Effect of Group Preoperative Pelvic Floor Training for HoLEP
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age50-90
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Group preoperative pelvic floor training
BehavioralPatients 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group preoperative pelvic floor training1 intervention
Group B: No preoperative pelvic floor training0 interventions
Trial outcomes
Primary outcomes
1
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 operation2
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 operationSecondary outcomes
1
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 operation2
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 operation3
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 operation4
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 operationSponsors and contacts
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Source ClinicalTrials.gov