NCT00571350

Brief Summary

The purpose of this study is to assess the effectiveness of the polypropylene tape in preventing cystocele recurrence when placed underneath the bladder base as a concomitant measure to the anterior colporrhaphy procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
Last Updated

December 12, 2007

Status Verified

December 1, 2007

First QC Date

December 10, 2007

Last Update Submit

December 10, 2007

Conditions

Vaginal Prolapse

Keywords

Cystoceletension free vaginal tapesurinary incontinence

Outcome Measures

Primary Outcomes (1)

  • The purpose of this study is to assess the effectiveness of the polypropylene tape in preventing cystocele recurrence when placed underneath the bladder base as a concomitant measure to the anterior colporrhaphy procedure.

    2008

Secondary Outcomes (1)

  • GOOD QUALITY OF LIFE FOR PATIENTS

    2008

Study Arms (1)

A

ACTIVE COMPARATOR

women with vaginal prolapse who underwent TVT O

Procedure: tvt-o operationProcedure: tvt o operation

Interventions

tvt-o operationPROCEDURE

transvaginal tention free obturator tape

Also known as: Johnson & Johnson Ethicon Gyneacare, Somerville, NJ, USA
A
tvt o operationPROCEDURE

transobturator vaginal tape insertion

Also known as: tention free vaginal tape
A

Eligibility Criteria

Age50 Years - 77 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women 50-77 years old with stage II-IV organ prolapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School Aristotle University

Thessaloniki, Greece

Location

Related Publications (1)

  • Sand PK, Koduri S, Lobel RW, Winkler HA, Tomezsko J, Culligan PJ, Goldberg R. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. Am J Obstet Gynecol. 2001 Jun;184(7):1357-62; discussion 1362-4. doi: 10.1067/mob.2001.115118.

    PMID: 11408853BACKGROUND

MeSH Terms

Conditions

Uterine ProlapseCystoceleUrinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

  • ANGELOS DANIILIDIS, MD

    HIPPOKRATIO UNIVERSITY HOSPITAL

    PRINCIPAL INVESTIGATOR

  • JOHN TZAFETTAS, PROFESSOR

    HIPPOKRATIO UNIVERSITY HOSPITAL

    STUDY DIRECTOR

  • THEOHARIS TANTANASIS, ASS PROF

    HIPPOKRATIO UNIVERSITY HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 12, 2007

Study Start

January 1, 2005

Study Completion

December 1, 2007

Last Updated

December 12, 2007

Record last verified: 2007-12

Locations

GR(1)