CompletedPhase 4

Efficacy Study of Vaginal Mesh for Anterior Prolapse

United States65 participantsStarted 2007-06

Plain-language summary

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.

Who can participate

Age range21 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.\*

What they're measuring

The Primary Outcome Measure for Objective Treatment Success is Anterior Prolapse, Point Ba at Stage 0 or 1 (Defined as Maximal Descent of the Anterior Wall to Greater Than 1 cm Above the Hymen) at One Year.

Timeframe: 1 year

Trial details

NCT IDNCT00557882

SponsorMedstar Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-10

Results submitted2020-09-04

View on ClinicalTrials.gov More Vaginal Prolapse trials