severity of lower urinary tract symptoms (LUTS) in men. The questionnaire consists of 7 items that assess symptoms such as frequency, urgency, nocturia, weak stream, straining, incomplete emptying, and terminal dribbling. Each item is scored on a scale of 0-5. The total score ranges from 0 to 35, with higher scores indicating more severe symptoms and the last question for measuring the effect of LUTS on quality of life.
The International Prostate Symptom Score at 3 months	3 months after the operation	The International Prostate Symptom Score (IPSS) is a self-administered questionnaire that assesses the severity of lower urinary tract symptoms (LUTS) in men. The questionnaire consists of 7 items that assess symptoms such as frequency, urgency, nocturia, weak stream, straining, incomplete emptying, and terminal dribbling. Each item is scored on a scale of 0-5. The total score ranges from 0 to 35, with higher scores indicating more severe symptoms and the last question for measuring the effect of LUTS on quality of life.
Pelvic floor muscle strength at 1 month	1 month after the operation	Preoperative and postoperative pelvic floor muscle strength measured by perineometer (the output in cmH2O) will be compared to determine whether the strength gain or maintenance, which could be a repeated measure at baseline, 1 month, and 3 months.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States