Trial Search Results

Efficacy Study of Vaginal Mesh for Anterior Prolapse

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Medstar Health Research Institute

Stanford Investigator(s):

Intervention(s):

  • Device: synthetic polypropylene mesh

Phase:

Phase 4

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).

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tine Bjornlund
6507247826
Recruiting