CompletedNot Applicable

Efficacy and Safety of Extracorporeal Biofeedback

South Korea100 participantsStarted 2007-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: After 12 weeks of treatment

Trial details

NCT IDNCT00910338

SponsorKYU-SUNG LEE

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-03

View on ClinicalTrials.gov More Female Stress Urinary Incontinence trials