Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence

Seoul National University

Status: Unknown

Conditions: Pelvic Floor; Prostatectomy; Prostate Neoplasm; Surgical Procedures, Robotic; Exercise; Urinary Incontinence; Biofeedback

Treatments: Device: Extracorporeal biofeedback device (Any Kegel)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02485665

L-2015-298

Details and patient eligibility

About

To evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence

Full 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.

Enrollment: 84 estimated patients

Sex: Male

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Kegel exercise education

No Intervention group

Description:

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.

Extracorporeal biofeedback device

Experimental group

Description:

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.

Treatment:

Device: Extracorporeal biofeedback device (Any Kegel)