Efficacy and Safety of Extracorporeal Biofeedback

Female Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910338
• Other study ID #: 2007-06-075
• Status: Completed
• Phase: N/A
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: April 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Irwon-dong
Korea, Republic of	Asan Medical Center, Ulsan College of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
KYU-SUNG LEE	Furun Medical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW).		After 12 weeks of treatment