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Colpocleisis for Advanced Pelvic Organ Prolapse
NCT00271037 · View on ClinicalTrials.gov ↗
Study Summary
Pelvic organ prolapse occurs when the pelvic organs (e.g., the uterus or bladder) fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. Some types of surgery try to restore the normal anatomy and function of the vagina (i.e., reconstructive surgery). Other surgery repairs the prolapse by essentially closing the vagina (e.g., colpocleisis or colpectomy), thereby leaving a woman unable to have vaginal intercourse in the future. The use of colpocleisis has not been well-studied. The current literature is lacking sufficient studies of colpocleisis to fully understand its risks and benefits for women considering surgery for prolapse. Traditionally, colpocleisis has been restricted to elderly women thought to be poor medical risks for prolonged reconstructive surgery. This study will describe the postoperative course of women who undergo colpocleisis, with particular attention to the persistence or recurrence of urinary incontinence and patient satisfaction after the colpocleisis prolapse surgery.
Conditions Studied
Interventions
- PROCEDURE Colpocleisis prolapse repair surgery
- PROCEDURE sling or other to treat or prevent stress incontinence
Study Locations (6)
Alabama
- University of Alabama — Birmingham
Illinois
- Loyola University — Maywood
Iowa
- University of Iowa — Iowa City
Maryland
- Johns Hopkins University — Baltimore
North Carolina
- University of North Carolina — Chapel Hill
Pennsylvania
- University of Pittsburgh — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2004-07 |
| Est. Completion | 2007-04 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)237 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00271037
The ClinicalTrials.gov registry entry for NCT00271037 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 237 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 2 interventions — of which Colpocleisis prolapse repair surgery 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: NCT00271037 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Alabama, Illinois, Iowa. 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 NCT00271037 about?
NCT00271037 is a clinical study titled "Colpocleisis for Advanced Pelvic Organ Prolapse". Pelvic organ prolapse occurs when the pelvic organs (e.g., the uterus or bladder) fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. Some types of surgery try to restore the normal anatomy and function of the vagina (i.e., reconstructive surgery). Other surgery ...
What is the current status of trial NCT00271037?
This trial is currently completed. The enrollment target is 152 participants. The study started on 2004-07. Estimated completion is 2007-04.
What conditions does trial NCT00271037 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse, Stress Urinary Incontinence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00271037?
The interventions under investigation include: Colpocleisis prolapse repair surgery (PROCEDURE), sling or other to treat or prevent stress incontinence (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00271037?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 237 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00271037 being conducted?
This trial has 6 study locations across Alabama, Illinois, Iowa, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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