Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2005-01-31
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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A
women with vaginal prolapse who underwent TVT O
tvt-o operation
transvaginal tention free obturator tape
tvt o operation
transobturator vaginal tape insertion
Interventions
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tvt-o operation
transvaginal tention free obturator tape
tvt o operation
transobturator vaginal tape insertion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
50 Years
77 Years
FEMALE
No
Sponsors
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Hippocration General Hospital
OTHER
Responsible Party
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HIPPOKRATIO UNIVERSITY HOSPITAL
Principal Investigators
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ANGELOS DANIILIDIS, MD
Role: PRINCIPAL_INVESTIGATOR
HIPPOKRATIO UNIVERSITY HOSPITAL
JOHN TZAFETTAS, PROFESSOR
Role: STUDY_DIRECTOR
HIPPOKRATIO UNIVERSITY HOSPITAL
THEOHARIS TANTANASIS, ASS PROF
Role: PRINCIPAL_INVESTIGATOR
HIPPOKRATIO UNIVERSITY HOSPITAL
Locations
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Medical School Aristotle University
Thessaloniki, , Greece
Countries
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References
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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.
Related Links
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UROGYNECOLOGY
Other Identifiers
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HIPPOKRATIO HOSPITAL
Identifier Type: -
Identifier Source: secondary_id
ARISFC
Identifier Type: -
Identifier Source: org_study_id