Clinical Trials Directory

Trials / Unknown

UnknownNCT02485665

Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence

Efficacy of Personalized Extracorporeal Biofeedback Device for Pelvic Floor Muscle Training on Post-prostatectomy Incontinence

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
84 (estimated)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
Male
Age
20 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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)

Timeline

Start date
2015-07-01
Primary completion
2016-03-01
Completion
2016-07-01
First posted
2015-06-30
Last updated
2015-11-18

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02485665. Inclusion in this directory is not an endorsement.