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Efficacy and Safety of Extracorporeal Biofeedback

Primary Purpose

Female Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PFMT with Extracorporeal Biofeedback
Sponsored by
KYU-SUNG LEE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Stress Urinary Incontinence focused on measuring Pelvic Floor Muscle Training, Extracorporeal Biofeedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with stress urinary incontinence
  • Standard pad test > 2gram

Exclusion Criteria:

Women with:

  • Mixed urinary incontinence of which urgency incontinence is dominant
  • True incontinence
  • Overflow incontinence
  • Treatment within 14 days preceding screening, or expected to initiate treatment during the study with electrostimulation, bladder training
  • Treatment within 7 days preceding screening, or expected to initiate treatment during the study with OAB medication or other medication which affect bladder function
  • Pelvic organ prolapse which the stage is at least 2
  • Proven urinary tract infection during screening period
  • Pacemaker
  • Pregnant women
  • Neurogenic voiding dysfunction

Sites / Locations

  • Samsung Medical Center
  • Asan Medical Center, Ulsan College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PFMT with Extracorporeal Biobeedback

Arm Description

Outcomes

Primary Outcome Measures

Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test.

Secondary Outcome Measures

Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength.
Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW).

Full Information

First Posted
May 28, 2009
Last Updated
November 28, 2019
Sponsor
KYU-SUNG LEE
Collaborators
Furun Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00910338
Brief Title
Efficacy and Safety of Extracorporeal Biofeedback
Official Title
Efficacy and Safety of Extracorporeal Biofeedback Pelvic Floor Muscle Training to Treat Urodynamic Stress Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
KYU-SUNG LEE
Collaborators
Furun Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal probe is one of the limitation. So, the purpose of this study is to assess the efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Stress Urinary Incontinence
Keywords
Pelvic Floor Muscle Training, Extracorporeal Biofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PFMT with Extracorporeal Biobeedback
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PFMT with Extracorporeal Biofeedback
Other Intervention Name(s)
HnJ-5300
Intervention Description
Pelvic Floor Muscle Training with Extracorporeal Biofeedback Device for 12 weeks Twice a week for the first 4 weeks Once a week for the next 8 weeks
Primary Outcome Measure Information:
Title
Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test.
Time Frame
After 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength.
Time Frame
After 12 weeks of treatment
Title
Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW).
Time Frame
After 12 weeks of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with stress urinary incontinence Standard pad test > 2gram Exclusion Criteria: Women with: Mixed urinary incontinence of which urgency incontinence is dominant True incontinence Overflow incontinence Treatment within 14 days preceding screening, or expected to initiate treatment during the study with electrostimulation, bladder training Treatment within 7 days preceding screening, or expected to initiate treatment during the study with OAB medication or other medication which affect bladder function Pelvic organ prolapse which the stage is at least 2 Proven urinary tract infection during screening period Pacemaker Pregnant women Neurogenic voiding dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Irwon-dong
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center, Ulsan College of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy and Safety of Extracorporeal Biofeedback

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