Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05719220

Effect of Group Preoperative Pelvic Floor Training for HoLEP

The Effect of Group Preoperative Pelvic Floor Training on Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate: A Prospective Cohort Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
University of California, San Francisco · Academic / Other
Sex
Male
Age
50 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGroup preoperative pelvic floor trainingPatients will receive PFT from a trained physical therapist delivered in a group setting of 8-10 people. The investigators allow patients in the PFT group to attend group classes as many times as they want prior to surgery to see if the frequency of training has an effect on outcomes. The treatment group could be required to go to at least 1 group class 4 weeks prior to their procedure, but they could be welcome to attend more if they want further practice and review of the material. A 45-minute group class with basic PFT guidelines could be presented weekly during the study.

Timeline

Start date
2024-02-07
Primary completion
2025-12-31
Completion
2026-03-30
First posted
2023-02-08
Last updated
2025-01-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05719220. Inclusion in this directory is not an endorsement.