Efficacy Study of Vaginal Mesh for Anterior Prolapse
Trial ID or NCT#
NCT00557882
Status
RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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).
Investigator(s)
Eric R. Sokol, MD
Urogynecologist,
Pelvic surgeon,
Minimally invasive gynecologic surgeon,
Pelvic reconstructive surgeon,
Obstetrician and Gynecologist (OB-GYN)
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology
Contact us to find out if this trial is right for you.
Contact
Tine Bjornlund
6507247826
View on ClinicalTrials.gov
