Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial

Introduction and hypothesis We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI). Methods This was a noninferiority, prospective, randomized controll...

Full description

Saved in:
Bibliographic Details
Published in:International Urogynecology Journal 2013-09, Vol.24 (9), p.1459-1465
Main Authors: Bianchi-Ferraro, Ana Maria H. M., Jarmy-Di Bella, Zsuzsanna I. K., Castro, Rodrigo de A., Bortolini, Maria Augusta T., Sartori, Marair G. F., Girão, Manoel J. B. C.
Format: Article
Language:English
Subjects:
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by cdi_FETCH-LOGICAL-c372t-83b5ff6ec11b91731c5792e2827af6c754c777519c6d39d843381d429a5ecd803
cites cdi_FETCH-LOGICAL-c372t-83b5ff6ec11b91731c5792e2827af6c754c777519c6d39d843381d429a5ecd803
container_end_page 1465
container_issue 9
container_start_page 1459
container_title International Urogynecology Journal
container_volume 24
creator Bianchi-Ferraro, Ana Maria H. M.
Jarmy-Di Bella, Zsuzsanna I. K.
Castro, Rodrigo de A.
Bortolini, Maria Augusta T.
Sartori, Marair G. F.
Girão, Manoel J. B. C.
description Introduction and hypothesis We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI). Methods This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O ( n  = 56) or TVT-S ( n  = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King’s Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by >15 %. Statistical significance was fixed at 5 % ( p  
doi_str_mv 10.1007/s00192-012-1998-2
format article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1426515521</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3047442961</sourcerecordid><originalsourceid>FETCH-LOGICAL-c372t-83b5ff6ec11b91731c5792e2827af6c754c777519c6d39d843381d429a5ecd803</originalsourceid><addsrcrecordid>eNp1kUFvFSEUhYmxsc-2P6AbM4mbbtB7YRgGd6axatLERds14TFMSzMDT2BidNWfXibvaYyJKy6c754LHELOEd4hgHyfAVAxCsgoKtVT9oJssOWccmD8JdmA4pLytmPH5HXOjwDQgoBX5JhxBj0A35CnGx_uJ0d9sD77GJo81YPGxnlnkhuaH748NCWZkOO2LMmUmA7IWKuSnCnrJtcq52ZJPpj0s6luMVTBBes-NKap_UOc_a9quAopTlMtS_JmOiVHo5myOzusJ-Tu6tPt5Rd6_e3z18uP19RyyQrt-VaMY-cs4lah5GiFVMyxnkkzdlaK1kopBSrbDVwNff2FHoeWKSOcHXrgJ-Ri77tL8fvictGzz9ZNkwkuLlljyzqBQjCs6Nt_0Me4pFBvt1Ki5YLz1RD3lE0x5-RGvUt-rq_XCHqNR-_j0TUevcajWe15c3BetrMb_nT8zqMCbA_kKoV7l_4a_V_XZ7qKnD0</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1425435330</pqid></control><display><type>article</type><title>Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial</title><source>Springer Nature</source><creator>Bianchi-Ferraro, Ana Maria H. M. ; Jarmy-Di Bella, Zsuzsanna I. K. ; Castro, Rodrigo de A. ; Bortolini, Maria Augusta T. ; Sartori, Marair G. F. ; Girão, Manoel J. B. C.</creator><creatorcontrib>Bianchi-Ferraro, Ana Maria H. M. ; Jarmy-Di Bella, Zsuzsanna I. K. ; Castro, Rodrigo de A. ; Bortolini, Maria Augusta T. ; Sartori, Marair G. F. ; Girão, Manoel J. B. C.</creatorcontrib><description>Introduction and hypothesis We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI). Methods This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O ( n  = 56) or TVT-S ( n  = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King’s Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by &gt;15 %. Statistical significance was fixed at 5 % ( p  &lt; 0.05). Results Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) −15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI −11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain ( p  &lt; 0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups ( p  &lt; 0.001). Conclusion TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.</description><identifier>ISSN: 0937-3462</identifier><identifier>EISSN: 1433-3023</identifier><identifier>DOI: 10.1007/s00192-012-1998-2</identifier><identifier>PMID: 23208003</identifier><language>eng</language><publisher>London: Springer London</publisher><subject>Adult ; Aged ; Female ; Follow-Up Studies ; Gynecologic Surgical Procedures - methods ; Gynecology ; Humans ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Original Article ; Prospective Studies ; Quality of Life ; Suburethral Slings - classification ; Surveys and Questionnaires ; Treatment Outcome ; Urinary Incontinence, Stress - physiopathology ; Urinary Incontinence, Stress - surgery ; Urodynamics - physiology ; Urology</subject><ispartof>International Urogynecology Journal, 2013-09, Vol.24 (9), p.1459-1465</ispartof><rights>The International Urogynecological Association 2012</rights><rights>The International Urogynecological Association 2013</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-83b5ff6ec11b91731c5792e2827af6c754c777519c6d39d843381d429a5ecd803</citedby><cites>FETCH-LOGICAL-c372t-83b5ff6ec11b91731c5792e2827af6c754c777519c6d39d843381d429a5ecd803</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23208003$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bianchi-Ferraro, Ana Maria H. M.</creatorcontrib><creatorcontrib>Jarmy-Di Bella, Zsuzsanna I. K.</creatorcontrib><creatorcontrib>Castro, Rodrigo de A.</creatorcontrib><creatorcontrib>Bortolini, Maria Augusta T.</creatorcontrib><creatorcontrib>Sartori, Marair G. F.</creatorcontrib><creatorcontrib>Girão, Manoel J. B. C.</creatorcontrib><title>Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial</title><title>International Urogynecology Journal</title><addtitle>Int Urogynecol J</addtitle><addtitle>Int Urogynecol J</addtitle><description>Introduction and hypothesis We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI). Methods This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O ( n  = 56) or TVT-S ( n  = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King’s Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by &gt;15 %. Statistical significance was fixed at 5 % ( p  &lt; 0.05). Results Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) −15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI −11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain ( p  &lt; 0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups ( p  &lt; 0.001). Conclusion TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.</description><subject>Adult</subject><subject>Aged</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gynecologic Surgical Procedures - methods</subject><subject>Gynecology</subject><subject>Humans</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Original Article</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Suburethral Slings - classification</subject><subject>Surveys and Questionnaires</subject><subject>Treatment Outcome</subject><subject>Urinary Incontinence, Stress - physiopathology</subject><subject>Urinary Incontinence, Stress - surgery</subject><subject>Urodynamics - physiology</subject><subject>Urology</subject><issn>0937-3462</issn><issn>1433-3023</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><recordid>eNp1kUFvFSEUhYmxsc-2P6AbM4mbbtB7YRgGd6axatLERds14TFMSzMDT2BidNWfXibvaYyJKy6c754LHELOEd4hgHyfAVAxCsgoKtVT9oJssOWccmD8JdmA4pLytmPH5HXOjwDQgoBX5JhxBj0A35CnGx_uJ0d9sD77GJo81YPGxnlnkhuaH748NCWZkOO2LMmUmA7IWKuSnCnrJtcq52ZJPpj0s6luMVTBBes-NKap_UOc_a9quAopTlMtS_JmOiVHo5myOzusJ-Tu6tPt5Rd6_e3z18uP19RyyQrt-VaMY-cs4lah5GiFVMyxnkkzdlaK1kopBSrbDVwNff2FHoeWKSOcHXrgJ-Ri77tL8fvictGzz9ZNkwkuLlljyzqBQjCs6Nt_0Me4pFBvt1Ki5YLz1RD3lE0x5-RGvUt-rq_XCHqNR-_j0TUevcajWe15c3BetrMb_nT8zqMCbA_kKoV7l_4a_V_XZ7qKnD0</recordid><startdate>20130901</startdate><enddate>20130901</enddate><creator>Bianchi-Ferraro, Ana Maria H. M.</creator><creator>Jarmy-Di Bella, Zsuzsanna I. K.</creator><creator>Castro, Rodrigo de A.</creator><creator>Bortolini, Maria Augusta T.</creator><creator>Sartori, Marair G. F.</creator><creator>Girão, Manoel J. B. C.</creator><general>Springer London</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope></search><sort><creationdate>20130901</creationdate><title>Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial</title><author>Bianchi-Ferraro, Ana Maria H. M. ; Jarmy-Di Bella, Zsuzsanna I. K. ; Castro, Rodrigo de A. ; Bortolini, Maria Augusta T. ; Sartori, Marair G. F. ; Girão, Manoel J. B. C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-83b5ff6ec11b91731c5792e2827af6c754c777519c6d39d843381d429a5ecd803</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gynecologic Surgical Procedures - methods</topic><topic>Gynecology</topic><topic>Humans</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Middle Aged</topic><topic>Original Article</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Suburethral Slings - classification</topic><topic>Surveys and Questionnaires</topic><topic>Treatment Outcome</topic><topic>Urinary Incontinence, Stress - physiopathology</topic><topic>Urinary Incontinence, Stress - surgery</topic><topic>Urodynamics - physiology</topic><topic>Urology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bianchi-Ferraro, Ana Maria H. M.</creatorcontrib><creatorcontrib>Jarmy-Di Bella, Zsuzsanna I. K.</creatorcontrib><creatorcontrib>Castro, Rodrigo de A.</creatorcontrib><creatorcontrib>Bortolini, Maria Augusta T.</creatorcontrib><creatorcontrib>Sartori, Marair G. F.</creatorcontrib><creatorcontrib>Girão, Manoel J. B. C.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health Medical collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><jtitle>International Urogynecology Journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bianchi-Ferraro, Ana Maria H. M.</au><au>Jarmy-Di Bella, Zsuzsanna I. K.</au><au>Castro, Rodrigo de A.</au><au>Bortolini, Maria Augusta T.</au><au>Sartori, Marair G. F.</au><au>Girão, Manoel J. B. C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial</atitle><jtitle>International Urogynecology Journal</jtitle><stitle>Int Urogynecol J</stitle><addtitle>Int Urogynecol J</addtitle><date>2013-09-01</date><risdate>2013</risdate><volume>24</volume><issue>9</issue><spage>1459</spage><epage>1465</epage><pages>1459-1465</pages><issn>0937-3462</issn><eissn>1433-3023</eissn><abstract>Introduction and hypothesis We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI). Methods This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O ( n  = 56) or TVT-S ( n  = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King’s Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by &gt;15 %. Statistical significance was fixed at 5 % ( p  &lt; 0.05). Results Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) −15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI −11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain ( p  &lt; 0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups ( p  &lt; 0.001). Conclusion TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.</abstract><cop>London</cop><pub>Springer London</pub><pmid>23208003</pmid><doi>10.1007/s00192-012-1998-2</doi><tpages>7</tpages></addata></record>
fulltext fulltext
identifier ISSN: 0937-3462
ispartof International Urogynecology Journal, 2013-09, Vol.24 (9), p.1459-1465
issn 0937-3462
1433-3023
language eng
recordid cdi_proquest_miscellaneous_1426515521
source Springer Nature
subjects Adult
Aged
Female
Follow-Up Studies
Gynecologic Surgical Procedures - methods
Gynecology
Humans
Medicine
Medicine & Public Health
Middle Aged
Original Article
Prospective Studies
Quality of Life
Suburethral Slings - classification
Surveys and Questionnaires
Treatment Outcome
Urinary Incontinence, Stress - physiopathology
Urinary Incontinence, Stress - surgery
Urodynamics - physiology
Urology
title Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-29T12%3A43%3A38IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Single-incision%20sling%20compared%20with%20transobturator%20sling%20for%20treating%20stress%20urinary%20incontinence:%20a%20randomized%20controlled%20trial&rft.jtitle=International%20Urogynecology%20Journal&rft.au=Bianchi-Ferraro,%20Ana%20Maria%20H.%20M.&rft.date=2013-09-01&rft.volume=24&rft.issue=9&rft.spage=1459&rft.epage=1465&rft.pages=1459-1465&rft.issn=0937-3462&rft.eissn=1433-3023&rft_id=info:doi/10.1007/s00192-012-1998-2&rft_dat=%3Cproquest_cross%3E3047442961%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c372t-83b5ff6ec11b91731c5792e2827af6c754c777519c6d39d843381d429a5ecd803%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=1425435330&rft_id=info:pmid/23208003&rfr_iscdi=true