Efficacy and Safety of Extracorporeal Biofeedback
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2007
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
May 29, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 2, 2019
April 1, 2011
1.7 years
May 28, 2009
November 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
PFMT with Extracorporeal Biobeedback
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Women with stress urinary incontinence
- Standard pad test \> 2gram
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KYU-SUNG LEElead
- Furun Medicalcollaborator
Study Sites (2)
Samsung Medical Center
Irwon-dong, 135-710, South Korea
Asan Medical Center, Ulsan College of Medicine
Seoul, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Kyu-Sung Lee, Ph.D
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 28, 2009
First Posted
May 29, 2009
Study Start
July 1, 2007
Primary Completion
March 1, 2009
Study Completion
December 1, 2009
Last Updated
December 2, 2019
Record last verified: 2011-04