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NCT01166373 · ClinicalTrials.gov registry record · NA
The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study
A NA study of Pelvic Organ Prolapse, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- NA
- Development phase
- 285
- Enrollment target
- 7
- Study locations
NCT01166373 is a NA study of Pelvic Organ Prolapse that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 285 participants, above the 138-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (107% higher). The trial reports 7 study locations across 7 states.
The verdict
NCT01166373, a NA study of Pelvic Organ Prolapse, has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- NA
- Development phase
- 285 participants
- Enrollment target
- 7
- Study locations
Study Summary
Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed. We propose to test the following null hypotheses: 1. There will be no difference in time to surgical failure between uterosacral vaginal vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years after surgery. 2. The addition of a standardized video detailing the importance of long-term follow-up studies for POP to the informed consent process will not improve enrollment or retention in E-OPTIMAL.
Conditions Studied
Interventions
- OTHER Usual Care
- BEHAVIORAL Enrollment video
- PROCEDURE SSLF
- PROCEDURE ULS
- BEHAVIORAL PMT
Study Locations (7)
Alabama
- University of Alabama - Birmingham
California
- University of California, San Diego Medical Center - La Jolla
Illinois
- Loyola University Medical Center - Maywood
North Carolina
- Duke University - Durham
Ohio
- Cleveland Clinic - Cleveland
Texas
- University of Texas Southwestern - Dallas
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2010-04 |
| Est. Completion | 2016-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01166373
The ClinicalTrials.gov registry entry for NCT01166373 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 285 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 138-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (107% higher). The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 5 interventions - of which Usual Care is the first listed.
NCT01166373 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Alabama, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01166373 about?
NCT01166373 is a clinical study titled "The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study". Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with...
What is the current status of trial NCT01166373?
This trial is currently completed. It is a NA study. The enrollment target is 285 participants. The study started on 2010-04. Estimated completion is 2016-07.
What conditions does trial NCT01166373 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse.
What interventions are being tested in trial NCT01166373?
The interventions under investigation include: Usual Care (OTHER), Enrollment video (BEHAVIORAL), SSLF (PROCEDURE), ULS (PROCEDURE), PMT (BEHAVIORAL).
Who is sponsoring clinical trial NCT01166373?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01166373 being conducted?
This trial has 7 study locations across Alabama, California, Illinois, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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