Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study
NCT01166373 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 285 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 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01166373 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Alabama, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01166373?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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