N/A Completed N=65 Randomized Double-blind Treatment

Efficacy Study of Vaginal Mesh for Prolapse

pelvic organ prolapse · uterine prolapse · vaginal prolapse · Cystocele

Source: ClinicalTrials.gov NCT00475540 ↗

Enrolled (actual)

Serious AEs

7.7%

Results posted

Oct 2022

Primary outcomePrimary: Number of Participants With Anatomic Cure at 3 Years — 20; 21; 8; 8 Participants — p=<0.05

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 pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Anatomic Cure at 3 Years	20; 21; 8; 8; 15; 12	<0.05 sig
SECONDARY Bothersome Dyspareunia	5; 5; 2; 1; 2; 1	—

Eligibility Criteria

Inclusion Criteria

Woman > 21 yrs
Stage II-IV vaginal prolapse
Desires vaginal reconstructive surgery
Able to complete study questionnaires and assessments
Uterus < 12 weeks size
Available for 12 months follow-up

Exclusion Criteria

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 catheterization.
Pregnancy or desire for future fertility.
Presence of an adnexal mass.
Shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys).
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 concomitant surgery requiring an abdominal incision.
< 12 months post-partum.
Non-english speaking

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00475540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.