Efficacy Study of Vaginal Mesh for Anterior Prolapse

Pelvic Organ Prolapse Clinical Trial

— VAMP-A  

Official title:

A Randomized Clinical Trial of Vaginal Mesh for Anterior Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557882
• Other study ID #: 2006-336
• Status: Completed
• Phase: Phase 4
• Start date: June 2007
• Est. completion date: November 2011

Study information

• Verified date: October 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cystocele
• Pelvic Organ Prolapse
• Prolapse
• Uterine Prolapse
• Vaginal Prolapse

Intervention

Device:
• synthetic polypropylene mesh
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.

Locations

Country	Name	City	State
United States	Wahington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.		1 year

External Links

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