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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: Completed NA study of Pelvic Organ Prolapse, sponsored by NICHD Pelvic Floor Disorders Network.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively acr
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 |
What the finished NCT01166373 record still lists
NCT01166373 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, above the 138-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (107% higher).
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 lists 7 locations in 7 states (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.
Learn More About Clinical Trials
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Where NCT01166373's enrollment target sits among peer trials
285 5th of 40 higher than 36 of 40 other Pelvic Organ Prolapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Organ Prolapse 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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