Clinical trial NCT05719220: Effect of Group Preoperative Pelvic Floor Training for HoLEP
Official title: The Effect of Group Preoperative Pelvic Floor Training on Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: BPH
Urinary Incontinence
Keywords: benign prostatic hyperplasia
pelvic floor training
group therapy
holmium laser enucleation of the prostate
urinary incontinence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators will recruit a cohort of patients scheduled to undergo HoLEP at the UCSF Urology Clinic. Well-informed consent will be obtained from every patient after giving balanced information about the options of group preoperative PFT and no training before recruitment in the study. The investigators will offer the group class to everyone and use the patients who decline the group class as the control group (N = 50: 50 each arm).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of urinary incontinence at 1 month
timeFrame: 1 month after the operation
measure: Incidence of urinary incontinence at 3 months
timeFrame: 3 months after the operation
Secondary outcomes:
measure: The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 1 month
timeFrame: 1 month after the operation
measure: The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 3 months
timeFrame: 3 months after the operation
measure: The International Prostate Symptom Score at 1 month
timeFrame: 1 month after the operation
measure: The International Prostate Symptom Score at 3 months
timeFrame: 3 months after the operation
measure: Pelvic floor muscle strength at 1 month
timeFrame: 1 month after the operation
measure: Pelvic floor muscle strength at 3 months
timeFrame: 3 months after the operation
measure: Patient satisfaction
timeFrame: Immediately after the completion of the PFT program or soon thereafter
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Chi, M.D.
role: PRINCIPAL_INVESTIGATOR
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