NCT01497171

Brief Summary

This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2011

Geographic Reach
2 countries

6 active sites

Status
terminated

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

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 21, 2014

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

1.5 years

First QC Date

December 20, 2011

Results QC Date

August 6, 2014

Last Update Submit

August 6, 2014

Conditions

Pelvic Organ Prolapse

Keywords

CystoceleBladder prolapseAnterior prolapseVaginal prolapseUterine prolapseUrinary incontinence

Outcome Measures

Primary Outcomes (1)

  • Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.

    Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.

    12 months

Study Arms (2)

Elevate Mesh

ACTIVE COMPARATOR

Elevate transvaginal mesh - surgical repair of prolapse

Procedure: Elevate Mesh

Anterior Colporrhaphy

ACTIVE COMPARATOR

Anterior colporrhaphy - surgical repair of prolapse

Procedure: Anterior Colporrhaphy

Interventions

Elevate MeshPROCEDURE

Transvaginal mesh repair of anterior vaginal prolapse

Elevate Mesh
Anterior ColporrhaphyPROCEDURE

Traditional suture repair of anterior vaginal prolapse

Anterior Colporrhaphy

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with symptomatic pelvic organ prolapse who opt for a vaginal repair
  • Require both apical and anterior compartment repairs
  • Willing to return for follow-up visit
  • Understand and have signed informed consent to undergo randomization
  • Need both an apical and anterior repair
  • All trial participants who have a uterus will require a hysterectomy

You may not qualify if:

  • Known or suspected vulvodynia
  • Known or suspected interstitial cystitis
  • History of chronic pelvic pain
  • Current pregnancy
  • Desire to maintain fertility
  • History of reconstructive pelvic surgery with synthetic mesh
  • History of radical pelvic surgery
  • History of pelvic radiation therapy
  • Currently undergoing treatment for a malignancy
  • Medically poor candidates for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kaiser-Permanente - North Valley

Roseville, California, 95661, United States

Location

Kaiser-Permanente - Santa Clara

Santa Clara, California, 95051, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Washington Hospital Center - MedStar Health

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

Location

The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

St. Hedwig's Krankenhaus

Berlin, 10115, Germany

Location

MeSH Terms

Conditions

Pelvic Organ ProlapseCystoceleUterine ProlapseUrinary Incontinence

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesUrination DisordersLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Limitations and Caveats

Early termination of study due to changes in funding.

Results Point of Contact

Title
Dr. Emanuel C. Trabuco
Organization
Mayo Clinic
trabuco.emanuel@mayo.edu
507-284-7519

Study Officials

  • Emanuel Trabuco, MD

    Mayo Clinic

    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, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Obstetrics-Gynegology, Consultant-OB/Gyn Surgery

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 22, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 21, 2014

Results First Posted

August 21, 2014

Record last verified: 2014-08

Locations

DE(1)US(5)