Efficacy and Safety of Extracorporeal Biofeedback

KYU-SUNG LEE100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Female Stress Urinary Incontinence

Interventions

PFMT with Extracorporeal BiofeedbackDEVICE

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

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Samsung Medical Center

Irwon-dong, South Korea

Asan Medical Center, Ulsan College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test.

Time frame: After 12 weeks of treatment

Secondary Outcomes

Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength.

Time frame: After 12 weeks of treatment

Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW).

Time frame: After 12 weeks of treatment

Data from ClinicalTrials.gov

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