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.

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