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NCT01672697 · ClinicalTrials.gov registry record · NA
Physical Therapy for Women With Obstetric Trauma and Anal Incontinence
A NA study, sponsored by TriHealth.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
NCT01672697: Completed NA study, sponsored by TriHealth.
NCT01672697 is a NA study that has completed, run by TriHealth. The registered enrollment target is 54 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
NCT01672697, a NA study, has completed, sponsored by TriHealth.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
Study Summary
Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically in regard to anal incontinence. To be able to study this, the investigators need to know how well the muscles of a woman's pelvic floor function after a vaginal delivery and this requires measuring their strength during a pelvic exam. At present, there are no studies that have looked at whether the intervention of PT/BT improves a woman's anal incontinence quality of life after sustaining genital trauma during vaginal deliveries
Primary Outcome
The Fecal Incontinence Quality of Life Scale (FIQOL) is a 29-item instrument developed with the support of the American Society of Colon and Rectal Surgeons that measures the impact of anal incontinence over four domains: Lifestyle, Coping/behavior, Depression/self-perceptions, and Embarrassment. The FIQL has demonstrated validity and reliability.
Interventions
- BEHAVIORAL Physical Therapy (PT) and Behavioral Therapy (BT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2012-09-12 |
| Est. Completion | 2016-03-17 |
| Phase | NA |
What the finished NCT01672697 record still lists
NCT01672697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 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 1 intervention - of which Physical Therapy (PT) and Behavioral Therapy (BT) is the first listed.
NCT01672697 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01672697 about?
NCT01672697 is a clinical study titled "Physical Therapy for Women With Obstetric Trauma and Anal Incontinence". Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically in regard to anal incontinence. To be able to study this, the investigat...
What is the current status of trial NCT01672697?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2012-09-12. Estimated completion is 2016-03-17.
What interventions are being tested in trial NCT01672697?
The interventions under investigation include: Physical Therapy (PT) and Behavioral Therapy (BT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01672697?
This trial is sponsored by TriHealth, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01672697's enrollment target sits among peer trials
54 1268th of 2000 higher than 730 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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