Efficacy Study of Vaginal Mesh for Prolapse

NCT00475540 | Completed Results DMC

• 1 other identifier: 2006-232
• 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 pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.

Conditions

Pelvic Organ Prolapse; Uterine Prolapse; Vaginal Prolapse; Cystocele; Rectocele

Keywords

prolapse; uterus; pelvic organ; vaginal prolpase

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Anatomic Cure at 3 Years

  3 different measures for Anatomic cure using POPQ measurements: 1. POP-Q at Stage I or less\* (POP-Q points Ba, Bp or C -1 or less); 2. no prolapse beyond the hymen (Ba, Bp or C 0 or less); 3. no prolapse beyond the hymen (Ba, Bp 0 or less) with adequate apical support above the midvagina (C to TVL/2 or less) No bulge symptoms using Pelvic Floor Distress Inventory, PFDI question 3; do you see or feel a bulge in the vaginal area with response of no. Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better

  3 year

Secondary Outcomes (1)

• Bothersome Dyspareunia

  3 year

Study Arms (2)

Prolift mesh

ACTIVE COMPARATOR

vaginal prolapse repair with mesh

Device: synthetic monofilament polypropylene mesh

Prolapse repair without mesh

ACTIVE COMPARATOR

vaginal prolapse repair without mesh

Device: synthetic monofilament polypropylene mesh

Interventions

synthetic monofilament polypropylene mesh DEVICE

Vaginal prolapse repair with mesh

Also known as: Prolift

Prolapse repair without mesh; Prolift mesh

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Washington Hospital Center

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

Location

Related Publications (2)

• 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.

  PMID: 24084533 DERIVED

• 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.

  PMID: 20664388 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse; Cystocele; Rectocele; Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia

Results Point of Contact

• Title: Allie Moses, Manager, Clinical Research Systems and Recruitment Center
• Organization: MedStar Health Research Institute

Allison.E.Moses@MedStar.net

301-560-7353

Study Officials

• Cheryl Iglesia, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: May 17, 2007
• First Posted: May 21, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: October 12, 2022
• Results First Posted: October 12, 2022

Record last verified: 2022-07

Locations

US (1)