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NCT00597935 · ClinicalTrials.gov registry record · NA
Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial
A NA study, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- NA
- Development phase
- 374
- Enrollment target
NCT00597935 is a NA study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 374 participants.
The verdict
NCT00597935, a NA study, has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- NA
- Development phase
- 374 participants
- Enrollment target
Study Summary
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are: 1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and 2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.
Interventions
- PROCEDURE SSLF
- PROCEDURE ULS
- BEHAVIORAL PMT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00597935
The ClinicalTrials.gov registry entry for NCT00597935 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 374 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which SSLF is the first listed.
NCT00597935 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00597935 about?
NCT00597935 is a clinical study titled "Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial". Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most like...
What is the current status of trial NCT00597935?
This trial is currently completed. It is a NA study. The enrollment target is 374 participants. The study started on 2008-02. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00597935?
The interventions under investigation include: SSLF (PROCEDURE), ULS (PROCEDURE), PMT (BEHAVIORAL).
Who is sponsoring clinical trial NCT00597935?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
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