Document Detail


Efficacy of a modified technique for TVT-O positioning: a twelve-month, randomized, single-blind, multicenter, non-inferiority study.
MedLine Citation:
PMID:  23266205     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate the impact of a more limited paraurethral dissection, avoidance of perforating the obturator membrane with scissors or guide, and a more medial trajectory of the trocar in positioning the TVT-O device on stress urinary incontinence cure rates. STUDY DESIGN: One hundred and ten patients were recruited for this randomized, single blind, multicenter, non-inferiority study, with a 1:1 ratio to undergo the traditional (n=55) or the modified (n=55) technique. Preoperatively, patients underwent POP-Q staging, Q-tip test, challenge stress test and urodynamics, and completed the I-QoL, PISQ-12, and PGI-S questionnaires. During the post-operative period, patients attributed a pain VAS score 1, 3, 6, 12 and 24h after the procedure and were followed up at 12 months, undergoing the same baseline evaluations. The primary outcome was the cure rate (absence of urine leaks at the challenge stress test or urodynamic testing) one year after the procedure. The primary outcome was evaluated using a non-inferiority test. RESULTS: No differences were observed in cure rates (traditional technique 92.3% vs. modified technique 88.8% and non-inferiority P<0.05) and in questionnaire scores between the two groups. Post-operative pain was significantly lower in the modified technique group at each time point assessed, with the exception of 12h post-operatively. No differences between the two groups were observed in the number of analgesic vials administered. CONCLUSIONS: The modified technique does not seem to reduce the efficacy of TVT-O, but induces a reduction of post-operative pain.
Authors:
Giovanni A Tommaselli; Alessandro D'Afiero; Costantino Di Carlo; Carmen Formisano; Annamaria Fabozzi; Carmine Nappi
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-21
Journal Detail:
Title:  European journal of obstetrics, gynecology, and reproductive biology     Volume:  -     ISSN:  1872-7654     ISO Abbreviation:  Eur. J. Obstet. Gynecol. Reprod. Biol.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0375672     Medline TA:  Eur J Obstet Gynecol Reprod Biol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
Affiliation:
Department of Obstetrics and Gynecology, University of Naples "Federico II", Naples, Italy. Electronic address: gtommaselli@yahoo.it.
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