Effect of Group Preoperative Pelvic Floor Training for HoLEP

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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BPH, Urinary Incontinence

Intervention / Treatment
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* Behavioral: Group preoperative pelvic floor training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group preoperative pelvic floor training<br>Patients will receive group preoperative PFT, 4 weeks prior to HoLEP. | Behavioral: Group preoperative pelvic floor training<br>* 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.<br>|
| No preoperative pelvic floor training<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Immediately after the completion of the PFT program or soon thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign prostatic hyperplasia, pelvic floor training, group therapy, holmium laser enucleation of the prostate, urinary incontinence