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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Prolapse
• Intervention / Treatment: Procedure: tvt-o operation; Procedure: tvt o operation

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece
    • Medical School Aristotle University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; women with vaginal prolapse who underwent TVT O	Procedure: tvt-o operation; transvaginal tention free obturator tape; Other Names: Johnson & Johnson Ethicon Gyneacare, Somerville, NJ, USA; Procedure: tvt o operation; transobturator vaginal tape insertion; Other Names: tention free vaginal tape

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
GOOD QUALITY OF LIFE FOR PATIENTS	2008

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• UROGYNECOLOGY

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Study Completion (Anticipated): December 1, 2007

Study Registration Dates

• First Submitted: December 10, 2007
• First Submitted That Met QC Criteria: December 10, 2007
• First Posted (Estimate): December 12, 2007

Study Record Updates

• Last Update Posted (Estimate): December 12, 2007
• Last Update Submitted That Met QC Criteria: December 10, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Cystocele; urinary incontinence; tension free vaginal tapes
• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Uterine Prolapse
• Other Study ID Numbers: ARISFC; HIPPOKRATIO HOSPITAL