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Anterior Vaginal Wall Reconstruction

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hippocration General Hospital
ClinicalTrials.gov Identifier:
NCT00571350
First received: December 10, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

December 10, 2007
December 10, 2007
January 2005
Not Provided
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
GOOD QUALITY OF LIFE FOR PATIENTS [ Time Frame: 2008 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Anterior Vaginal Wall Reconstruction
Anterior Vaginal Wall Reconstruction: Anterior Colporrhaphy Reinforced With Tension Free Vaginal Tape Underneath Bladder Base

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Vaginal Prolapse
  • Procedure: tvt-o operation
    transvaginal tention free obturator tape
    Other Name: Johnson & Johnson Ethicon Gyneacare, Somerville, NJ, USA
  • Procedure: tvt o operation
    transobturator vaginal tape insertion
    Other Name: tention free vaginal tape
Active Comparator: A
women with vaginal prolapse who underwent TVT O
Interventions:
  • Procedure: tvt-o operation
  • Procedure: tvt o operation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
December 2007
Not Provided

Inclusion Criteria:

  • Women 50-77 years old with stage II-IV organ prolapse
Female
50 Years to 77 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00571350
ARISFC, HIPPOKRATIO HOSPITAL
No
2nd OBSTETRICS AND GYNECOLOGY UNIVERSITY CLINIC, HIPPOKRATIO UNIVERSITY HOSPITAL
Hippocration General Hospital
Not Provided
Principal Investigator: ANGELOS DANIILIDIS, MD HIPPOKRATIO UNIVERSITY HOSPITAL
Study Director: JOHN TZAFETTAS, PROFESSOR HIPPOKRATIO UNIVERSITY HOSPITAL
Principal Investigator: THEOHARIS TANTANASIS, ASS PROF HIPPOKRATIO UNIVERSITY HOSPITAL
Hippocration General Hospital
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP