NCT00676000

Brief Summary

Vaginal prolapse is a common condition that is treated with surgical correction. Recently surgeons have been using mesh to augment the repair of vaginal prolapse. Common complications of this surgery include vaginal pain, pain during sex, infection or erosion of the mesh in the vagina. There are different ways to close the vaginal wall over the mesh used in these procedures. Currently, there is no accepted standard method of closing the vaginal wall. The purpose of this study is to find out the best way to close the surgical wound in the vagina. We will compare interrupted closure (separate stitches) to continuous closure (one long, running stitch). We hope to show in our study that one method of closure is better than the other.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable pain

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

1.7 years

First QC Date

May 8, 2008

Last Update Submit

March 17, 2009

Conditions

PainDyspareuniaSurgical Mesh

Outcome Measures

Primary Outcomes (1)

  • Mesh exposure

    One year

Secondary Outcomes (2)

  • Pain

    One year

  • Dyspareunia

    One year

Study Arms (2)

1

ACTIVE COMPARATOR

Interrupted vaginal closure

Procedure: Interrupted vaginal closure

2

ACTIVE COMPARATOR

Continuous vaginal closure

Procedure: Continuous vaginal closure

Interventions

Interrupted vaginal closurePROCEDURE

Horizontal mattress closure of vaginal mucosa over mesh

1
Continuous vaginal closurePROCEDURE

Running closure of vaginal mucosa over mesh

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for surgery to correct anterior vaginal prolapse with mesh kit

You may not qualify if:

  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainDyspareunia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Danielle Patterson, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 12, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2009

Last Updated

March 19, 2009

Record last verified: 2009-03