Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence

Not Applicable

• Conditions: Prostatectomy; Surgical Procedures, Robotic; Urinary Incontinence; Pelvic Floor; Prostate Neoplasm; Biofeedback; Exercise
• Interventions: Device: Extracorporeal biofeedback device (Any Kegel)

• Registration Number: NCT02485665
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

* 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.

Study Timeline

• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-06-30
• Study Start: 2015-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-18
• Primary Completion: 2016-03
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 84

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extracorporeal biofeedback device	Extracorporeal biofeedback device (Any Kegel)	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.

Primary Outcome Measures

Name	Time	Method
Recovery of urinary continence	postoperative 1 month	weight of pad (g) by 24 hours pad test

Secondary Outcome Measures

Name	Time	Method
Recovery of urinary continence	postoperative 1 and 3 months	number of pads for 24 hours

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongam city, Gyeonggi-do, Korea, Republic of