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
Hauptverfasser: 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
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container_end_page 2199
container_issue 13
container_start_page 2191
container_title BJOG : an international journal of obstetrics and gynaecology
container_volume 128
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. Tweetable Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates. Tweetable Retropubic tape has superior efficacy to transobturator tape. Complications are comparable and uncommon.
doi_str_mv 10.1111/1471-0528.16899
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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. Tweetable Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates. Tweetable 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 &amp; 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 &amp; 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 &amp; 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. Tweetable Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates. Tweetable 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 &amp; 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 &amp; 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 &amp; 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 &amp; 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 &amp; 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 &amp; 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. Tweetable Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates. Tweetable 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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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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