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
  Purpose

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.


Condition Intervention Phase
Vaginal Prolapse
Procedure: tvt-o operation
Procedure: tvt o operation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Anterior Vaginal Wall Reconstruction: Anterior Colporrhaphy Reinforced With Tension Free Vaginal Tape Underneath Bladder Base

Resource links provided by NLM:


Further study details as provided by Hippocration General Hospital:

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. [ Time Frame: 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GOOD QUALITY OF LIFE FOR PATIENTS [ Time Frame: 2008 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2005
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
Active Comparator: A
women with vaginal prolapse who underwent TVT O
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 77 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 50-77 years old with stage II-IV organ prolapse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571350

Locations
Greece
Medical School Aristotle University
Thessaloniki, Greece
Sponsors and Collaborators
Hippocration General Hospital
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: 2nd OBSTETRICS AND GYNECOLOGY UNIVERSITY CLINIC, HIPPOKRATIO UNIVERSITY HOSPITAL
ClinicalTrials.gov Identifier: NCT00571350     History of Changes
Other Study ID Numbers: ARISFC, HIPPOKRATIO HOSPITAL
Study First Received: December 10, 2007
Last Updated: December 10, 2007
Health Authority: Greece: Ethics Committee

Keywords provided by Hippocration General Hospital:
Cystocele
tension free vaginal tapes
urinary incontinence

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on July 24, 2014