Efficacy and Safety of Extracorporeal Biofeedback

KYU-SUNG LEE

Status: Completed

Conditions: Female Stress Urinary Incontinence

Treatments: Device: PFMT with Extracorporeal Biofeedback

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00910338

2007-06-075

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

PFMT with Extracorporeal Biobeedback

Experimental group

Treatment:

Device: PFMT with Extracorporeal Biofeedback