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      Ambulatory MiniArc Precise Sling under Local Anesthesia for Stress Urinary Incontinence: Feasibility and Outcome

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          Abstract

          Aims:

          The aim of the study is to assess the feasibility of ambulatory stress urinary incontinence (SUI) surgery using the MiniArc Precise single-incision urethral sling without increasing the number of complications.

          Settings and Design:

          This was a retrospective observational study of prospectively collected data carried out in a Tertiary Referral Hospital in Barcelona, Spain.

          Materials and Methods:

          Forty patients diagnosed with SUI or stress predominant mixed urinary incontinence (MUI) treated surgically between November 2011 and November 2013. The MiniArc Precise ® sling was inserted under local anesthesia in the ambulatory setting.

          Statistical Analysis Used:

          Descriptive statistics included frequencies and percentages for categorical variables and mean and range for quantitative variables. The statistical package used was SPSS version 17.0.

          Results:

          Urodynamic studies showed SUI in 78% of cases and stress predominant MUI in 17%. Clinical findings included SUI in 56% of cases and MUI in 44%, with positive stress tests in all participants. The mean intraoperative pain (1–10 Visual Analog Scale) was 2. All patients were satisfied with the use of local anesthesia in the outpatient setting. Perioperative complications did not occur. One case of urinary retention and two cases of urinary tract infection (UTI) developed within this 1 st month after operation and were successfully managed conservatively. Midterm complications included eight cases of UTI and four de novo urge incontinence.

          Conclusions:

          Placement of the MiniArc Precise sling under local anesthesia is a feasible and safe technique, which when carried out by an experienced surgeon allows to be done as an outpatient basis without increasing the rate of postprocedural complications.

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          Most cited references26

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          Two routes of transobturator tape procedures in stress urinary incontinence: a meta-analysis with direct and indirect comparison of randomized trials.

          Philip Toozs-Hobson, Kameshwar Singh, P M Latthe … (2010)
          Therapy (meta-analysis) Level of Evidence 1a. To assess the effectiveness and complications of transobturator tape (inside-out and outside-in, TOT) by means of a systematic review of direct and indirect randomized controlled trials (RCTs). MEDLINE, EMBASE, CINAHL, LILIACS (up to December 2008), CENTRAL (The Cochrane Library, Issue 1, 2009), MetaRegister of Controlled Trials, The National Library for Health, the National Research Register and Google Scholar were searched using various relevant search terms. The citation lists of review articles and included trials were searched and contact with the Correspondence of each included trials was attempted. RCTs which compared the effectiveness of synthetic transobturator (inside-out tape TVTO, or outside-in TOT) with TVT by the retropubic route (Gynecare, Ethicon, Inc., or similar tape by a different company) or with each other for the treatment of stress urinary incontinence (SUI), and in all languages, were included. Two reviewers extracted data on participants' characteristics, study quality, intervention, cure and adverse effects independently. The data were analysed using Review Manager 5 software. There were 12 RCTs that compared TOT with TVT, and 15 that compared TVTO vs TVT for treating SUI. There were four direct comparison RCTs of TVTO vs TOT. When compared at 1-44 months, the subjective (odds ratio 1.16; 95% confidence interval 0.83-1.6) and objective (0.94; 0.66-1.32) cure of TOT was similar to TVT. For TVTO, the subjective (1.06, 0.85-1.33) and objective cure (1.03, 0.77-1.39) was also similar to TVT. Adverse events such as bladder injuries (TOT, odds ratio 0.11, 0.05-0.25; TVTO, 0.15, 0.06-0.35) and haematomas (0.06, 0.01-0.30) were less in the TOT than TVT. Voiding difficulties (TOT, odds ratio 0.61, 0.35-1.07); TVTO, 0.81, 0.48-1.31) were slightly lower in TOT but this was not statistically significant. Groin/thigh pain (TVTO, odds ratio 8.05, 3.78-17.16) and vaginal injuries (TOT, 5.82, 1.85-18.3; TVTO, 1.69, 0.73-3.91) were more common in the transobturator tapes. Mesh erosion in TVTO (0.77, 0.22-2.72) and TOT (1.11, 0.54-2.28) was similar to TVT. The effectiveness data over 6 months available from four direct comparison studies of TVTO vs TOT suggested equivalent results for objective cure (1.06, 0.65-1.73) and subjective cure (1.37, 0.93-2.00). When compared indirectly, TVTO has similar subjective (1.23, 0.83-1.82) and objective cure (0.97, 0.62-1.52) to TOT. On indirect comparison, the de novo risk of urgency was similar in the two groups but voiding difficulties seemed to be less in the inside-out group. The evidence for the equivalent effectiveness of TOT and TVTO when compared with each other is established over the short-term. Bladder injuries and voiding difficulties seem to be less with inside-out tapes on indirect comparison. An adequate long-term follow-up of the RCTs is desirable to establish the long-term continued effectiveness of transobturator tapes.
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            Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications.

            Eileen Lim, Priya Madhuvrata, Tyler Ford … (2011)
            Single-incision mini-slings (SIMS) have been introduced for the treatment of female stress urinary incontinence (SUI); however, concerns have been raised regarding their efficacy. No systematic reviews or meta-analyses have previously assessed these relatively new procedures. To assess the current evidence of effectiveness and safety of SIMS compared with standard midurethral slings (SMUS) (retropubic and transobturator tension-free vaginal tapes) in the management of female SUI. We conducted a literature search from 1996 to January 2011. Meta-analysis of all randomised controlled trials (RCTs) comparing SIMS versus SMUS was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Data were analysed using Rev-Man 5. Primary outcomes were patient-reported and objective cure rates. Secondary outcomes included perioperative complications, quality of life (QoL) changes, and costs to health services. A total of 758 women in nine RCTs with a mean follow-up of 9.5 mo were included. The mean age (52.3 vs 52.1 yr), body mass index (27.4 vs 27.7), and parity (2.4 and 2.4) were comparable for both groups. SIMS were associated with significantly lower patient-reported and objective cure rates at 6-12 mo compared with SMUS (risk ratio [RR]: 0.83; 95% confidence interval [CI], 0.70-0.99, and RR: 0.85; 95% CI, 0.74-0.97, respectively). SIMS were associated with significantly shorter operative time (weighed mean difference [WMD]: 8.67 min; 95% CI, 17.32 to -0.02), lower day 1 pain scores (WMD: 1.74; 95% CI, -2.58 to -0.09), and less postoperative groin pain (RR: 0.18; 95% CI, 0.04-0.72). Repeat continence surgery (RR: 6.72; 95% CI, 2.39-18.89) and de novo urgency incontinence (RR: 2.08; 95% CI, 1.01-4.28) were significantly higher in the SIMS group. There was no significant difference in the QoL scores between the groups (WMD: 33.46; 95% CI, -20.62 to 87.55). No studies compared cost to health services. SIMS are associated with inferior patient-reported and objective cure rates on the short-term follow-up, as well as higher reoperation rates for SUI when compared with SMUS. Copyright © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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              Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up.

              Alexandre Resende, Paulo Dinis, João Francisco Botelho … (2011)
              Contemporary surgical treatment of female stress urinary incontinence (SUI) includes retropubic and transobturator (TO) midurethral slings (MUS). Case series of single-incision slings (SIS) have shown similar outcomes with lower morbidity. Our aim was to assess the cure rates, complications, and quality-of-life impact of one standard TO MUS and two SIS. Ninety consecutive patients with clinically and urodynamically proven SUI were enrolled in an exploratory randomised phase 2 trial. Patients with previous SUI surgery, major pelvic organ prolapse, mixed incontinence, or detrusor overactivity were excluded. Patients were treated randomly with TVT-O, TVT-Secur, or Mini-Arc. Postoperative visits were scheduled at 6 and 12 mo. The King's Health Questionnaire (KHQ) was repeated at 6 mo. Cure was defined as the absence of urine leakage, no pad use, and a negative cough test at 12 mo. Pain and other complications were also investigated. Cure rate was 83% after TVT-O, 67% after TVT-Secur, and 87% after Mini-Arc. Improvement was found in 10%, 13%, and 7% of the patients, respectively. Failures were 7% after TVT-O and Mini-Arc and 20% after TVT-Secur. TVT-O and Mini-Arc improved at least 15 points in >80% of the patients in six KHQ domains, whereas TVT-Secur could only achieve improvement in three of the nine domains. The pain score was lower in the Mini-Arc group. Complications were more numerous after TVT-O. This study has the limitations inherent in a phase 2 trial with a follow-up limited to 12 mo. Mini-Arc offers cure and improvement rates similar to TVT-O, whereas TVT-Secur may yield an inferior outcome. These findings recommend the urgent launch of large randomised phase 3 studies comparing conventional MUS with SIS, with Mini-Arc the advised option. Copyright © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Gynecol Minim Invasive Ther
                Journal ID (iso-abbrev): Gynecol Minim Invasive Ther
                Journal ID (publisher-id): GMIT
                Title: Gynecology and Minimally Invasive Therapy
                Publisher: Wolters Kluwer - Medknow (India )
                ISSN (Print): 2213-3070
                ISSN (Electronic): 2213-3089
                Publication date Collection: Jul-Sep 2019
                Publication date (Electronic): 29 August 2019
                Volume: 8
                Issue: 3
                Pages: 113-117
                Affiliations
                [1]Department of Gynecology, Bellvitge University Hospital, L'hospitalet De Llobregat, Barcelona, Spain
                Author notes
                Address for correspondence: Dr. Jordi Ponce-Sebastià and Dr. Miriam Campos-Delgado, Department of Gynecology, Bellvitge University Hospital, L'Hospitalet de Llobregat, C. Feixa Llarga s/n, Barcelona, Spain. E-mail: jponce@ 123456bellvitgehospital.cat , mcampos@ 123456bellvitgehospital.cat
                Article
                Publisher ID: GMIT-8-113
                DOI: 10.4103/GMIT.GMIT_104_18
                PMC ID: 6743235
                SO-VID: 1befd88a-24bd-4c93-a511-5a6e8bef1b39
                Copyright © Copyright: © 2019 Gynecology and Minimally Invasive Therapy
                License:

                This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

                History
                Date received : 29 October 2018
                Date revision received : 11 April 2019
                Date accepted : 25 April 2019
                Categories
                Subject: Original Article

                Keywords: ambulatory surgical procedures,local anesthesia,miniarc precise,patient satisfaction,stress urinary incontinence,suburethral slings
                Data availability:
                Keywords: ambulatory surgical procedures, local anesthesia, miniarc precise, patient satisfaction, stress urinary incontinence, suburethral slings

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