Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence

November 16, 2015 updated by: Seok-Soo Byun, Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongam city, Gyeonggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Kegel exercise education
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.
Experimental: Extracorporeal biofeedback device
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.
Device: Extracorporeal 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of urinary continence
Time Frame: postoperative 1 month
weight of pad (g) by 24 hours pad test
postoperative 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of urinary continence
Time Frame: postoperative 3 month
weight of pad (g) by 24 hours pad test
postoperative 3 month
Recovery of urinary continence
Time Frame: postoperative 1 and 3 months
number of pads for 24 hours
postoperative 1 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Furun Medical

Investigators

  • Principal Investigator: Seok-Soo Byun, M.D.,Ph.D., Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-2015-298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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