Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence
NCT ID: NCT02485665
Last Updated: 2015-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2015-07-31
2016-07-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Kegel exercise education
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.
No interventions assigned to this group
Extracorporeal biofeedback device
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.
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. 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)
Interventions
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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. 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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Neurological deficits
* Anatomic deformities of pelvic bone
* Pelvic irradiation history
* History of other major urological procedures
* Complications influencing urinary incontinence
20 Years
85 Years
MALE
No
Sponsors
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Furun Medical
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Seok-Soo Byun
Professor
Principal Investigators
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Seok-Soo Byun, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongam City, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Oh JJ, Kim JK, Lee H, Lee S, Jin Jeong S, Kyu Hong S, Eun Lee S, Byun SS. Effect of personalized extracorporeal biofeedback device for pelvic floor muscle training on urinary incontinence after robot-assisted radical prostatectomy: A randomized controlled trial. Neurourol Urodyn. 2020 Feb;39(2):674-681. doi: 10.1002/nau.24247. Epub 2019 Dec 2.
Other Identifiers
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L-2015-298
Identifier Type: -
Identifier Source: org_study_id