Clinical trial NCT00571350: Anterior Vaginal Wall Reconstruction
Official title: Anterior Vaginal Wall Reconstruction: Anterior Colporrhaphy Reinforced With Tension Free Vaginal Tape Underneath Bladder Base
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Vaginal Prolapse
Keywords: Cystocele
tension free vaginal tapes
urinary incontinence
Lead sponsor: Hippocration General Hospital
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: 2008
Secondary outcomes:
measure: GOOD QUALITY OF LIFE FOR PATIENTS
timeFrame: 2008
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Medical School Aristotle University
Study officials:
affiliation: HIPPOKRATIO UNIVERSITY HOSPITAL
name: ANGELOS DANIILIDIS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HIPPOKRATIO UNIVERSITY HOSPITAL
name: JOHN TZAFETTAS, PROFESSOR
role: STUDY_DIRECTOR
affiliation: HIPPOKRATIO UNIVERSITY HOSPITAL
name: THEOHARIS TANTANASIS, ASS PROF
role: PRINCIPAL_INVESTIGATOR
References:
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.