NCT00271102

Brief Summary

The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

December 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2005

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

September 27, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

4.1 years

First QC Date

December 29, 2005

Results QC Date

August 17, 2011

Last Update Submit

September 26, 2019

Conditions

Prolapse

Keywords

Cystocele, prolapse, anterior repair, colporrhaphy

Outcome Measures

Primary Outcomes (1)

  • Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery

    POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.

    4 years

Secondary Outcomes (1)

  • The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse.

    4 years

Study Arms (2)

Anterior colporrhaphy

ACTIVE COMPARATOR

Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)

Procedure: anterior vaginal repair (colporrhaphy)Procedure: abdominal paravaginal defect repair

Paravaginal defect repair

ACTIVE COMPARATOR

Abdominal paravaginal defect repair cystocele (dropped bladder)

Procedure: anterior vaginal repair (colporrhaphy)Procedure: abdominal paravaginal defect repair

Interventions

anterior vaginal repair (colporrhaphy)PROCEDURE

vaginal repair

Anterior colporrhaphyParavaginal defect repair
abdominal paravaginal defect repairPROCEDURE

abdominal repair

Anterior colporrhaphyParavaginal defect repair

Eligibility Criteria

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

You may qualify if:

  • Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.

You may not qualify if:

  • Patients with at least 2 previous prolapse surgeries
  • Patients who are pregnant or planning to have a pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Related Publications (1)

  • Minassian VA, Parekh M, Poplawsky D, Gorman J, Litzy L. Randomized controlled trial comparing two procedures for anterior vaginal wall prolapse. Neurourol Urodyn. 2014 Jan;33(1):72-7. doi: 10.1002/nau.22396. Epub 2013 Mar 18.

    PMID: 23508540DERIVED

Related Links

MeSH Terms

Conditions

ProlapseCystocele

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ Prolapse

Results Point of Contact

Title
Office of Research Compliance
Organization
Geisinger
orc@geisinger.edu
570-214-9628

Study Officials

  • Vatche A Minassian, MD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2005

First Posted

December 30, 2005

Study Start

January 1, 2006

Primary Completion

February 1, 2010

Study Completion

August 1, 2011

Last Updated

September 27, 2019

Results First Posted

September 27, 2019

Record last verified: 2019-09

Locations

US(1)