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Anterior Vaginal Wall Reconstruction

Primary Purpose

Vaginal Prolapse

Status
Unknown status
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
tvt-o operation
tvt o operation
Sponsored by
Hippocration General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaginal Prolapse focused on measuring Cystocele, tension free vaginal tapes, urinary incontinence

Eligibility Criteria

50 Years - 77 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Medical School Aristotle University

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

women with vaginal prolapse who underwent TVT O

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

GOOD QUALITY OF LIFE FOR PATIENTS

Full Information

First Posted
December 10, 2007
Last Updated
December 10, 2007
Sponsor
Hippocration General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00571350
Brief Title
Anterior Vaginal Wall Reconstruction
Official Title
Anterior Vaginal Wall Reconstruction: Anterior Colporrhaphy Reinforced With Tension Free Vaginal Tape Underneath Bladder Base
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hippocration General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Objective: 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. Methods: Fifty Caucasian women 50 to 77 years old (mean age 66.6 years), 2 pre and 48 post menopausal with stage II-IV pelvic organ prolapse, enrolled into the study. Vaginal reconstructive surgery included an anterior colporrhaphy in all patients, posterior colpoperineorrhaphy in 28 patients and hysterectomy in 36 patients. They were randomly divided in a control group of 22 women and a study group of 28 women. As reinforcement to the anterior colporrhaphy procedure a polypropylene tape (TVT-O) was placed not under the midurethra, as originally described in case of stress incontinence, but underneath the bladder base and was fixed there with polyglactin sutures, in the study group. The postoperative follow up was carried out in frequent intervals of 4 months (total 48 months). The assessment of the anatomic result included evaluation of the operated sites and of the position of the tapes inserted on clinical grounds and after perineal sonography, which measured the distance of the bladder base to the inferior edge of the symphysis pubis. Results: In all patients the postoperative correction of the anterior vaginal wall was sufficient; the mean distance of the bladder base to the inferior edge of the symphysis pubis was 1.5 cm (range 1.0-2.2 cm). Mean residual urine volume was 30 ml. There were postoperatively 2 cases of stress incontinence and two cases of urge incontinence one in each group. There was no case of tape erosion noted, no dyspareunia and no recurrent cystocele in the study group. Four cases of recurrent cystocele (20%) were reported in our control group. Conclusion: The tension free vaginal tape, particularly TVT-O, placed underneath the bladder base, when performed concomitantly to the anterior colporrhaphy appears to be safe and effective. While the preliminary results of our study are encouraging, larger series of patients and longer follow up are required to verify the effectiveness of the aforementioned modification.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Prolapse
Keywords
Cystocele, tension free vaginal tapes, urinary incontinence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
women with vaginal prolapse who underwent TVT O
Intervention Type
Procedure
Intervention Name(s)
tvt-o operation
Other Intervention Name(s)
Johnson & Johnson Ethicon Gyneacare, Somerville, NJ, USA
Intervention Description
transvaginal tention free obturator tape
Intervention Type
Procedure
Intervention Name(s)
tvt o operation
Other Intervention Name(s)
tention free vaginal tape
Intervention Description
transobturator vaginal tape insertion
Primary Outcome Measure Information:
Title
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.
Time Frame
2008
Secondary Outcome Measure Information:
Title
GOOD QUALITY OF LIFE FOR PATIENTS
Time Frame
2008

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women 50-77 years old with stage II-IV organ prolapse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANGELOS DANIILIDIS, MD
Organizational Affiliation
HIPPOKRATIO UNIVERSITY HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JOHN TZAFETTAS, PROFESSOR
Organizational Affiliation
HIPPOKRATIO UNIVERSITY HOSPITAL
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
THEOHARIS TANTANASIS, ASS PROF
Organizational Affiliation
HIPPOKRATIO UNIVERSITY HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical School Aristotle University
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
11408853
Citation
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.
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Anterior Vaginal Wall Reconstruction

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