Anterior Vaginal Wall Reconstruction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00571350|
Recruitment Status : Unknown
Verified December 2007 by Hippocration General Hospital.
Recruitment status was: Enrolling by invitation
First Posted : December 12, 2007
Last Update Posted : December 12, 2007
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Prolapse||Procedure: tvt-o operation Procedure: tvt o operation||Phase 1 Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anterior Vaginal Wall Reconstruction: Anterior Colporrhaphy Reinforced With Tension Free Vaginal Tape Underneath Bladder Base|
|Study Start Date :||January 2005|
|Estimated Study Completion Date :||December 2007|
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
- 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 ]
- GOOD QUALITY OF LIFE FOR PATIENTS [ Time Frame: 2008 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571350
|Medical School Aristotle University|
|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|