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NCT03194789 · ClinicalTrials.gov registry record · NA
The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence
A NA study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT03194789: Completed NA study, sponsored by Montefiore Medical Center.
NCT03194789 is a NA study that has completed, run by Montefiore Medical Center. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03194789, a NA study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study Summary
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that create dynamics similar to dynamic lumbosacral stabilization exercises. The investigators propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic stabilization exercises) which have shown benefit for incontinence. Instead of instructing patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE, the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur without the patient realizing. Beneficial pelvis and spine positioning can also be accomplished by strategic placement of the pods without having to instruct the patient on complicated maneuvers. Capitalizing on the excellent adherence and clinical benefits of FGBMM on related conditions, the investigators propose to evaluate the effects of FGBMM in addition to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban inner city population.
Primary Outcome
Improvement in symptoms of Stress Urinary Incontinence (SUI) measured by Urinary Distress Inventory) UDI - 6 questionnaire
Interventions
- DEVICE Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy
- OTHER Traditional Pelvic Floor Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-11-29 |
| Est. Completion | 2023-12-12 |
| Phase | NA |
What the finished NCT03194789 record still lists
NCT03194789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy is the first listed.
NCT03194789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03194789 about?
NCT03194789 is a clinical study titled "The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence". FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that create dynamics similar t...
What is the current status of trial NCT03194789?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2017-11-29. Estimated completion is 2023-12-12.
What interventions are being tested in trial NCT03194789?
The interventions under investigation include: Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy (DEVICE), Traditional Pelvic Floor Therapy (OTHER).
Who is sponsoring clinical trial NCT03194789?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03194789's enrollment target sits among peer trials
55 1264th of 2000 higher than 733 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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