NCT00535301

Brief Summary

The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

July 28, 2011

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

3.2 years

First QC Date

September 24, 2007

Results QC Date

May 4, 2011

Last Update Submit

April 2, 2015

Conditions

CystoceleUterine ProlapseUrinary Incontinence

Keywords

cystoceleuterine prolapseurinary incontinence

Outcome Measures

Primary Outcomes (1)

  • Recurrent Stage II or Greater Anterior Vaginal Prolapse

    Pelvic Organ Prolapse Quantification Point Ba is the most distal position of any part of the anterior vagina between point Aa and the vaginal cuff or anterior vaginal fornix. Better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). Recurrent stage II or greater anterior vaginal prolapse is defined as POPQ Point Ba measurement equal to or greater (more positive) than -1.

    three years

Secondary Outcomes (2)

  • Operative Time

    perioperative

  • Vaginal Mesh Exposure

    perioperative

Study Arms (2)

Anterior Colporrhaphy (sutured repair)

PLACEBO COMPARATOR

Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures.

Procedure: sutured anterior vaginal prolapse repair

Perigee (grafted repair)

ACTIVE COMPARATOR

Anterior vaginal prolapse repair with graft

Device: grafted anterior prolapse repair

Interventions

grafted anterior prolapse repairDEVICE

anterior vaginal prolapse repair with graft

Also known as: Perigee Transobturator Prolapse Repair System
Perigee (grafted repair)
sutured anterior vaginal prolapse repairPROCEDURE

anterior vaginal prolapse repair with suture

Also known as: cystocele repair
Anterior Colporrhaphy (sutured repair)

Eligibility Criteria

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

You may qualify if:

  • stage II or greater anterior vaginal prolapse requiring surgical correction
  • age 21 years and older

You may not qualify if:

  • less than Stage II anterior vaginal prolapse
  • decline participation
  • pregnant or contemplating future pregnancy
  • prior anterior vaginal prolapse repair with biologic or synthetic graft
  • active or latent systemic infection
  • compromised immune system
  • previous pelvic irradiation or cancer
  • known hypersensitivity to polypropylene
  • uncontrolled diabetes mellitus
  • unable or unwilling to give valid informed consent
  • unable or unwilling to comply with the protocol
  • scheduled to undergo concomitant Burch colposuspension or pubovaginal sling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

Downey, California, 90242, United States

Location

Related Publications (2)

  • Gauruder-Burmester A, Koutouzidou P, Rohne J, Gronewold M, Tunn R. Follow-up after polypropylene mesh repair of anterior and posterior compartments in patients with recurrent prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Sep;18(9):1059-64. doi: 10.1007/s00192-006-0291-7. Epub 2007 Jan 12.

    PMID: 17219252BACKGROUND

  • Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol. 2008 Apr;111(4):891-8. doi: 10.1097/AOG.0b013e31816a2489.

    PMID: 18378748DERIVED

MeSH Terms

Conditions

CystoceleUterine ProlapseUrinary Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUterine DiseasesGenital Diseases, FemaleGenital DiseasesUrination DisordersLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Limitations and Caveats

-Small number of subjects, Single surgeon, Medium follow-up, Limited ability to detect uncommon adverse events and small differences in quality of life and sexual symptom scores, Concurrent pelvic reconstructive and anti-incontinence procedures

Results Point of Contact

Title
John N. Nguyen, MD
Organization
SCPMG/Kaiser Permanente
john.n.nguyen@kp.org
562-657-2642

Study Officials

  • John N Nguyen, MD

    Southern California Permanente Medical Group

    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

September 24, 2007

First Posted

September 26, 2007

Study Start

January 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 22, 2015

Results First Posted

July 28, 2011

Record last verified: 2015-04

Locations

US(1)