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Efficacy and Safety of Extracorporeal Biofeedback

This study has been completed.
Sponsor:
Collaborator:
Furun Medical
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00910338
First received: May 28, 2009
Last updated: April 21, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Female Stress Urinary Incontinence
 Device: PFMT with Extracorporeal Biofeedback

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Extracorporeal Biofeedback Pelvic Floor Muscle Training to Treat Urodynamic Stress Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW). [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2007
Study Completion Date: December 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: HnJ-5300

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910338

Locations
Korea, Republic of
Samsung Medical Center
50 Ilwon-Dong, Gangnam-Gu, Seoul, Korea, Republic of, 135-710
Asan Medical Center, Ulsan College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Furun Medical
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00910338     History of Changes
Other Study ID Numbers: 2007-06-075
Study First Received: May 28, 2009
Last Updated: April 21, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
Pelvic Floor Muscle Training
Extracorporeal Biofeedback

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013