Efficacy and Safety of Extracorporeal Biofeedback

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00910338

Enrollment

100

Registered

2009-05-29

Start date

2007-07-31

Completion date

2009-12-31

Last updated

2019-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Stress Urinary Incontinence

Keywords

Pelvic Floor Muscle Training, Extracorporeal Biofeedback

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.

Interventions

DEVICEPFMT 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026