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Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence

Primary Purpose

Prostate Neoplasm, Prostatectomy, Surgical Procedures, Robotic

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Extracorporeal biofeedback device (Any Kegel)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Neoplasm focused on measuring Prostate cancer, Robot-assisted laparoscopic surgery, Radical prostatectomy, Post-prostatectomy incontinence, Pelvic floor muscle exercise, Extracorporeal biofeedback device

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Kegel exercise education

Extracorporeal biofeedback device

Arm 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.

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.

Outcomes

Primary Outcome Measures

Recovery of urinary continence
weight of pad (g) by 24 hours pad test

Secondary Outcome Measures

Recovery of urinary continence
weight of pad (g) by 24 hours pad test
Recovery of urinary continence
number of pads for 24 hours

Full Information

First Posted
June 26, 2015
Last Updated
November 16, 2015
Sponsor
Seoul National University Hospital
Collaborators
Furun Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02485665
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Furun Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kegel exercise education
Arm Type
No Intervention
Arm 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.
Arm Title
Extracorporeal biofeedback device
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Extracorporeal biofeedback device (Any Kegel)
Intervention 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. 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)
Primary Outcome Measure Information:
Title
Recovery of urinary continence
Description
weight of pad (g) by 24 hours pad test
Time Frame
postoperative 1 month
Secondary Outcome Measure Information:
Title
Recovery of urinary continence
Description
weight of pad (g) by 24 hours pad test
Time Frame
postoperative 3 month
Title
Recovery of urinary continence
Description
number of pads for 24 hours
Time Frame
postoperative 1 and 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minyong Kang, M.D.,Ph.D.
Phone
82-31-787-6631
Email
dr.minyong.kang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dam-on Lee
Phone
82-31-787-7350
Email
r1453@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok-Soo Byun, M.D.,Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongam city
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seok-Soo Byun, M.D.,Ph.D.
Phone
031-787-7342
Email
ssbyun@snubh.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
31793032
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.
Results Reference
derived

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Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence

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