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...
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Published in: | International Urogynecology Journal 2013-09, Vol.24 (9), p.1459-1465 |
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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 >15 %. Statistical significance was fixed at 5 % (
p
< 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
< 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
< 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 & 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 >15 %. Statistical significance was fixed at 5 % (
p
< 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
< 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
< 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 & 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 & 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 & Medical Complete (Alumni)</collection><collection>Health & 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 >15 %. Statistical significance was fixed at 5 % (
p
< 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
< 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
< 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> |
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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 |
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