An observational study in BPH and Urinary Incontinence, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to male participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by University of California, San Francisco · Observational
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.
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 215 observational studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive group preoperative PFT, 4 weeks prior to HoLEP.
Behavioral: Group preoperative pelvic floor training
The control group will receive standard care, which may include patient education about postoperative care and pelvic floor muscle exercises, but will not receive structured group PFT.
Patients 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.
Incidence of urinary incontinence at 1 month
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.
Time frame: 1 month after the operation
Incidence of urinary incontinence at 3 months
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.
Time frame: 3 months after the operation
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 1 month
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.
Time frame: 1 month after the operation
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 3 months
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.
Time frame: 3 months after the operation
The International Prostate Symptom Score at 1 month
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.
Time frame: 1 month after the operation
The International Prostate Symptom Score at 3 months
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.
Time frame: 3 months after the operation
Pelvic floor muscle strength at 1 month
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.
Time frame: 1 month after the operation
Pelvic floor muscle strength at 3 months
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.
Time frame: 3 months after the operation
Patient satisfaction
Patient satisfaction after receiving group PFT will be evaluated using a patient satisfaction with outpatient physical therapy survey.
Time frame: Immediately after the completion of the PFT program or soon thereafter
Plan to share: No
Started Feb 2024 (actual). Primary completion is estimated for Dec 2028, 57 months after the start.
Of 66 non-industry observational studies under Urinary Incontinence, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 50. This study's planned 57 months is above that.
Counting every sponsor, half of 74 studies reached it within 35 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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