Efficacy Study of Vaginal Mesh for Anterior Prolapse
Completed · Phase 4
Conditions studied: Vaginal Prolapse, Uterine Prolapse, Cystocele, Pelvic Organ Prolapse
In brief
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.
Key facts
- Study ID
- NCT00557882
- Run by
- Medstar Health Research Institute
- People needed
- 65
- Starts
- 2007-06-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2020-10-30
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- women age > 21
- diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery
- available for 12 months of follow-up
- able to complete study questionnaires and assessments.
- available for 12 months follow-up
You may not qualify if…
- Uterus in place.
- No anterior vaginal prolapse.
- Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system.
- Current intermittent self catheterization.
- Pregnancy or desire for future fertility.
- Presence of an adnexal or ovarian mass.
- Shortened vagina.
- Other laparoscopic or abdominal/pelvic surgery in the past 3 months.*
- Known neurologic or medical condition affecting bladder function, e.g. multiple sclerosis, spinal cord injury.
- Need for surgery requiring an abdominal incision.
- <12 months post-partum. (Enrollment can be deferred until time requirement has been met).
Where it is running
- Wahington Hospital Center — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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