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NCT01337193 · ClinicalTrials.gov registry record · NA
Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence
A NA study, sponsored by Texas Woman's University.
- Terminated
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT01337193: Clinical Trial NA study, sponsored by Texas Woman's University.
NCT01337193 is a NA study that was terminated before completion, run by Texas Woman's University. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337193, a NA study, was terminated before completion, sponsored by Texas Woman's University.
- TERMINATED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence. The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback. All participants involved in the study will complete a general medical information questionnaire. In addition, all participants will have their PFM contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.
Primary Outcome
Pelvic floor muscle lift and length of pelvic floor muscle contraction will be measured using transabdominal ultrasound imaging. Ability to maintain continence during a cough will be measured by asking the participant to stand, contract the pelvic floor muscles, and cough. The participant will state whether or not they leaked urine.
Interventions
- OTHER Pelvic floor exercises with biofeedback
- OTHER Pelvic floor muscle exercises
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-05 |
| Phase | NA |
Why NCT01337193 stopped before completion
NCT01337193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Pelvic floor exercises with biofeedback is the first listed.
NCT01337193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01337193 about?
NCT01337193 is a clinical study titled "Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence". The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence. The ...
What is the current status of trial NCT01337193?
This trial is currently terminated. It is a NA study. The enrollment target is 28 participants. The study started on 2011-02. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01337193?
The interventions under investigation include: Pelvic floor exercises with biofeedback (OTHER), Pelvic floor muscle exercises (OTHER).
Who is sponsoring clinical trial NCT01337193?
This trial is sponsored by Texas Woman's University, which has 51 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01337193's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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