Efficacy and Safety of Extracorporeal Biofeedback
Not Applicable
Completed
- Conditions
- Female Stress Urinary Incontinence
- Interventions
- Device: PFMT with Extracorporeal Biofeedback
- Registration Number
- NCT00910338
- Lead Sponsor
- KYU-SUNG LEE
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PFMT with Extracorporeal Biobeedback PFMT with Extracorporeal Biofeedback -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (2)
Samsung Medical Center
🇰🇷Irwon-dong, Korea, Republic of
Asan Medical Center, Ulsan College of Medicine
🇰🇷Seoul, Korea, Republic of