Efficacy and Safety of Extracorporeal Biofeedback

Efficacy and Safety of Extracorporeal Biofeedback Pelvic Floor Muscle Training to Treat Urodynamic Stress Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Female Stress Urinary Incontinence
• Intervention / Treatment: Device: PFMT with Extracorporeal Biofeedback

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Irwon-dong, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Asan Medical Center, Ulsan College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PFMT with Extracorporeal Biobeedback	Device: PFMT with Extracorporeal Biofeedback; 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; Other Names: HnJ-5300

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test.	After 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength.	After 12 weeks of treatment
Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW).	After 12 weeks of treatment

Collaborators and Investigators

• Sponsor: KYU-SUNG LEE
• Collaborators: Furun Medical

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): May 29, 2009

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Pelvic Floor Muscle Training; Extracorporeal Biofeedback
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 2007-06-075