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NCT Number: NCT05719220

Effect of Group Preoperative Pelvic Floor Training for HoLEP

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.

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Key information

Conditions

BPH Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Max Bowman, MD

PRINCIPAL_INVESTIGATOR

Victoria Hogue

CONTACT

[email protected]

415-302-7443

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group preoperative pelvic floor training

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 1 month

    Time frame: 1 month after the operation

    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.

  2. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 3 months

    Time frame: 3 months after the operation

    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.

  3. The International Prostate Symptom Score at 1 month

    Time frame: 1 month after the operation

    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.

  4. The International Prostate Symptom Score at 3 months

    Time frame: 3 months after the operation

    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.

  5. Pelvic floor muscle strength at 1 month

    Time frame: 1 month after the operation

    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.

  6. Pelvic floor muscle strength at 3 months

    Time frame: 3 months after the operation

    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.

  7. Patient satisfaction

    Time frame: Immediately after the completion of the PFT program or soon thereafter

    Patient satisfaction after receiving group PFT will be evaluated using a patient satisfaction with outpatient physical therapy survey.

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria Hogue

CONTACT

[email protected]

415-302-7443

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 8, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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