Anterior Vaginal Wall Reconstruction

Vaginal Prolapse Clinical Trial

Official title:

Anterior Vaginal Wall Reconstruction: Anterior Colporrhaphy Reinforced With Tension Free Vaginal Tape Underneath Bladder Base

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00571350
• Other study ID #: ARISFC
• Secondary ID: HIPPOKRATIO HOSP
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: December 10, 2007
• Last updated: December 10, 2007
• Start date: January 2005
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: Hippocration General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 77 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaginal Prolapse

Intervention

Procedure:
• tvt-o operation
transvaginal tention free obturator tape
• tvt o operation
transobturator vaginal tape insertion

Locations

Country	Name	City	State
Greece	Medical School Aristotle University	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hippocration General Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	GOOD QUALITY OF LIFE FOR PATIENTS		2008	No

External Links

•   UROGYNECOLOGY