RecruitingNot Applicable

Effect of Group Preoperative Pelvic Floor Training for HoLEP

United States100 participantsStarted 2024-02-07

Plain-language 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.

Who can participate

Age range

50 Years – 90 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of urinary incontinence at 1 month

Timeframe: 1 month after the operation

Incidence of urinary incontinence at 3 months

Timeframe: 3 months after the operation

Trial details

NCT IDNCT05719220

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-01

Contact for this trial

Victoria Hogue

415-302-7443 victoria.hogue@ucsf.edu

View on ClinicalTrials.gov More BPH trials