Adjustable mini‐sling compared with conventional mid‐urethral slings in women with urinary incontinence. A?randomized controlled trial

Rudnicki Martin; Bothmer‐Ostling Katarina; Holstad Anja; Magnusson Claes; Majida Memona; Merkel Constanze; Prien Jens; Jakobsson Ulf; Teleman Pia

摘要

Abstract <section xml:id="aogs13205-sec-0001"> <title type="main">Introduction > The primary aim of this study was to compare the objective and subjective outcomes and short‐term complication rates of an adjustable single‐incision mini‐sling ( <fc>SIMS</fc> ) vs. standard mid‐urethral slings ( <fc>SMUS</fc> ). The secondary aim was to report pain perception and complications at the one‐year follow up. </section> <section xml:id="aogs13205-sec-0002"> <title type="main">Material and methods > The study was designed as a multicenter prospective randomized trial where women were included from eight centers in Denmark, Norway and Sweden. The trial was registered at ClinicalTrials.gov: <fc>NCT</fc> 01754558. A total of 305 women less than 60?years old with verified stress urinary incontinence were included. All women were randomized to <fc>SIMS</fc> (Ajust ? ; n? = ? 155) or <fc>SMUS</fc> ( <fc>TVT</fc> , <fc>TVT</fc> ‐O or <fc>TOT</fc> ; n? = ? 150) and were evaluated by stress test and bladder diary before and after surgery and symptoms related to incontinence using <fc>ICIQ</fc> ‐ <fc>SF</fc> , <fc>PISQ</fc> ‐12 and <fc>PGI</fc> ‐S and <fc>PGI</fc> ‐I. Objective cure was defined as no leakage during a stress test and subjective cure defined as no leakage stated in the bladder diary or no indication of urinary leakage in the <fc>ICIQ</fc> ‐ <fc>SF</fc> . Furthermore, mesh exposure and dyspareunia were recorded. </section> <section xml:id="aogs13205-sec-0003"> <title type="main">Results > In total, 280 women [141 (91%) in the <fc>SIMS</fc> and 139 (94%) in the <fc>SMUS</fc> groups] participated in the one‐year follow up. No difference between the groups was observed regarding objective and subjective outcomes. <fc>VAS</fc> score disclosed a lower postoperative pain perception in the <fc>SIMS</fc> group than in the <fc>SMUS</fc> group. </section> <section xml:id="aogs13205-sec-0004"> <title type="main">Conclusions > Ajust ? appears to be as efficient as <fc>SMUS</fc> regarding objective and subjective outcomes and was associated with less pain perception during the postoperative period. </section> </abstract> </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> <div class="translation abstracttxt"> <span class="zhankaihshouqi fivelineshidden" id="abstract"> <span>机译：</span><abstract xmlns =“http://www.wiley.com/namespaces/wiley”type =“main”xml：id =“aogs13205-abs-0001”> <标题类型=“main”>抽象</ title> <部分XML：ID =“AOGS13205-SEC-0001”> <标题类型=“main”>介绍</ title> >本研究的主要目标是比较目标和主观结果和短期并发症率可调节的单切口迷你吊索（<FC> SIMS </ FC>）与标准中尿道吊索（<FC> SMUS </ FC>）。二次目的是报告一年后的疼痛感知和并发症。 </ p> </ section> <section XML：ID =“AOGS13205-SEC-0002”> <标题类型=“main”>材料和方法</ title> >该研究被设计为多中心前瞻性随机试验妇女在丹麦，挪威和瑞典的八个中心中包含的地方。该试验在ClinicalTrials.gov注册：<FC> NCT </ FC> 01754558.共有305名女性少于60人，包括核实尿失禁的历史。所有妇女随机被随机化为<FC> SIMS </ FC>（ajust 〜</ b> </ sup>; n？n？</ i> = ？</ i> 155 ）或<FC> SMUS </ FC>（<FC> TVT </ FC>，<FC> TVT </ FC> -O或<FC> TOT </ FC>; n？</ i> = ？</ i> 150），并通过手术和膀胱术前后和膀胱术进行评估，并且使用<FC> ICIQ </ FC> - <FC> SF </ FC>，<FC>相关的症状。 PISQ </ FC> -12和<FC> PGI </ FC> -S和<FC> PGI </ FC> -I。在膀胱日记中没有泄漏的应力测试和主观固化期间没有定义物理固化在膀胱日记中没有泄漏的主观固化，或者在<FC> ICIQ </ FC> - <FC> SF>中没有尿泄漏的指示。此外，记录了网状曝光和呼吸困难。 </ p> </ section> <section xml：id =“aogs13205-sec-0003”> <标题类型=“main”>结果</ title> >总共280名女性[141（91％） <FC> SIMS </ FC>和139（94％）在<FC> SMUS </ FC>组中参加了一年的跟进。对客观和主观结果没有观察到群体之间的差异。 <FC> VAS </ FC>分数公开了<FC> SIMS </ FC>组中的术后疼痛感知，而不是<FC> SMUS </ FC>组。 </ p> </ section> <section xml：id =“aogs13205-sec-0004”> <标题类型=“main”>结论</ title> > ajust ？</ b> </ sup>似乎与<fc> smus效率有关目标和主观结果，并且在术后期间与较少的疼痛感染相关。 </ p> </ section> </ abstract> </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> </div> <div class="record"> <h2 class="all_title" id="enpatent33" >著录项</h2> <ul> <li> <span class="lefttit">来源</span> <div style="width: 86%;vertical-align: text-top;display: inline-block;"> <a href='/journal-foreign-17780/'>《Acta Obstetricia et Gynecologica Scandinavica: Official Publication of the Nordisk Forening for Obstetrik och Gynekologi》</a> <b style="margin: 0 2px;">|</b><span>2017年第11期</span><b style="margin: 0 2px;">|</b><span>共10页</span> </div> </li> <li> <div class="author"> <span class="lefttit">作者</span> <p id="fAuthorthree" class="threelineshidden zhankaihshouqi"> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Rudnicki Martin&option=202" target="_blank" rel="nofollow">Rudnicki Martin;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Bothmer‐Ostling Katarina&option=202" target="_blank" rel="nofollow">Bothmer‐Ostling Katarina;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Holstad Anja&option=202" target="_blank" rel="nofollow">Holstad Anja;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Magnusson Claes&option=202" target="_blank" rel="nofollow">Magnusson Claes;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Majida Memona&option=202" target="_blank" rel="nofollow">Majida Memona;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Merkel Constanze&option=202" target="_blank" rel="nofollow">Merkel Constanze;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Prien Jens&option=202" target="_blank" rel="nofollow">Prien Jens;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Jakobsson Ulf&option=202" target="_blank" rel="nofollow">Jakobsson Ulf;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Teleman Pia&option=202" target="_blank" rel="nofollow">Teleman Pia;</a> </p> <span class="z_kbtnclass z_kbtnclassall hoverxs" id="zkzz" style="display: none;">展开▼</span> </div> </li> <li> <div style="display: flex;"> <span class="lefttit">作者单位</span> <div style="position: relative;margin-left: 3px;max-width: 639px;"> <div class="threelineshidden zhankaihshouqi" id="fOrgthree"> <p>Department of Obstetrics and GynecologyOdense University HospitalOdense Denmark;</p> <p>Department of Obstetrics and GynecologyHalmstad HospitalHalmstad Sweden;</p> <p>Department of Obstetrics and GynecologyGj?vik HospitalGj?vik Norway;</p> <p>Department of Obstetrics and GynecologySahlgrenska University HospitalGothenburg Sweden;</p> <p>Department of Obstetrics and GynecologyAhus University HospitalOslo Norway;</p> <p>Department of Obstetrics and GynecologyRegional Hospital of Northern JutlandFrederikshavn Denmark;</p> <p>Department of Obstetrics and GynecologyZealand HospitalNyk?bing Falster Denmark;</p> <p>Center for Primary Healthcare ResearchUniversity of LundLund Sweden;</p> <p>Department of Obstetrics and GynecologySk?ne University HospitalLund Sweden;</p> </div> <span class="z_kbtnclass z_kbtnclassall hoverxs" id="zhdw" style="display: none;">展开▼</span> </div> </div> </li> <li > <span class="lefttit">收录信息</span> <span style="width: 86%;vertical-align: text-top;display: inline-block;"></span> </li> <li> <span class="lefttit">原文格式</span> <span>PDF</span> </li> <li> <span class="lefttit">正文语种</span> <span>eng</span> </li> <li> <span class="lefttit">中图分类</span> <span><a href="https://www.zhangqiaokeyan.com/clc/197.html" title="妇产科学">妇产科学;</a></span> </li> <li class="antistop"> <span class="lefttit">关键词</span> <p style="width: 86%;vertical-align: text-top;"> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Mini‐sling&option=203" rel="nofollow">Mini‐sling;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=mid‐urethral sling&option=203" rel="nofollow">mid‐urethral sling;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=single‐incision mini‐sling&option=203" rel="nofollow">single‐incision mini‐sling;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=standard mid‐urethral slings&option=203" rel="nofollow">standard mid‐urethral slings;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=stress urinary incontinence&option=203" rel="nofollow">stress urinary incontinence;</a> </p> <div class="translation"> 机译：迷你吊索;中尿道吊索;单切口迷你吊索;标准中尿道吊索;压力尿失禁; </div> </li> </ul> </div> </div> <div class="literature cardcommon"> <div class="similarity "> <h3 class="all_title" id="enpatent66">相似文献</h3> <div class="similaritytab clearfix"> <ul> <li class="active" >外文文献</li> <li >中文文献</li> <li >专利</li> </ul> </div> <div class="similarity_details"> <ul > <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/journal-foreign-detail/0704023853525.html">ADJUSTABLE MINI-SLING COMPARED TO 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tuijian_authcolor">,杨柳风</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=霍竹惠&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,霍竹惠</a> <span> <a href="/journal-cn-10968/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 广东医学 </a> </span> <span> . 2014</span><span>,第020期</span> </span> </div> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/academic-journal-cn_henan-journal-surgery_thesis/0201279871807.html">自制可调节吊带用于经耻骨后路经阴道无张力尿道中段悬吊术治疗女性压力性尿失禁的近期效果</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=马志远&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 马志远</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=李园&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,李园</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=武跃清&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,武跃清</a> <span> <a href="/journal-cn-6065/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 河南外科学杂志 </a> </span> <span> . 2020</span><span>,第005期</span> </span> </div> </li> <li> <div> <b>4. </b><a class="enjiyixqcontent" href="/academic-journal-cn_international-medicine-health-guidance-news_thesis/0201232172599.html">可调节单切口尿道中段吊带术联合温针灸Kegel锻炼治疗女性压力性尿失禁的疗效观察</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=李冠军&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 李冠军</a> <span> <a href="/journal-cn-11055/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 国际医药卫生导报 </a> </span> <span> . 2017</span><span>,第018期</span> </span> </div> </li> <li> <div> <b>5. </b><a class="enjiyixqcontent" href="/academic-journal-cn_journal-modern-urology_thesis/0201233782899.html">可调节单切口尿道中段吊带术治疗女性压力性尿失禁的临床疗效与安全性分析</a> <b>[J]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=王劲夫&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 王劲夫</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=王建业&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,王建业</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=万奔&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor">,万奔</a> <span> <a href="/journal-cn-6090/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 现代泌尿外科杂志 </a> </span> <span> . 2016</span><span>,第003期</span> </span> </div> </li> <li> <div> <b>6. </b><a class="enjiyixqcontent" href="/academic-conference-cn_meeting-5023_thesis/020221257151.html">单切口经阴道无张力尿道中段悬吊带术TVT-Secur治疗女性压力性尿失禁前瞻性研究</a> <b>[C]</b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=孙之星&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 孙之星</a> <span> <a href="/conference-cn-5023/" target="_blank" rel="nofollow" class="tuijian_authcolor"> . 第二届北京市大学生科学研究与创业行动计划成果展示与经验交流会 </a> <span> <span> . 2013</span> </span> </div> </li> <li> <div> <b>7. </b><a class="enjiyixqcontent" href="/academic-degree-domestic_mphd_thesis/020314761482.html">尿道中段吊带术治疗女性混合性尿失禁的临床分析</a> <b>[A] </b> <span> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=周煦东&option=202" target="_blank" rel="nofollow" class="tuijian_auth tuijian_authcolor"> . 周煦东</a> <span> . 2013</span> </span> </div> </li> </ul> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/patent-detail/06120113358432.html">一种尿失禁尿道吊带术用钳</a> <b>[P]</b> . <span> 中国专利： CN113384321A </span> <span> . 2021-09-14</span> </div> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/patent-detail/06120206699183.html">一种尿失禁尿道吊带术专用钳</a> <b>[P]</b> . <span> 中国专利： CN206700198U </span> <span> . 2017-12-05</span> </div> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/patent-detail/06130407398824.html">METHOD OF TREATING URINARY INCONTINENCE BY IMPLANTING A TRANSVAGINAL MID-URETHRAL SLING INTO A PERSON</a> <b>[P]</b> . <span> 外国专利：  US2018071070A1 </span> <span> . 2018-03-15</span> </div> <p class="zwjiyix translation" style="max-width: initial;height: auto;word-break: break-all;white-space: initial;text-overflow: initial;overflow: initial;"> <span>机译：通过将经阴道中尿道吊带植入人内来治疗尿不定的方法 </span> </p> </li> <li> <div> <b>4. </b><a class="enjiyixqcontent" href="/patent-detail/06130427667160.html">Surgical apparatus for delivering a sling for treating female urinary incontinence.</a> <b>[P]</b> . <span> 外国专利：  ES2336427T3 </span> <span> . 2010-04-13</span> </div> <p class="zwjiyix translation" style="max-width: initial;height: auto;word-break: break-all;white-space: initial;text-overflow: initial;overflow: initial;"> <span>机译：用于输送用于治疗女性尿失禁的悬带的手术设备。 </span> </p> </li> <li> <div> <b>5. </b><a class="enjiyixqcontent" href="/patent-detail/06130430128673.html">Apparatus for measuring and evaluating the voltage sling for treating female urinary incontinence.</a> <b>[P]</b> . <span> 外国专利：  ES2316488T3 </span> <span> . 2009-04-16</span> </div> <p class="zwjiyix translation" style="max-width: initial;height: auto;word-break: break-all;white-space: initial;text-overflow: initial;overflow: initial;"> <span>机译：用于测量和评估用于治疗女性尿失禁的电压悬带的设备。 </span> </p> </li> </ul> </div> </div> </div> <div class="theme cardcommon" style="overflow: auto;display:none"> <h3 class="all_title" id="enpatent55">相关主题</h3> <ul id="subject"> </ul> </div> </div> </div> </div> <div class="right rightcon"> <div class="details_img cardcommon clearfix" style="margin-bottom: 10px;display:none;" > </div> </div> </div> <div id="thesis_get_original1" class="downloadBth" style="bottom: 19px;z-index: 999;" onclick="ywcd('0704022405009','4',7,2,1,'',this,24)" class="delivery" prompt="010401" title="通过人工服务将文献原文发送至邮箱" >获取原文</div> <div 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