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Clinical Trials/NCT05719220
NCT05719220
Recruiting
N/A

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

University of California, San Francisco1 site in 1 country100 target enrollmentFebruary 7, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
BPH
Sponsor
University of California, San Francisco
Enrollment
100
Locations
1
Primary Endpoint
Incidence of urinary incontinence at 1 month
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 7, 2024
End Date
March 30, 2026
Last Updated
last year
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Consecutive patients with a diagnosis of BPH with a plan to undergo HoLEP.
  • Between the age of 50-
  • 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.

Outcomes

Primary Outcomes

Incidence of urinary incontinence at 1 month

Time Frame: 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

Time Frame: 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 Outcomes

  • The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 1 month(1 month after the operation)
  • Pelvic floor muscle strength at 3 months(3 months after the operation)
  • Patient satisfaction(Immediately after the completion of the PFT program or soon thereafter)
  • The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 3 months(3 months after the operation)
  • The International Prostate Symptom Score at 1 month(1 month after the operation)
  • The International Prostate Symptom Score at 3 months(3 months after the operation)
  • Pelvic floor muscle strength at 1 month(1 month after the operation)

Study Sites (1)

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