Clinical trial NCT00557882: Efficacy Study of Vaginal Mesh for Anterior Prolapse
Official title: A Randomized Clinical Trial of Vaginal Mesh for Anterior Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Prolapse
Uterine Prolapse
Cystocele
Pelvic Organ Prolapse
Keywords: prolapse
uterus
mesh
bladder
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2007-11-14
Enrollment: 65
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Multiple vaginal, abdominal and laparoscopic procedures have been described for surgical correction of pelvic support problems. However, conventional pelvic reconstructive surgeries have been associated with a 20-30% prolapse recurrence rate. The anterior vaginal wall is the site most often recognized as the area of vaginal prolapse recurrence. Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction in an attempt to improve surgical cure rates. Unfortunately, safety and efficacy data have lagged behind the technical advancements.

This trial will randomize women with advanced anterior wall prolapse to two treatment arms: vaginal reconstructive surgery with mesh and vaginal reconstructive surgery without mesh. The primary outcome is cure of anterior wall prolapse at one year. Secondary outcomes are cure of apical and posterior wall prolapse, quality-of-life measures and complication rates. Patients will be approached for recruitment only after they have made the decision to undergo vaginal surgery for anterior prolapse. The patient and examiner will be blinded to the surgical treatment assignment. Interim measurement of primary and secondary outcomes will be conducted three months post-operatively. Additional follow-up will be conducted at one-year intervals subsequent to the expected one-year endpoint.

Eligibility criteria: 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).

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Wahington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Andrew I Sokol, MD
role: PRINCIPAL_INVESTIGATOR
References: