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Efficacy Study of Vaginal Mesh for Anterior Prolapse
Recruiting
I'm InterestedTrial ID: NCT00557882
Purpose
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.
Official Title
A Randomized Clinical Trial of Vaginal Mesh for Anterior Prolapse
Stanford Investigator(s)
Eric R. Sokol, MD
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology
Eligibility
Inclusion Criteria:
1. women age > 21
2. diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery
3. available for 12 months of follow-up
4. able to complete study questionnaires and assessments.
5. available for 12 months follow-up
Exclusion Criteria:
1. Uterus in place.
2. No anterior vaginal prolapse.
3. 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.
4. Current intermittent self catheterization.
5. Pregnancy or desire for future fertility.
6. Presence of an adnexal or ovarian mass.
7. Shortened vagina.
8. Other laparoscopic or abdominal/pelvic surgery in the past 3 months.*
9. Known neurologic or medical condition affecting bladder function, e.g. multiple
sclerosis, spinal cord injury.
10. Need for surgery requiring an abdominal incision.
11. <12 months post-partum. (Enrollment can be deferred until time requirement has been
met).
Intervention(s):
device: synthetic polypropylene mesh
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Tine Bjornlund
6507247826