Long‐term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid‐urethral slings: a prospective observational study
Objective There are concerns regarding the risks of mid‐urethral slings (MUS) for stress urinary incontinence (SUI), particularly because of the lack of long‐term data. We compare patient‐reported outcomes of a multicentre randomised controlled trial of retropubic (TVT, GYNECARE™) versus transobtura...
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Veröffentlicht in: | BJOG : an international journal of obstetrics and gynaecology 2021-12, Vol.128 (13), p.2191-2199 |
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creator | Offiah, I Freeman, R Offiah, I Freeman, R Waterfield, M Lochhead, K Hillard, T Madhu, C Sultan, A James, M Foley, S Buckley, S Speaksman, M Reid, F Abrams, P |
description | Objective
There are concerns regarding the risks of mid‐urethral slings (MUS) for stress urinary incontinence (SUI), particularly because of the lack of long‐term data. We compare patient‐reported outcomes of a multicentre randomised controlled trial of retropubic (TVT, GYNECARE™) versus transobturator (TOT, MONARC™) tape surgery at 12 years.
Design and setting
A multicentre study was performed in 11 tertiary referral centres.
Population
A cohort of 180 participants from the original trial, the majority of whom had mixed urinary incontinence.
Methods
Postal questionnaire survey of patient‐reported outcome measures using the International Consultation on Incontinence Questionnaire, Patient Global Impression of Improvement questionnaire (PGI‐I) and a numeric rating scale pain questionnaire.
Main outcome measures
Comparison of the efficacy and complications between the TVT and TOT procedures in the long term.
Results
A total of 110/180 responses were received: 55 for TVT and 55 for TOT. The mean follow‐up was 12.8 ± 0.29 years (SD). TVT was significantly superior to TOT: 41.8% TVT with no SUI, versus 21.8% TOT (P = 0.04). Urgency urinary incontinence (UUI) was the most bothersome urinary symptom: 14.5% of respondents reported UUI after TVT and TOT. This was an improvement from the baseline levels: 61.8% TVT and 76.4% TOT. Seventeen patients (9 TVT and 8 TOT) out of 121 reported moderate or severe pain with severe pain in 3 with TVT and 2 with TOT. Overall, 80% TVT and 77% TOT participants reported their symptoms as improved on the PGI‐I.
Conclusions
TVT is superior to TOT for SUI cure. Efficacy is reduced by 12 years. There is low incidence of severe vaginal or groin pain. Careful patient counselling on long‐term outcomes is required. The Retropubic tape appears to be an effective treatment for the majority of women with SUI.
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Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates.
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Retropubic tape has superior efficacy to transobturator tape. Complications are comparable and uncommon. |
doi_str_mv | 10.1111/1471-0528.16899 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2569380821</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2569380821</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4129-3f80c755320086101144ab29d3c528e4573bda09489cd6904481b801749a3663</originalsourceid><addsrcrecordid>eNqFkb1u1jAUhiMEoqUwsyFLLF3S-i-OzQYVv_qkLt0tx3GKKycOttPq27iEXgxXxJVwkq90YMGL_573Pcd-q-o1wWcExjnhLalxQ-UZEVKpJ9Xx48nTbY1rzKg8ql7kfIMxERSz59UR47yVAvPj6tcuTte_f94Xl0bkhsFbY_fITD2ycZwDbIuPU0ZxQAaNSyjeuqkkhxIwcfTZrSScxBBgWZI3YZOa5KdrlBzczEvn7eZZQJVjV5ZkSkxo9D2UXgD6nkCWA0jyOyg0p5hnZ4u_dSh22aXbrY2VKUu_f1k9G0zI7tXDfFJdffp4dfGl3l1-_nrxfldbTqiq2SCxbZuGUYylIJgQzk1HVc8s_I_jTcu63mDFpbK9UJhzSTqJScuVYUKwk-r0YAvt_FhcLhrea10IZnJxyZo2QjGJJSWAvv0HvYlLgoaBEphIThpKgTo_UBbel5Mb9Jz8aNJeE6zXPPWanl7T01ueoHjz4Lt0o-sf-b8BAtAcgDsf3P5_fvrDt8uD8R9x2K9I</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2601841522</pqid></control><display><type>article</type><title>Long‐term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid‐urethral slings: a prospective observational study</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Offiah, I ; Freeman, R ; Offiah, I ; Freeman, R ; Waterfield, M ; Lochhead, K ; Hillard, T ; Madhu, C ; Sultan, A ; James, M ; Foley, S ; Buckley, S ; Speaksman, M ; Reid, F ; Abrams, P</creator><creatorcontrib>Offiah, I ; Freeman, R ; Offiah, I ; Freeman, R ; Waterfield, M ; Lochhead, K ; Hillard, T ; Madhu, C ; Sultan, A ; James, M ; Foley, S ; Buckley, S ; Speaksman, M ; Reid, F ; Abrams, P ; MONARC™ study group ; for the MONARC™ study group</creatorcontrib><description>Objective
There are concerns regarding the risks of mid‐urethral slings (MUS) for stress urinary incontinence (SUI), particularly because of the lack of long‐term data. We compare patient‐reported outcomes of a multicentre randomised controlled trial of retropubic (TVT, GYNECARE™) versus transobturator (TOT, MONARC™) tape surgery at 12 years.
Design and setting
A multicentre study was performed in 11 tertiary referral centres.
Population
A cohort of 180 participants from the original trial, the majority of whom had mixed urinary incontinence.
Methods
Postal questionnaire survey of patient‐reported outcome measures using the International Consultation on Incontinence Questionnaire, Patient Global Impression of Improvement questionnaire (PGI‐I) and a numeric rating scale pain questionnaire.
Main outcome measures
Comparison of the efficacy and complications between the TVT and TOT procedures in the long term.
Results
A total of 110/180 responses were received: 55 for TVT and 55 for TOT. The mean follow‐up was 12.8 ± 0.29 years (SD). TVT was significantly superior to TOT: 41.8% TVT with no SUI, versus 21.8% TOT (P = 0.04). Urgency urinary incontinence (UUI) was the most bothersome urinary symptom: 14.5% of respondents reported UUI after TVT and TOT. This was an improvement from the baseline levels: 61.8% TVT and 76.4% TOT. Seventeen patients (9 TVT and 8 TOT) out of 121 reported moderate or severe pain with severe pain in 3 with TVT and 2 with TOT. Overall, 80% TVT and 77% TOT participants reported their symptoms as improved on the PGI‐I.
Conclusions
TVT is superior to TOT for SUI cure. Efficacy is reduced by 12 years. There is low incidence of severe vaginal or groin pain. Careful patient counselling on long‐term outcomes is required. The Retropubic tape appears to be an effective treatment for the majority of women with SUI.
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Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates.
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Retropubic tape has superior efficacy to transobturator tape. Complications are comparable and uncommon.</description><identifier>ISSN: 1470-0328</identifier><identifier>EISSN: 1471-0528</identifier><identifier>DOI: 10.1111/1471-0528.16899</identifier><identifier>PMID: 34478604</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Clinical trials ; Complications ; Female ; Gynecologic Surgical Procedures - methods ; Gynecologic Surgical Procedures - statistics & numerical data ; Humans ; long‐term patient‐reported outcomes ; Middle Aged ; Observational studies ; Pain ; Patient Reported Outcome Measures ; Patients ; Prospective Studies ; Questionnaires ; retropubic mid‐urethral sling ; stress urinary incontinence ; Suburethral Slings - classification ; Suburethral Slings - statistics & numerical data ; Surgical outcomes ; Surgical techniques ; Surveys and Questionnaires ; transobturator mid‐urethral sling ; Treatment Outcome ; Urinary incontinence ; Urinary Incontinence, Stress - etiology ; Urinary Incontinence, Stress - surgery ; Urologic Surgical Procedures - methods ; Urological surgery ; Womens health</subject><ispartof>BJOG : an international journal of obstetrics and gynaecology, 2021-12, Vol.128 (13), p.2191-2199</ispartof><rights>2021 John Wiley & Sons Ltd.</rights><rights>Copyright © 2021 Royal College of Obstetricians and Gynaecologists</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4129-3f80c755320086101144ab29d3c528e4573bda09489cd6904481b801749a3663</citedby><cites>FETCH-LOGICAL-c4129-3f80c755320086101144ab29d3c528e4573bda09489cd6904481b801749a3663</cites><orcidid>0000-0002-3233-9848</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2F1471-0528.16899$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2F1471-0528.16899$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34478604$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Offiah, I</creatorcontrib><creatorcontrib>Freeman, R</creatorcontrib><creatorcontrib>Offiah, I</creatorcontrib><creatorcontrib>Freeman, R</creatorcontrib><creatorcontrib>Waterfield, M</creatorcontrib><creatorcontrib>Lochhead, K</creatorcontrib><creatorcontrib>Hillard, T</creatorcontrib><creatorcontrib>Madhu, C</creatorcontrib><creatorcontrib>Sultan, A</creatorcontrib><creatorcontrib>James, M</creatorcontrib><creatorcontrib>Foley, S</creatorcontrib><creatorcontrib>Buckley, S</creatorcontrib><creatorcontrib>Speaksman, M</creatorcontrib><creatorcontrib>Reid, F</creatorcontrib><creatorcontrib>Abrams, P</creatorcontrib><creatorcontrib>MONARC™ study group</creatorcontrib><creatorcontrib>for the MONARC™ study group</creatorcontrib><title>Long‐term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid‐urethral slings: a prospective observational study</title><title>BJOG : an international journal of obstetrics and gynaecology</title><addtitle>BJOG</addtitle><description>Objective
There are concerns regarding the risks of mid‐urethral slings (MUS) for stress urinary incontinence (SUI), particularly because of the lack of long‐term data. We compare patient‐reported outcomes of a multicentre randomised controlled trial of retropubic (TVT, GYNECARE™) versus transobturator (TOT, MONARC™) tape surgery at 12 years.
Design and setting
A multicentre study was performed in 11 tertiary referral centres.
Population
A cohort of 180 participants from the original trial, the majority of whom had mixed urinary incontinence.
Methods
Postal questionnaire survey of patient‐reported outcome measures using the International Consultation on Incontinence Questionnaire, Patient Global Impression of Improvement questionnaire (PGI‐I) and a numeric rating scale pain questionnaire.
Main outcome measures
Comparison of the efficacy and complications between the TVT and TOT procedures in the long term.
Results
A total of 110/180 responses were received: 55 for TVT and 55 for TOT. The mean follow‐up was 12.8 ± 0.29 years (SD). TVT was significantly superior to TOT: 41.8% TVT with no SUI, versus 21.8% TOT (P = 0.04). Urgency urinary incontinence (UUI) was the most bothersome urinary symptom: 14.5% of respondents reported UUI after TVT and TOT. This was an improvement from the baseline levels: 61.8% TVT and 76.4% TOT. Seventeen patients (9 TVT and 8 TOT) out of 121 reported moderate or severe pain with severe pain in 3 with TVT and 2 with TOT. Overall, 80% TVT and 77% TOT participants reported their symptoms as improved on the PGI‐I.
Conclusions
TVT is superior to TOT for SUI cure. Efficacy is reduced by 12 years. There is low incidence of severe vaginal or groin pain. Careful patient counselling on long‐term outcomes is required. The Retropubic tape appears to be an effective treatment for the majority of women with SUI.
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Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates.
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Retropubic tape has superior efficacy to transobturator tape. Complications are comparable and uncommon.</description><subject>Clinical trials</subject><subject>Complications</subject><subject>Female</subject><subject>Gynecologic Surgical Procedures - methods</subject><subject>Gynecologic Surgical Procedures - statistics & numerical data</subject><subject>Humans</subject><subject>long‐term patient‐reported outcomes</subject><subject>Middle Aged</subject><subject>Observational studies</subject><subject>Pain</subject><subject>Patient Reported Outcome Measures</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Questionnaires</subject><subject>retropubic mid‐urethral sling</subject><subject>stress urinary incontinence</subject><subject>Suburethral Slings - classification</subject><subject>Suburethral Slings - statistics & numerical data</subject><subject>Surgical outcomes</subject><subject>Surgical techniques</subject><subject>Surveys and Questionnaires</subject><subject>transobturator mid‐urethral sling</subject><subject>Treatment Outcome</subject><subject>Urinary incontinence</subject><subject>Urinary Incontinence, Stress - etiology</subject><subject>Urinary Incontinence, Stress - surgery</subject><subject>Urologic Surgical Procedures - methods</subject><subject>Urological surgery</subject><subject>Womens health</subject><issn>1470-0328</issn><issn>1471-0528</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkb1u1jAUhiMEoqUwsyFLLF3S-i-OzQYVv_qkLt0tx3GKKycOttPq27iEXgxXxJVwkq90YMGL_573Pcd-q-o1wWcExjnhLalxQ-UZEVKpJ9Xx48nTbY1rzKg8ql7kfIMxERSz59UR47yVAvPj6tcuTte_f94Xl0bkhsFbY_fITD2ycZwDbIuPU0ZxQAaNSyjeuqkkhxIwcfTZrSScxBBgWZI3YZOa5KdrlBzczEvn7eZZQJVjV5ZkSkxo9D2UXgD6nkCWA0jyOyg0p5hnZ4u_dSh22aXbrY2VKUu_f1k9G0zI7tXDfFJdffp4dfGl3l1-_nrxfldbTqiq2SCxbZuGUYylIJgQzk1HVc8s_I_jTcu63mDFpbK9UJhzSTqJScuVYUKwk-r0YAvt_FhcLhrea10IZnJxyZo2QjGJJSWAvv0HvYlLgoaBEphIThpKgTo_UBbel5Mb9Jz8aNJeE6zXPPWanl7T01ueoHjz4Lt0o-sf-b8BAtAcgDsf3P5_fvrDt8uD8R9x2K9I</recordid><startdate>202112</startdate><enddate>202112</enddate><creator>Offiah, I</creator><creator>Freeman, R</creator><creator>Offiah, I</creator><creator>Freeman, R</creator><creator>Waterfield, M</creator><creator>Lochhead, K</creator><creator>Hillard, T</creator><creator>Madhu, C</creator><creator>Sultan, A</creator><creator>James, M</creator><creator>Foley, S</creator><creator>Buckley, S</creator><creator>Speaksman, M</creator><creator>Reid, F</creator><creator>Abrams, P</creator><general>Wiley Subscription Services, Inc</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>7QP</scope><scope>ASE</scope><scope>FPQ</scope><scope>K6X</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-3233-9848</orcidid></search><sort><creationdate>202112</creationdate><title>Long‐term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid‐urethral slings: a prospective observational study</title><author>Offiah, I ; Freeman, R ; Offiah, I ; Freeman, R ; Waterfield, M ; Lochhead, K ; Hillard, T ; Madhu, C ; Sultan, A ; James, M ; Foley, S ; Buckley, S ; Speaksman, M ; Reid, F ; Abrams, P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4129-3f80c755320086101144ab29d3c528e4573bda09489cd6904481b801749a3663</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Clinical trials</topic><topic>Complications</topic><topic>Female</topic><topic>Gynecologic Surgical Procedures - methods</topic><topic>Gynecologic Surgical Procedures - statistics & numerical data</topic><topic>Humans</topic><topic>long‐term patient‐reported outcomes</topic><topic>Middle Aged</topic><topic>Observational studies</topic><topic>Pain</topic><topic>Patient Reported Outcome Measures</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>Questionnaires</topic><topic>retropubic mid‐urethral sling</topic><topic>stress urinary incontinence</topic><topic>Suburethral Slings - classification</topic><topic>Suburethral Slings - statistics & numerical data</topic><topic>Surgical outcomes</topic><topic>Surgical techniques</topic><topic>Surveys and Questionnaires</topic><topic>transobturator mid‐urethral sling</topic><topic>Treatment Outcome</topic><topic>Urinary incontinence</topic><topic>Urinary Incontinence, Stress - etiology</topic><topic>Urinary Incontinence, Stress - surgery</topic><topic>Urologic Surgical Procedures - methods</topic><topic>Urological surgery</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Offiah, I</creatorcontrib><creatorcontrib>Freeman, R</creatorcontrib><creatorcontrib>Offiah, I</creatorcontrib><creatorcontrib>Freeman, R</creatorcontrib><creatorcontrib>Waterfield, M</creatorcontrib><creatorcontrib>Lochhead, K</creatorcontrib><creatorcontrib>Hillard, T</creatorcontrib><creatorcontrib>Madhu, C</creatorcontrib><creatorcontrib>Sultan, A</creatorcontrib><creatorcontrib>James, M</creatorcontrib><creatorcontrib>Foley, S</creatorcontrib><creatorcontrib>Buckley, S</creatorcontrib><creatorcontrib>Speaksman, M</creatorcontrib><creatorcontrib>Reid, F</creatorcontrib><creatorcontrib>Abrams, P</creatorcontrib><creatorcontrib>MONARC™ study group</creatorcontrib><creatorcontrib>for the MONARC™ study group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>BJOG : an international journal of obstetrics and gynaecology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Offiah, I</au><au>Freeman, R</au><au>Offiah, I</au><au>Freeman, R</au><au>Waterfield, M</au><au>Lochhead, K</au><au>Hillard, T</au><au>Madhu, C</au><au>Sultan, A</au><au>James, M</au><au>Foley, S</au><au>Buckley, S</au><au>Speaksman, M</au><au>Reid, F</au><au>Abrams, P</au><aucorp>MONARC™ study group</aucorp><aucorp>for the MONARC™ study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long‐term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid‐urethral slings: a prospective observational study</atitle><jtitle>BJOG : an international journal of obstetrics and gynaecology</jtitle><addtitle>BJOG</addtitle><date>2021-12</date><risdate>2021</risdate><volume>128</volume><issue>13</issue><spage>2191</spage><epage>2199</epage><pages>2191-2199</pages><issn>1470-0328</issn><eissn>1471-0528</eissn><abstract>Objective
There are concerns regarding the risks of mid‐urethral slings (MUS) for stress urinary incontinence (SUI), particularly because of the lack of long‐term data. We compare patient‐reported outcomes of a multicentre randomised controlled trial of retropubic (TVT, GYNECARE™) versus transobturator (TOT, MONARC™) tape surgery at 12 years.
Design and setting
A multicentre study was performed in 11 tertiary referral centres.
Population
A cohort of 180 participants from the original trial, the majority of whom had mixed urinary incontinence.
Methods
Postal questionnaire survey of patient‐reported outcome measures using the International Consultation on Incontinence Questionnaire, Patient Global Impression of Improvement questionnaire (PGI‐I) and a numeric rating scale pain questionnaire.
Main outcome measures
Comparison of the efficacy and complications between the TVT and TOT procedures in the long term.
Results
A total of 110/180 responses were received: 55 for TVT and 55 for TOT. The mean follow‐up was 12.8 ± 0.29 years (SD). TVT was significantly superior to TOT: 41.8% TVT with no SUI, versus 21.8% TOT (P = 0.04). Urgency urinary incontinence (UUI) was the most bothersome urinary symptom: 14.5% of respondents reported UUI after TVT and TOT. This was an improvement from the baseline levels: 61.8% TVT and 76.4% TOT. Seventeen patients (9 TVT and 8 TOT) out of 121 reported moderate or severe pain with severe pain in 3 with TVT and 2 with TOT. Overall, 80% TVT and 77% TOT participants reported their symptoms as improved on the PGI‐I.
Conclusions
TVT is superior to TOT for SUI cure. Efficacy is reduced by 12 years. There is low incidence of severe vaginal or groin pain. Careful patient counselling on long‐term outcomes is required. The Retropubic tape appears to be an effective treatment for the majority of women with SUI.
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Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates.
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Retropubic tape has superior efficacy to transobturator tape. Complications are comparable and uncommon.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>34478604</pmid><doi>10.1111/1471-0528.16899</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-3233-9848</orcidid><oa>free_for_read</oa></addata></record> |
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language | eng |
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source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
subjects | Clinical trials Complications Female Gynecologic Surgical Procedures - methods Gynecologic Surgical Procedures - statistics & numerical data Humans long‐term patient‐reported outcomes Middle Aged Observational studies Pain Patient Reported Outcome Measures Patients Prospective Studies Questionnaires retropubic mid‐urethral sling stress urinary incontinence Suburethral Slings - classification Suburethral Slings - statistics & numerical data Surgical outcomes Surgical techniques Surveys and Questionnaires transobturator mid‐urethral sling Treatment Outcome Urinary incontinence Urinary Incontinence, Stress - etiology Urinary Incontinence, Stress - surgery Urologic Surgical Procedures - methods Urological surgery Womens health |
title | Long‐term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid‐urethral slings: a prospective observational study |
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