Phase 4
N=65
Efficacy Study of Vaginal Mesh for Anterior Prolapse
Vaginal Prolapse · Uterine Prolapse · Cystocele · Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT00557882 ↗Enrolled (actual)
65
Serious AEs
7.7%
Results posted
Oct 2020
Primary outcome: Primary: 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. — 12; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- synthetic polypropylene mesh (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Medstar Health Research Institute
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
12; 10 | — |
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.
Eligibility Criteria
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.*
- Known neurologic or medical condition affecting bladder function, e.g. multiple sclerosis, spinal cord injury.
- Need for surgery requiring an abdominal incision.
- <12 months post-partum. (Enrollment can be deferred until time requirement has been met).
Data sourced from ClinicalTrials.gov (NCT00557882). 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.