Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence
- Conditions
- ProstatectomySurgical Procedures, RoboticUrinary IncontinencePelvic FloorProstate NeoplasmBiofeedbackExercise
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Seoul National University Bundang Hospital🇰🇷Seongam city, Gyeonggi-do, Korea, Republic ofSeok-Soo Byun, M.D.,Ph.D.Contact031-787-7342ssbyun@snubh.org