Efficacy Study of Vaginal Mesh for Anterior Prolapse

NCT00557882 | Completed Phase 4 Results DMC

• 1 other identifier: 2006-336
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Prolapse; Uterine Prolapse; Cystocele; Pelvic Organ Prolapse

Keywords

prolapse; uterus; mesh; bladder

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

mesh

ACTIVE COMPARATOR

Vaginal reconstructive surgery with synthetic polypropylene mesh

Device: synthetic polypropylene mesh

no mesh

ACTIVE COMPARATOR

Vaginal reconstructive surgery without mesh

Device: synthetic polypropylene mesh

Interventions

synthetic polypropylene mesh DEVICE

Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.

mesh; no mesh

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Wahington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Links

• Click clinical trials for more information about this study " A Randomized Clinical trial of Vaginal Mesh for Prolapse"

MeSH Terms

Conditions

Uterine Prolapse; Cystocele; Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Andrew Sokol, MD
• Organization: MedStar Washington Hospital Center

andrew.i.sokol@medstar.net

2028776526

Study Officials

• Andrew I Sokol, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2011
• Last Updated: October 30, 2020
• Results First Posted: October 30, 2020

Record last verified: 2020-10

Locations

US (1)