Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence

Study Overview
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Brief Summary
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To evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence

Detailed Description
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Post prostatectomy urinary incontinence (PPI) was common complication after radical prostatectomy among prostate cancer patients. The prevalence of post-prostatectomy urinary incontinence was reported at 87%. The pelvic floor muscle therapy (PFMT) using Kegel exercise was first methods to prevent PPI after prostatectomy. However, there was no standardized protocol of the PFMT and it was necessary of biofeedback to PFMT. Therefore, we hypothesis the efficacy of personalized device of PFMT with biofeedback among patients who underwent radical prostatectomy In this study, we evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence.

Official Title
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Efficacy of Personalized Extracorporeal Biofeedback Device for Pelvic Floor Muscle Training on Post-prostatectomy Incontinence

Conditions
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Prostate Neoplasm, Prostatectomy, Surgical Procedures, Robotic, Urinary Incontinence, Biofeedback, Pelvic Floor, Exercise

Intervention / Treatment
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* Device: Extracorporeal biofeedback device (Any Kegel)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate cancer patients who underwent robotic radical prostatectomy Neurovascular saving at least one side Bladder neck reconstruction at prostatectomy Posterior reconstruction at prostatectomy Patients who have post-prostatectomy incontinence after Foley catheter removal Exclusion Criteria: Patients who have not post-prostatectomy incontinence after Foley catheter removal Neurological deficits Anatomic deformities of pelvic bone Pelvic irradiation history History of other major urological procedures Complications influencing urinary incontinence

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Kegel exercise education<br>Prostate cancer patients of control group will received Kegel exercise education for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. | |
| Experimental: Extracorporeal biofeedback device<br>Prostate cancer patients of intervention group will received extracorporeal biofeedback device (Any Kegel) for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. | Device: Extracorporeal biofeedback device (Any Kegel)<br>* Prostate cancer patients of intervention group will received extracorporeal biofeedback device (Any Kegel) for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. Enrolled patients in intervention group should be performed PFME regularly, based on following protocols: total exercise time (10 minutes/day), intensity (1.2 kgf), tension duration (10 sec/ 1 contraction), total exercise number (4 times/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of urinary continence | weight of pad (g) by 24 hours pad test | postoperative 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of urinary continence | weight of pad (g) by 24 hours pad test | postoperative 3 month | 
| Recovery of urinary continence | number of pads for 24 hours | postoperative 1 and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Robot-assisted laparoscopic surgery, Radical prostatectomy, Post-prostatectomy incontinence, Pelvic floor muscle exercise, Extracorporeal biofeedback device