Clinical trial NCT02485665: Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence
Official title: Efficacy of Personalized Extracorporeal Biofeedback Device for Pelvic Floor Muscle Training on Post-prostatectomy Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Neoplasm
Prostatectomy
Surgical Procedures, Robotic
Urinary Incontinence
Biofeedback
Pelvic Floor
Exercise
Keywords: Prostate cancer
Robot-assisted laparoscopic surgery
Radical prostatectomy
Post-prostatectomy incontinence
Pelvic floor muscle exercise
Extracorporeal biofeedback device
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Furun Medical
First posted: 2015-06-30
Enrollment: 84
Sex: MALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recovery of urinary continence
timeFrame: postoperative 1 month
Secondary outcomes:
measure: Recovery of urinary continence
timeFrame: postoperative 3 month
measure: Recovery of urinary continence
timeFrame: postoperative 1 and 3 months
Other outcomes:
Locations:
city: Seongam city
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Seok-Soo Byun, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.