Biofeedback, Exercise, Pelvic Floor, Prostatectomy, Prostate Neoplasm, Surgical Procedures, Robotic, Urinary Incontinence
Conditions
Keywords
Prostate cancer, Robot-assisted laparoscopic surgery, Radical prostatectomy, Post-prostatectomy incontinence, Pelvic floor muscle exercise, Extracorporeal biofeedback device
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.
Interventions
DEVICEExtracorporeal 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)
Sponsors
Furun Medical
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of urinary continence | postoperative 1 month | weight of pad (g) by 24 hours pad test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of urinary continence | postoperative 3 month | weight of pad (g) by 24 hours pad test |
Countries
South Korea
Contacts
Primary ContactMinyong Kang, M.D.,Ph.D.
Backup ContactDam-on Lee
Outcome results
None listed