Clinical trial NCT00475540: Efficacy Study of Vaginal Mesh for Prolapse
Official title: A Randomized Clinical Trial of Vaginal Mesh for Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Uterine Prolapse
Vaginal Prolapse
Cystocele
Rectocele
Keywords: prolapse
uterus
pelvic organ
vaginal prolpase
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2007-05-21
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 pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.

Detailed description: Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction. Unfortunately, safety and efficacy data have lagged behind the technical advancements. No randomized controlled trials of different vaginal apical suspension procedures have been reported. The use of synthetic vaginal mesh has evolved due to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. This trial will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery for vaginal Stage II-IV prolapse.

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

Primary outcomes:
measure: Number of Participants With Anatomic Cure at 3 Years
timeFrame: 3 year
Secondary outcomes:
measure: Bothersome Dyspareunia
timeFrame: 3 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Cheryl Iglesia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gutman RE, Nosti PA, Sokol AI, Sokol ER, Peterson JL, Wang H, Iglesia CB. Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):770-777. doi: 10.1097/AOG.0b013e3182a49dac.
citation: Iglesia CB, Sokol AI, Sokol ER, Kudish BI, Gutman RE, Peterson JL, Shott S. Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol. 2010 Aug;116(2 Pt 1):293-303. doi: 10.1097/AOG.0b013e3181e7d7f8.