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Abdel-Fattah M, Cooper D, Davidson T, Kilonzo M, Boyers D, Bhal K, McDonald A, Wardle J, N'Dow J, MacLennan G, Norrie J. Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT. Health Technol Assess 2022; 26:1-190. [PMID: 36520097 PMCID: PMC9761550 DOI: 10.3310/btsa6148] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2022] Open
Abstract
BACKGROUND Stress urinary incontinence is the most common type of urinary incontinence in premenopausal women. Until recently, synthetic mid-urethral slings (mesh/tape) were the standard surgical treatment, if conservative management failed. Adjustable anchored single-incision mini-slings are newer, use less mesh and may reduce perioperative morbidity, but it is unclear how their success rates and safety compare with those of standard tension-free mid-urethral slings. OBJECTIVE The objective was to compare tension-free standard mid-urethral slings with adjustable anchored single-incision mini-slings among women with stress urinary incontinence requiring surgical intervention, in terms of patient-reported effectiveness, health-related quality of life, safety and cost-effectiveness. DESIGN This was a pragmatic non-inferiority randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). SETTING The trial was set in 21 UK hospitals. PARTICIPANTS Participants were women aged ≥ 18 years with predominant stress urinary incontinence, undergoing a mid-urethral sling procedure. INTERVENTIONS Single-incision mini-slings, compared with standard mid-urethral slings. MAIN OUTCOME MEASURES The primary outcome was patient-reported success rates on the Patient Global Impression of Improvement scale at 15 months post randomisation (≈ 1 year post surgery), with success defined as outcomes of 'very much improved' or 'much improved'. The primary economic outcome was incremental cost per quality-adjusted life-year gained. Secondary outcomes were adverse events, impact on other urinary symptoms, quality of life and sexual function. RESULTS A total of 600 participants were randomised. At 15 months post randomisation, adjustable anchored single-incision mini-slings were non-inferior to tension-free standard mid-urethral slings at the 10% margin for the primary outcome [single-incision mini-sling 79% (212/268) vs. standard mid-urethral sling 76% (189/250), risk difference 4.6, 95% confidence interval -2.7 to 11.8; p non-inferiority < 0.001]. Similarly, at 3 years' follow-up, patient-reported success rates in the single-incision mini-sling group were non-inferior to those of the standard mid-urethral sling group at the 10% margin [single-incision mini-sling 72% (177/246) vs. standard mid-urethral sling 67% (157/235), risk difference 5.7, 95% confidence interval -1.3 to 12.8; p non-inferiority < 0.001]. Tape/mesh exposure rates were higher for single-incision mini-sling participants, with 3.3% (9/276) [compared with 1.9% (5/261) in the standard mid-urethral sling group] reporting tape exposure over the 3 years of follow-up. The rate of groin/thigh pain was slightly higher in the single-incision mini-sling group at 15 months [single-incision mini-sling 15% (41/276) vs. standard mid-urethral sling 12% (31/261), risk difference 3.0%, 95% confidence interval -1.1% to 7.1%]; however, by 3 years, the rate of pain was slightly higher among the standard mid-urethral sling participants [single-incision mini-sling 14% (39/276) vs. standard mid-urethral sling 15% (39/261), risk difference -0.8, 95% confidence interval -4.1 to 2.5]. At the 3-year follow-up, quality of life and sexual function outcomes were similar in both groups: for the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life, the mean difference in scores was -1.1 (95% confidence interval -3.1 to 0.8; p = 0.24), and for the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological Association-Revised, it was 0 (95% confidence interval -0.1, 0.1; p = 0.92). However, more women in the single-incision mini-sling group reported dyspareunia [12% (17/145), compared with 4.8% (7/145) in the standard mid-urethral sling group, risk difference 7.0%, 95% confidence interval 1.9% to 12.1%]. The base-case economics results showed no difference in costs (-£6, 95% confidence interval -£228 to £208) or quality-adjusted life-years (0.005, 95% confidence interval -0.068 to 0.073) between the groups. There is a 56% probability that single-incision mini-slings will be considered cost-effective at the £20,000 willingness-to-pay threshold value for a quality-adjusted life-year. LIMITATIONS Follow-up data beyond 3 years post randomisation are not available to inform longer-term safety and cost-effectiveness. CONCLUSIONS Single-incision mini-slings were non-inferior to standard mid-urethral slings in patient-reported success rates at up to 3 years' follow-up. FUTURE WORK Success rates, adverse events, retreatment rates, symptoms, and quality-of-life scores at 10 years' follow-up will help inform long-term effectiveness. TRIAL REGISTRATION This trial was registered as ISRCTN93264234. FUNDING This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 47. See the NIHR Journals Library website for further project information.
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Affiliation(s)
- Mohamed Abdel-Fattah
- Aberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK
| | - David Cooper
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Tracey Davidson
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Mary Kilonzo
- Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | - Dwayne Boyers
- Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | - Kiron Bhal
- Obstetrics and Gynaecology, University Hospital of Wales, Cardiff, UK
| | - Alison McDonald
- Aberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK
| | | | - James N'Dow
- Academic Urology Unit, University of Aberdeen, Aberdeen, UK
| | - Graeme MacLennan
- Aberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK
| | - John Norrie
- Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK
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Yıldız G, Batur AF, Akand M, Kılıç Ö, Şahin MO. Comparison of Two Single-Incision Mini-Slings for the Treatment of Incontinence. Med Princ Pract 2020; 30:85-91. [PMID: 32911466 PMCID: PMC7923843 DOI: 10.1159/000511465] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2020] [Accepted: 09/05/2020] [Indexed: 11/19/2022] Open
Abstract
INTRODUCTION This study aimed to compare the safety and efficacy of 2 single-incision mini-sling (SIMS) systems with different designs of anchoring mechanism. METHODS The records of patients who have been operated for the treatment of female stress urinary incontinence (SUI) with 2 different SIMS systems were retrospectively evaluated. Patient characteristics, physical examination results, and quality of life (QoL) questionnaires were used to evaluate the patients. Primary efficacy endpoints were the cure and failure rates. Secondary efficacy endpoints were complications and differences in QoL questionnaires. RESULTS Eighty-three patients from group 1 (Ophira SIMS system) and 77 patients from group 2 (Gallini SIMS system) were evaluated. There was no significant difference between the 2 groups regarding patient characteristics. The objective cure rates were found to be 83.1 and 79.2% in group 1 and group 2, respectively (p = 0.09). Mesh-related complications, such as anchor displacement, bladder erosion, vaginal erosion, and groin pain, were more common in group 1. No severe complications were observed. For both groups, a significant improvement in all scores of QoL questionnaires was observed after surgery; however, the differences between 2 groups were not significant. CONCLUSIONS The present study showed that the treatment of female SUI with 2 different SIMS systems had similar efficacy, complication rates, and scores in QoL questionnaires.
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Affiliation(s)
- Guner Yıldız
- Urology Clinic, Health Sciences University Dr. Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Izmir, Turkey
| | - Ali Furkan Batur
- Department of Urology, Selçuk University, School of Medicine, Konya, Turkey,
| | - Murat Akand
- Department of Urology, Selçuk University, School of Medicine, Konya, Turkey
| | - Özcan Kılıç
- Department of Urology, Selçuk University, School of Medicine, Konya, Turkey
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Karakeçi A, Eftal TC, Keleş A, Gölbaşı C, Onur R. Single-incision midurethral sling shows less pain and similar success rate in a short-term follow-up compared to the transobturator tape method in the treatment of stress urinary incontinence. Turk J Urol 2019; 46:63-68. [PMID: 31658016 DOI: 10.5152/tud.2019.19105] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2019] [Accepted: 06/10/2019] [Indexed: 01/22/2023]
Abstract
OBJECTIVE To compare the efficacy, complications, quality of life, and patient satisfaction rates in women treated for stress urinary incontinence (SUI) using the adjustable anchored single-incision midurethral sling (SIMS) and standard midurethral sling (MUS) procedures. MATERIAL AND METHODS A total of 113 women between October 2012 and October 2016 underwent either the adjustable SIMS (n=54) or MUS (n=57) procedure. The postoperative pain profile was assessed using a 10-point visual analog scale at the fixed time-point quality of life and an additional postoperative 3rd week appointment. We asked our patients the following two questions to evaluate their satisfaction with surgery and their preference: "Would you have this kind of surgery again?" (Q1), and "Would you recommend this type of surgery to another patient with same symptoms?" (Q2). For the evaluation of patient complaints, the Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6) were used before and after the procedure. RESULTS Women in the SIMS group had a significantly lower postoperative pain profile for up to 3 weeks (p<0.001). There was no significant difference in perioperative complications and postoperative continence rates between the groups. With regard to Q1 and Q2, a significant difference was found between the groups (p=0.003 and p=0.002, respectively). While the questionnaire scores of the IIQ-7 and UDI-6 were also significantly improved at postoperative evaluations (p<0.001), there was no significant difference between the two groups. CONCLUSION SIMS is associated with a significantly improved postoperative pain profile and earlier return to work when compared to MUS.
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Affiliation(s)
- Ahmet Karakeçi
- Department of Urology, Fırat University School of Medicine, Elazığ, Turkey
| | - Taner Cüneyt Eftal
- Department of Obstetric and Gynecology, Tepecik Training and Research Hospital, İzmir, Turkey
| | - Ahmet Keleş
- Department of Urology, Esenyurt State Hospital, İstanbul, Turkey
| | - Ceren Gölbaşı
- Department of Obstetric and Gynecology, Tepecik Training and Research Hospital, İzmir, Turkey
| | - Rahmi Onur
- Department of Urology, Marmara University Pendik Training and Research Hospital, İstanbul, Turkey
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Alexandridis V, Rudnicki M, Jakobsson U, Teleman P. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial. Int Urogynecol J 2019; 30:1465-1473. [PMID: 31222572 PMCID: PMC6706362 DOI: 10.1007/s00192-019-04004-w] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/01/2019] [Accepted: 05/28/2019] [Indexed: 12/22/2022]
Abstract
Introduction and hypothesis The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. Methods This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. Results In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. Conclusions Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.
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Affiliation(s)
- Vasileios Alexandridis
- Department of Obstetrics and Gynecology, Skane University Hospital, Lund, Sweden. .,Faculty of Medicine, Lund University, Lund, Sweden. .,Department of Obstetrics and Gynecology, Skane University Hospital, Jan Waldenströms gata 47, 214 66, Malmö, Sweden.
| | - Martin Rudnicki
- Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.,Department of Clinical Research, University of Southern Denmark, Odense, Denmark
| | - Ulf Jakobsson
- Faculty of Medicine, Lund University, Lund, Sweden.,Center for Primary Healthcare Research, Clinical Research Center, Malmö, Sweden
| | - Pia Teleman
- Department of Obstetrics and Gynecology, Skane University Hospital, Lund, Sweden.,Faculty of Medicine, Lund University, Lund, Sweden
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Current Role of Urethrolysis and Partial Excision in Patients Seeking Revision of Anti-Incontinence Sling. Female Pelvic Med Reconstr Surg 2018; 25:409-414. [DOI: 10.1097/spv.0000000000000596] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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Song P, Wen Y, Huang C, Wang W, Yuan N, Lu Y, Wang Q, Zhang T, Wen J. The efficacy and safety comparison of surgical treatments for stress urinary incontinence: A network meta-analysis. Neurourol Urodyn 2018; 37:1199-1211. [PMID: 29331033 DOI: 10.1002/nau.23468] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2017] [Accepted: 11/14/2017] [Indexed: 02/05/2023]
Abstract
AIMS Stress urinary incontinence (SUI) is a common problem worldwide. Mainstream surgical procedures include tension-free vaginal tape (TVT), transobturator tape (TOT), tension-free vaginal tape-obturator (TVT-O), tension-free vaginal tape SECUR (TVT-S), and adjustable single-incision sling (Ajust). The aim of this study was to compare the efficacy and safety of these surgical procedures and assess which surgery is most optimal for SUI by adopting a network meta-analysis (NMA). METHODS Electronic databases including PubMed, Cochrance Library, and Embase database were researched systematically, until March 21, 2017. The randomized controlled trials (RCTs) that compared the efficacy and safety of TVT, TOT, TVT-O, TVT-S, and Ajust were identified. The studies were included in the analysis when met the predefined inclusion criteria. After demographic and outcome data extraction, a network meta-analysis was conducted with software R 3.3.2 and STATA 14.0. Objective cure rate, subjective cure rate, postoperative complication rate, bladder perforation, tape erosion, urinary retention, and postoperative pain were considered as outcomes, and the outcomes were displayed as odds ratios (ORs) and 95% credible intervals (CrI). The consistency of direct and indirect evidence was assessed by node splitting. The ranks based on probabilities of intervention for the different endpoints were performed. RESULTS Fourty-five RCTs with 7295 participants were analyzed. The NMA results revealed that, TVT, TOT, and Ajust had a higher objective cure rate than TVT-O and TVT-S (TVT-O: OR = 0.76, 95%CI [0.61, 0.94]; TVT-S: OR = 0.41, 95%CI [0.28, 0.60]). TVT, TOT, and TVT-O had a superior subjective cure rate than TVT-S and Ajust (Ajust: OR = 0.45, 95%CI [0.20, 0.91]; TVT-S: OR = 0.29, 95%CI [0.15, 0.56]). With TVT as the reference, TVT-S had a statistically lower postoperative complication rate (TVT-S: OR = 0.39, 95%CI [0.16, 0.89]). TVT-O, TVT-S, and TOT had a significantly lower bladder perforation rate (TOT: OR = 0.076, 95%CI [0.0060, 0.37]; TVT-O: OR = 4.1e-17, 95%CI [6.1e-48, 0.0032]; TVT-S: OR = 3.8e-17, 95%CI [1.8e-48, 0.0052]). There were no obvious differences between the five treatments for tape erosion. TVT-O exhibited a less postoperative retention (TVT-O: OR = 0.35, 95%CI [0.16, 0.74]). Probabilities of ranking results indicated that TOT was the treatment with best ranking in efficacy and a relatively high safety. CONCLUSIONS Our study recommend TOT as the optimal regimen for SUI with high efficacy and moderate safety when compared with TVT, TVT-O, TVT-S, and Ajust interventions. However, with the limitation of our study, additional high-quality studies are needed to further evaluate the outcomes.
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Affiliation(s)
- Pan Song
- Department of Urodynamic Centre and Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Yibo Wen
- Department of Urodynamic Centre and Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Chuiguo Huang
- Department of Urology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Wancong Wang
- Department of Digestion, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Naijun Yuan
- The College of Traditional Chinese Medicine of Jinan University, Institute of Integrated Traditional Chinese and Western Medicine of Jinan University, Guangzhou, Guangdong Province, China
| | - Yinliang Lu
- Department of Radiotherapy, China-Japan Union Hospital of Jilin University, Changchun, Jilin Province, China
| | - Qingwei Wang
- Department of Urodynamic Centre and Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Tao Zhang
- Department of Urodynamic Centre and Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Jianguo Wen
- Department of Urodynamic Centre and Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
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Rudnicki M, von Bothmer-Ostling K, Holstad A, Magnusson C, Majida M, Merkel C, Prien J, Jakobsson U, Teleman P. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial. Acta Obstet Gynecol Scand 2017; 96:1347-1356. [DOI: 10.1111/aogs.13205] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2016] [Accepted: 07/28/2017] [Indexed: 12/13/2022]
Affiliation(s)
- Martin Rudnicki
- Department of Obstetrics and Gynecology; Odense University Hospital; Odense Denmark
| | | | - Anja Holstad
- Department of Obstetrics and Gynecology; Gjøvik Hospital; Gjøvik Norway
| | - Claes Magnusson
- Department of Obstetrics and Gynecology; Sahlgrenska University Hospital; Gothenburg Sweden
| | - Memona Majida
- Department of Obstetrics and Gynecology; Ahus University Hospital; Oslo Norway
| | - Constanze Merkel
- Department of Obstetrics and Gynecology; Regional Hospital of Northern Jutland; Frederikshavn Denmark
| | - Jens Prien
- Department of Obstetrics and Gynecology; Zealand Hospital; Nykøbing Falster Denmark
| | - Ulf Jakobsson
- Center for Primary Healthcare Research; Faculty of Medicine; University of Lund; Lund Sweden
| | - Pia Teleman
- Department of Obstetrics and Gynecology; Skåne University Hospital; Lund University; Lund Sweden
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Shamout S, Campeau L. Stress urinary incontinence in women: Current and emerging therapeutic options. Can Urol Assoc J 2017; 11:S155-S158. [PMID: 28616118 DOI: 10.5489/cuaj.4613] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/14/2023]
Abstract
Surgical management of stress urinary incontinence (SUI) is most commonly achieved by midurethral synthetic sling (MUS) insertion as a first-line surgical option. A great deal of research continues to evolve new management strategies to reach an optimal balance of high efficacy and minimal adverse events. This expert opinion review provides a brief and comprehensive discussion of recent advances and ongoing research in the management of SUI, with an emphasis on single-incision mini-slings, vaginal laser treatment, and cell-based therapy. It is based on data obtained from numerous published meta-analyses and original studies identified through literature search. Single-incision mini-slings appear equally effective initially compared with standard MUS (retropubic or transobturator) for the treatment of female SUI; however, this efficacy lacks durability evidence beyond one-year followup. There is a lack of sufficient clinical evidence to currently confirm long-term safety and effectiveness of cell-therapy and non-ablative vaginal laser therapy, besides suggestion of apparent initial safety. There are still significant challenges to overcome before widespread clinical practice of the latter two modalities. Future research should be aimed at identifying groups of patients who might benefit from these minimally invasive therapeutic options.
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Affiliation(s)
- Samer Shamout
- Division of Urology, Department of Surgery, McGill University, Montreal, QC, Canada
| | - Lysanne Campeau
- Division of Urology, Department of Surgery, McGill University, Montreal, QC, Canada
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Anding R, Schoen M, Kirschner-Hermanns R, Fisang C, Müller SC, Latz S. Minimally invasive treatment of female stress urinary incontinence with the adjustable single-incision sling system (AJUST ™) in an elderly and overweight population. Int Braz J Urol 2017; 43:280-288. [PMID: 28128907 PMCID: PMC5433368 DOI: 10.1590/s1677-5538.ibju.2015.0751] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/29/2015] [Accepted: 10/15/2016] [Indexed: 11/22/2022] Open
Abstract
Introduction The prevalence of urinary incontinence is increasing. Two major risk factors are overweight and age. We present objective and subjective cure rates of elderly and overweight patients treated with an adjustable single-incision sling system (AJUST™, C.R. BARD, Inc.). Materials and Methods Between 04/2009 and 02/2012 we treated 100 female patients with the single incision sling. Patients were retrospectively evaluated by Stamey degree of incontinence, cough test, pad use, and overall satisfaction. The primary outcomes of the study were objective and subjective cure rates, secondary outcomes were the safety profile of the sling and complications. Results The overall success rate in this population was 84.6% with a mean follow-up of 9.3 months. The average usage of pads per day decreased from 4.9 to 1.6 and was significantly lower in patients with a BMI <30 (p=0.004). Postoperative residual SUI was also lower in patients with a BMI <30 (p=0.006). Postoperative satisfaction was better in patients with a lower BMI, but this difference did not reach a level of significance (p=0.055). There were no complications such as bleeding, bladder injury, or tape infection. Conclusions In elderly and obese patients a considerable success rate is achievable with this quick and minimal invasive procedure. However, the success rate shows a clear trend in favor of a lower body-mass-index. The cut-off point has been identified at a BMI of 30. The AJUST™ system can be regarded as safe and beneficial for elderly and obese patients.
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Affiliation(s)
- Ralf Anding
- Department of Urology and Neuro-Urology, University Hospital Bonn, Germany
| | - Manuel Schoen
- Department of Urology, Klinikum Ibbenbueren GmbH, Germany
| | | | - Christian Fisang
- Department of Urology and Neuro-Urology, University Hospital Bonn, Germany
| | - Stefan C Müller
- Department of Urology and Neuro-Urology, University Hospital Bonn, Germany
| | - Stefan Latz
- Department of Urology and Neuro-Urology, University Hospital Bonn, Germany
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Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling. Int Urogynecol J 2016; 28:1041-1047. [DOI: 10.1007/s00192-016-3221-3] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2016] [Accepted: 11/21/2016] [Indexed: 11/25/2022]
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Tutolo M, De Ridder D, Van der Aa F. Single incision slings: Are they ready for real life? World J Obstet Gynecol 2016; 5:197-209. [DOI: 10.5317/wjog.v5.i2.197] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2015] [Revised: 11/23/2015] [Accepted: 01/22/2016] [Indexed: 02/05/2023] Open
Abstract
AIM: To review of the efficacy and safety outcomes of different single incision slings (SIS) systems, also in comparison with traditional slings.
METHODS: A literature search was conducted in PubMed/MEDLINE database. The research was restricted to randomized and/or prospective trials and retrospective studies, published after 2006, with at least 20 patients with non-neurogenic stress urinary incontinence (SUI). The studies had to assess efficacy and/or safety of the SIS with a minimum follow-up of 12 mo. All the paper assessing the performance of tension free vaginal tape secur were excluded from this review. The final selection included 19 papers fulfilling the aforementioned criteria. Two authors independently reviewed the selected papers.
RESULTS: Four different SIS systems were analysed: Ajust®, Ophira®, Altis® and MiniArc®. The average objective cure rate was 88%. Overall no statistically significant differences were found between SIS and traditional mid-urethral slings (MUS) in terms of objective cure (all P > 0.005). Only one paper showed a statistically lower success rate in MiniArc®vs Advantage® slings (40% vs 90%) and higher rates of failure in the SIS group. Since there was a great variability in terms of tests performed, it was not possible to compare subjective cure between studies. The vast part of the studies showed no major complications after SIS surgery. We also observed very low reported pain rates in SIS patients. The RCTs on Ajust® and MiniArc®, showed better outcomes in terms of post-operative pain compared to MUS. None of the patients reported long- term pain complains.
CONCLUSION: SIS showed similar efficacy to that of traditional slings but lower short-term pain, complication and failure rates.
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Evaluation and surgery for stress urinary incontinence: A FIGO working group report. Neurourol Urodyn 2016; 36:518-528. [DOI: 10.1002/nau.22960] [Citation(s) in RCA: 31] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/05/2015] [Accepted: 12/20/2015] [Indexed: 02/04/2023]
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Xin X, Song Y, Xia Z. A comparison between adjustable single-incision sling and tension-free vaginal tape-obturator in treating stress urinary incontinence. Arch Gynecol Obstet 2015; 293:457-63. [PMID: 26573010 DOI: 10.1007/s00404-015-3949-x] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/02/2015] [Accepted: 10/28/2015] [Indexed: 11/27/2022]
Abstract
PURPOSE To compare the subjective and objective cure rates, postoperative pain, postoperative complications, and postoperative quality of life of adjustable single-incision sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-O™) in the treatment of female stress urinary incontinence (SUI). METHODS Female patients with SUI (N = 368) were randomized to receive either Ajust® (N = 184) or TVT-O™ procedure (N = 184) between January 2012 and October 2013. Efficacy was evaluated using cure rate, postoperative complications, postoperative pain profile (using Visual Analogue Scale), Patient Global Impression of Improvement Scale, and International Consultation on Incontinence Questionnaire-Short Form. RESULTS The patients from Ajust® and TVT-O™ groups had no statistically significant difference in subjective and objective cure rates (94.4 vs 90.7 %, P = 0.171; 97.2 vs 90.7 %, P = 0.195). Compared with the TVT-O™ group, patients in the Ajust® group had significantly less postoperative pain, shorter operative duration, and less intraoperative blood loss (all P values < 0.05). No significant difference in perioperative complications was observed between these two groups. Patients in Ajust® group had shorter recovery time (P < 0.001) compared to TVT-O™ group. The postoperative quality of life of patients in these two groups was significantly improved compared to baseline; however, no significant difference was observed in the average improvement of life between these two groups (P = 0.115). CONCLUSIONS Ajust® procedure is simple, safe, and effective for the treatment of SUI. Compared with TVT-O™, patients receiving Ajust® had less intraoperative blood loss, less postoperative pain, and shorter recovery time.
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Affiliation(s)
- Xing Xin
- Shengjing Hospital of China Medical University, Shenyang, 110004, China.
| | - Yue Song
- Shengjing Hospital of China Medical University, Shenyang, 110004, China.
| | - Zhijun Xia
- Shengjing Hospital of China Medical University, Shenyang, 110004, China.
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Postoperative pain after adjustable single-incision or transobturator sling for incontinence: a randomized controlled trial. Obstet Gynecol 2015; 125:27-34. [PMID: 25560100 DOI: 10.1097/aog.0000000000000604] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/11/2023]
Abstract
OBJECTIVE To compare postoperative pain scores and assess efficacy between an adjustable single-incision sling and a standard transobturator sling for stress urinary incontinence (SUI). METHODS This single-blinded randomized controlled trial involved 156 women with clinically proven SUI. Women were allocated to receive either an adjustable single-incision or a transobturator sling. The primary outcome was postoperative pain score on a visual analog scale. Secondary outcomes were objective and subjective cure rates at 12 months, symptom bother scores, quality of life, and complications. RESULTS The mean pain score in the first week postoperatively was significantly lower at all time points in the adjustable single-incision sling group compared with the transobturator sling group. Maximum difference in pain score was reported on the evening of the day of surgery; median pain score was 1.0 (interquartile range 2.0) in the adjustable sling group and 3.0 (interquartile range 4.5) in the transobturator sling group (Mann Whitney U test P<.001). There was no statistical difference in analgesic use. The objective cure rates in the adjustable single-incision sling and in the transobturator sling group were 90.8% and 88.6% (P=.760), and the subjective cure rates were 77.2% and 72.9% (P=.577), respectively. No difference in the complication rate was found. CONCLUSION An adjustable single-incision sling for the treatment of SUI is associated with lower early postoperative pain scores but shows comparable cure rates with a transobturator at 12 months of follow-up. CLINICAL TRIAL REGISTRATION Netherlands Trial Register, http://www.trialregister.nl, NTR: 2558. LEVEL OF EVIDENCE I.
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Short-term outcomes of adjustable single-incision sling (Ajust™) procedure for stress urinary incontinence: a prospective single-center study. Eur J Obstet Gynecol Reprod Biol 2015; 186:59-62. [PMID: 25645605 DOI: 10.1016/j.ejogrb.2015.01.002] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/16/2014] [Revised: 12/29/2014] [Accepted: 01/12/2015] [Indexed: 01/15/2023]
Abstract
OBJECTIVES Slings have become the most widely performed surgical procedure for stress urinary incontinence (SUI) in last two decades. As the third generation sling, the efficacy of the early single-incision mini-sling was controversial. The aim of this study was to determine whether the new adjustable single-incision sling (Ajust™) is safe and effective in management of female SUI at 6-18 months follow-up. STUDY DESIGN 69 patients with SUI according the inclusion and exclusion criteria were considered adjustable single-incision sling (Ajust™) from September 2012 to September 2013. 67 patients finished 6-18 months follow-up. The data about clinical parameter, operation, complication, Urogenital Distress Inventory-Short Form (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7) and International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) in Chinese were collected in preoperative, 6-month and 12-month follow-up. RESULTS All patients underwent successful adjustable single-incision sling (Ajust(TM)) placement. The subjective cure rate and objective cure rate was 82.0%, 92.5% in 6-month follow-up and 82.3%, 91.2% in 12-month follow-up respectively. There were no significant perioperative complications such as bladder perforation, major bleeding requiring blood transfusion in the present study. Sling exposure was observed in two patients (3.2%). CONCLUSIONS Adjustable single-incision sling (Ajust(TM)) was a safe and effective option for treating female SUI and was associated with comparable subjective and objective success rates when compared to standard midurethral slings (TVT-O) at a 6-18 months follow-up.
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Hamann MF, Naumann CM, Knüpfer S, Jünemann KP, Bauer R. [Urogynecology II: urinary incontinence in men and women: surgical treatment of urinary incontinence and prolapse]. Urologe A 2014; 53:1671-80; quiz 1681-2. [PMID: 25316184 DOI: 10.1007/s00120-014-3607-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/24/2022]
Abstract
Numerous surgical procedures are available for the treatment of stress urinary incontinence in women and men. On a par with classical therapy options (e.g. colposuspension and artificial sphincter prosthesis) suburethral tape procedures have become established as the minimally invasive standard of care. Regarding comorbidities and recurrent urinary incontinence, therapeutic procedures should be modified on an individual basis. It is crucial to involve patients in therapeutic decision-making and counseling should be given with respect to all conservative and operative alternatives.
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Affiliation(s)
- M F Hamann
- Klinik für Urologie und Kinderurologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Arnold Heller Str. 7, 24105, Kiel, Deutschland,
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Natale F, Dati S, La Penna C, Rombolà P, Cappello S, Piccione E. Single incision sling (Ajust™) for the treatment of female stress urinary incontinence: 2-year follow-up. Eur J Obstet Gynecol Reprod Biol 2014; 182:48-52. [PMID: 25233444 DOI: 10.1016/j.ejogrb.2014.08.011] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/16/2014] [Revised: 06/13/2014] [Accepted: 08/07/2014] [Indexed: 02/09/2023]
Abstract
OBJECTIVE The primary outcome of this study was to evaluate the subjective and objective outcomes of an adjustable Single Incision Sling (Ajust™ C.R. Bard Inc., New Providence, NJ, USA) for the treatment of SUI, with a 2-year follow-up. The secondary outcome was to evaluate the safety of this procedure and the impact of this mini-sling on the filling and voiding phases of the bladder. STUDY DESIGN In our prospective multicenter study we included 95 females with a clinical symptomatic and urodynamic diagnosis of primary SUI, and unsuccessful previous conservative treatment. Cure rate was evaluated objectively, using a standardized cough stress test and subjectively using the patient global impression of improvement. The King's Health questionnaire was used to evaluate quality of life (QoL). Urgency was evaluated using the patient perception of intensity of urgency scale. Complications were assessed intra-, peri- and post-operatively. All patients underwent urodynamic studies pre-operatively and at 6 months. The McNemar chi-square test was used to compare categorical variables, the paired t-test for continuous parametric variables, and the Fisher exact test for continuous non-parametric variables. A logistic regression model and odds ratios (with 95 percent confidence intervals) were used to assess the independent prognostic value of four variables for the outcome (age, parity, body mass index and menopausal status). RESULTS 92 Patients completed the 2-year follow-up. The objective cure rate was 83.7% and the subjective cure rate was 81.5%. De novo urgency was present in 9 patients (9.8%) and was associated with de novo urge incontinence in 6 patients (6.5%). Only 1 patient with de novo urge incontinence showed de novo detrusor overactivity. Regarding QoL, the King's Health Questionnaire indicated a statistically significant improvement in all domains except sleep. We observed no intraoperative complications. Post-operatively 1 patient referred pain in the right leg, 3 patients had mesh extrusions, 1 patient had recurrent urinary tract infections. Post-operative urodynamics showed a statistically significant increase of detrusor pressure at maximum flow and a reduction of maximum flow rate. No patients were obstructed according to the Blaivas and Groutz nomogram.
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Affiliation(s)
- Franca Natale
- Department of Urogynecology-S. Carlo-IDI Hospital, Rome, Italy.
| | - Stefano Dati
- Unit of Urogynecology, "Casilino" General Hospital, Rome, Italy
| | - Chiara La Penna
- Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy
| | - Pasquale Rombolà
- Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy
| | - Stefania Cappello
- Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy
| | - Emilio Piccione
- Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy
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Debodinance P. [AJUST: prospective study about 60 patients]. Prog Urol 2014; 24:154-5. [PMID: 24560201 DOI: 10.1016/j.purol.2013.11.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/31/2013] [Accepted: 11/05/2013] [Indexed: 11/16/2022]
Affiliation(s)
- P Debodinance
- Service de gynécologie-obstétrique, centre hospitalier de Dunkerque, avenue de la Polyclinique, 59760 Grande Synthe, France.
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Boyers D, Kilonzo M, Mostafa A, Abdel-Fattah M. Comparison of an adjustable anchored single-incision mini-sling, Ajust®, with a standard mid-urethral sling, TVT-OTM: a health economic evaluation. BJU Int 2013; 112:1169-77. [DOI: 10.1111/bju.12388] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
Affiliation(s)
- Dwayne Boyers
- Health Economics Research Unit; University of Aberdeen; Aberdeen UK
- Health Services Research Unit; University of Aberdeen; Aberdeen UK
| | - Mary Kilonzo
- Health Economics Research Unit; University of Aberdeen; Aberdeen UK
| | - Alyaa Mostafa
- Division of Applied Health Sciences; University of Aberdeen; Aberdeen UK
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MARTAN A, KRHUT J, MAŠATA J, ŠVABÍK K, HALAŠKA M, HORČIČKA L, ZACHOVAL R. Prospective Randomized Study of MiniArc and Ajust Single Incision Sling Procedures. Low Urin Tract Symptoms 2013; 6:172-4. [DOI: 10.1111/luts.12041] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/11/2013] [Revised: 08/28/2013] [Accepted: 09/11/2013] [Indexed: 12/13/2022]
Affiliation(s)
- Alois MARTAN
- Department of Obstetrics and Gynecology; Charles University and General Faculty Hospital in Prague; Prague Czech Republic
| | - Jan KRHUT
- Department of Urology; Ostrava University; Ostrava Czech Republic
| | - Jaromír MAŠATA
- Department of Obstetrics and Gynecology; Charles University and General Faculty Hospital in Prague; Prague Czech Republic
| | - Kamil ŠVABÍK
- Department of Obstetrics and Gynecology; Charles University and General Faculty Hospital in Prague; Prague Czech Republic
| | - Michael HALAŠKA
- Department of Obstetrics and Gynecology; Charles University and Faculty Hospital, Bulovka; Prague Czech Republic
| | - Lukáš HORČIČKA
- GONA - Outpatient Clinic of Obstetrics and Gynecology; Prague Czech Republic
| | - Roman ZACHOVAL
- Department of Urology; Thomayer Hospital; Prague Czech Republic
- Department of Urology; 1st Faculty of Medicine, Charles University and General Faculty Hospital; Prague Czech Republic
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Tantanasis T, Daniilidis A, Pantelis A, Chatzis P, Vrachnis N. Minimally invasive techniques for female stress urinary incontinence, how, why, when. Arch Gynecol Obstet 2013; 288:995-1001. [PMID: 24052223 DOI: 10.1007/s00404-013-3024-4] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2013] [Accepted: 09/03/2013] [Indexed: 11/30/2022]
Abstract
AIM The main purpose of this paper is to summarize the recent experience that has been obtained till now in the surgical treatment of urinary stress incontinence with less invasive techniques. MATERIALS AND METHODS We used current literature and papers published in MEDLINE and Cochrane library. The keywords used for this review were Stress urinary incontinence, Tension-free vaginal tape (TVT), Transobturator tape (TOT, TVT-O), and Single-incision mini-slings (SIMS). RESULTS Tension-free vaginal tape and the transobturator urethral suspension are the most commonly used surgical approach for women who suffer from stress urinary incontinence, with long-term success rates ranging from 84 to 95 %. TVT is shown to be as effective as the older colposuspension, associated with less post-operative complications, shorter hospital stay and shorter recovery period. Bladder perforations that have been mentioned with the TVT inserter apparently do not result in any clinically significant morbidity. Major vascular and bowel injuries have been reported at rates of 0.07 and 0.04 %, respectively. Studies between TVT-O and TOT show equal effectiveness with slightly lower cure rates than TVT group, but TOT had a significant lower risk of bladder and vaginal perforations. There were no significant differences in objective cure rates between 'inside-out' and 'outside-in' transobturator tapes. Very recently a meta-analysis does not support routine use of SIMS in clinical practice, moreover suggested the retropubic TVT as the preferred choice for the management of stress urinary incontinence due to familiarity, its effectiveness, minimal invasiveness and low complication and morbidity rates as a primary procedure. Similar results have been announced in a randomized control trial in USA. CONCLUSIONS Certainly, larger randomized clinical trials with longer follow-up about the mentioned techniques are needed to accurately determine the efficacy and safety of the mentioned minimally invasive techniques.
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Affiliation(s)
- Theocharis Tantanasis
- 2nd University Department of Obstetrics of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Hippokratio General Hospital, Thessaloniki, Greece
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Lizée D, Cornu JN, Peyrat L, Ciofu C, Beley S, Haab F. Mini-bandelettes pour le traitement de l’incontinence urinaire d’effort féminine : revue de la littérature. Prog Urol 2013; 23:917-25. [DOI: 10.1016/j.purol.2013.07.008] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2013] [Revised: 07/01/2013] [Accepted: 07/03/2013] [Indexed: 01/01/2023]
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Mostafa A, Lim CP, Hopper L, Madhuvrata P, Abdel-Fattah M. Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: an updated systematic review and meta-analysis of effectiveness and complications. Eur Urol 2013; 65:402-27. [PMID: 24055431 DOI: 10.1016/j.eururo.2013.08.032] [Citation(s) in RCA: 115] [Impact Index Per Article: 9.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/10/2013] [Accepted: 08/13/2013] [Indexed: 12/11/2022]
Abstract
CONTEXT An updated systematic review and meta-analysis of randomised controlled trials (RCTs) comparing single-incision mini-slings (SIMS) versus standard midurethral slings (SMUS) in the surgical management of female stress urinary incontinence (SUI). OBJECTIVE To evaluate the clinical efficacy, safety, and cost effectiveness of SIMS compared with SMUS in the treatment of female SUI. EVIDENCE ACQUISITION A literature search was performed for all RCTs and quasi-RCTs comparing SIMS with either transobturator tension-free vaginal tape (TO-TVT) or retropubic tension-free vaginal tape (RP-TVT). The literature search had no language restrictions and was last updated on May 2, 2013. The primary outcomes were patient-reported and objective cure rates at 12 to 36 mo follow-up. Secondary outcomes included operative data; peri- and postoperative complications, and repeat continence surgery. Data were analysed using RevMan software. Meta-analyses of TVT-Secur versus SMUS are presented separately as the former was recently withdrawn from clinical practice. EVIDENCE SYNTHESIS A total of 26 RCTs (n=3308 women) were included. After excluding RCTs evaluating TVT-Secur, there was no evidence of significant differences between SIMS and SMUS in patient-reported cure rates (risk ratio [RR]: 0.94; 95% confidence interval [CI], 0.88-1.00) and objective cure rates (RR: 0.98; 95% CI, 0.94-1.01) at a mean follow-up of 18.6 mo. These results pertained on comparing SIMS versus TO-TVT and RP-TVT separately. SIMS had significantly lower postoperative pain scores (weighted means difference [WMD]: -2.94; 95% CI, -4.16 to -1.73) and earlier return to normal activities and to work (WMD: -5.08; 95% CI, -9.59 to -0.56 and WMD: -7.20; 95% CI, -12.43 to -1.98, respectively). SIMS had a nonsignificant trend towards higher rates of repeat continence surgery (RR: 2.00; 95% CI, 0.93-4.31). CONCLUSIONS This meta-analysis shows that, excluding TVT-Secur, there was no evidence of significant differences in patient-reported and objective cure between currently used SIMS and SMUS at midterm follow-up while associated with more favourable recovery time. Results should be interpreted with caution due to the heterogeneity of the trials included.
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Castellier C, Doucède G, Debodinance P. [Place of the mini-sling in the treatment of female stress urinary incontinence]. ACTA ACUST UNITED AC 2013; 42:639-46. [PMID: 23973118 DOI: 10.1016/j.jgyn.2013.07.002] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/18/2013] [Revised: 06/20/2013] [Accepted: 07/01/2013] [Indexed: 11/15/2022]
Abstract
OBJECTIVE Evaluate the place of sub-urethral mini-slings in the treatment of female stress urinary incontinence. MATERIAL AND METHODS Review of the literature on 43 publications (comparative and prospective studies) more than 6443 patients who underwent for the treatment of urinary incontinence, a mini-strip type TVT®, TVT-S®, MiniArc®, Ajust®, Needleless®, Solyx®, or Ophira® in comparison to the conventional urethral sling. The comparison used objective (cough stress test and pad weight test) and subjective criteria (quality of life questionnaire). The papers have also studied the complication associated with these new techniques. RESULTS The overall effectiveness of this surgery varied between 40 to 84% for TVT-S®, 69 to 92% for MiniArc®, 80 to 91% for Ajust®, 87% for Needleless®, 95% for Solyx® and 85% for Ophira®. The efficacy on incontinence was higher with the TVT® TVT-S® and the MiniArc® (P=0.01 to 0.05). TVT-O® efficacy was higher than TVT-S® (P<0.01 and P=0.02). Conventional slings seems to be more efficient than TVT-S® and MiniArc® mini-slings. Ajust® mini-sling seems to be as efficient as MiniArc® and TVT-S® mini-sling and TVT-O®. It showed a decrease in the intensity of postoperative pain (P<0.001), faster return to normal activities (P=0.025) and use of a common local anesthetic to the adjustable mini-sling. CONCLUSION It seems that the adjustable mini-sling is currently the best compromise in terms of effectiveness and complications if the choice had to be among the mini-sling in the treatment of stress urinary incontinence.
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Affiliation(s)
- C Castellier
- Département de gynécologie-obstétrique, centre hospitalier Dunkerque, GCS Flandre-Maritime, avenue de la Polyclinique, 59760 Grande-Synthe, France
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Grigoriadis C, Bakas P, Derpapas A, Creatsa M, Liapis A. Tension-free vaginal tape obturator versus Ajust adjustable single incision sling procedure in women with urodynamic stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol 2013; 170:563-6. [PMID: 23972452 DOI: 10.1016/j.ejogrb.2013.07.041] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2012] [Revised: 06/17/2013] [Accepted: 07/29/2013] [Indexed: 12/27/2022]
Abstract
OBJECTIVE To assess the efficacy and complications of inside-out transobturator tension-free vaginal tape (TVT-O) in comparison with a single incision sling procedure (Ajust) for the treatment of urodynamic stress urinary incontinence. STUDY DESIGN Prospective closely matched controlled study. In total, 171 patients were included in the study: 86 women underwent the TVT-O procedure, while in other 85 cases the Ajust procedure was performed. Subjective and objective cure, improvement and failure rates, mean operative time, hospital stay and incidence of complications were assessed. RESULTS There was no statistically significant difference between the two groups for age, body mass index, parity, menopausal status and severity of prolapse. No major intraoperative complications occurred. There was no significant difference in the mean operative time and the duration of hospital stay between the two groups. The mean follow-up time of the study was 22.3 months (range 12-36 months). For the TVT-O group the objective cure rate was 86%, the improvement rate was 5.9% and the failure rate was 8.1%, while the subjective cure rate was 82.6%. For the Ajust group the objective cure rate was 84.7%, the improvement rate was 4.7%, 10.6% of patients showed no change in their symptoms and the subjective cure rate was 81.2%. CONCLUSIONS The Ajust sling procedure presents success rates, at 22 months' mean follow up, comparable to the TVT-O method. Both techniques seem to be safe and effective for the treatment of urodynamic stress urinary incontinence.
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Affiliation(s)
- C Grigoriadis
- 2nd Department of Obstetrics and Gynecology, University of Athens, Aretaieion Hospital, Greece.
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Sivaslioglu AA. Is there any place for a transobturator approach for minisling surgery? Int Urogynecol J 2013; 24:1589. [PMID: 23778999 DOI: 10.1007/s00192-013-2152-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2013] [Accepted: 06/04/2013] [Indexed: 11/29/2022]
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Basu M, Duckett J. Three-year results from a randomised trial of a retropubic mid-urethral sling versus the Miniarc single incision sling for stress urinary incontinence. Int Urogynecol J 2013; 24:2059-64. [PMID: 23712578 DOI: 10.1007/s00192-013-2125-8] [Citation(s) in RCA: 33] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2013] [Accepted: 04/28/2013] [Indexed: 01/01/2023]
Abstract
INTRODUCTION AND HYPOTHESIS There are limited long-term efficacy data on single-incision slings. The primary aim of this study was to evaluate the success rate of a single-incision sling versus a retropubic mid-urethral sling for cure of SUI at 3 years' follow-up, in order to assess whether there is a deterioration in efficacy over time. The secondary aims were to assess re-operation rates for each procedure and to evaluate any differences in disease-specific quality of life. METHODS This study was a 3-year questionnaire-based follow-up of a randomised controlled trial of the Miniarc single-incision sling versus the Advantage retropubic mid-urethral sling. Patients were considered failures if they documented stress incontinence on the symptom domain of the King's Health questionnaire (KHQ) or had undergone repeat surgery for stress incontinence. RESULTS Follow-up was available from 35 out of 38 women in the single-incision sling group (92.1 %) and from 26 out of 33 in the retropubic mid-urethral sling group (79.0 %). The overall 3-year failure rate was 20 out of 38 (52.6 %) in the single-incision sling group and 3 out of 33 (9.0 %) in the retropubic mid-urethral sling group (odds ratio 10.0, 95 % confidence interval 2.6-38.4). In the single-incision sling group, the failure rate increased from 40.5 % at 6 months to 52.6 % at 3 years with corresponding figures of 3 to 9 % in the retropubic mid-urethral sling group. CONCLUSIONS In this study, there was a significantly higher 3-year failure rate for the single-incision sling versus the retropubic mid-urethral sling. Both procedures had reduced efficacy over time.
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Affiliation(s)
- Maya Basu
- Department of Urogynaecology and Pelvic Reconstructive Surgery, St. George's Hospital, Blackshaw Road, London, SW17 0QT, UK,
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Naumann G, Steetskamp J, Meyer M, Laterza R, Skala C, Albrich S, Koelbl H. Sexual function and quality of life following retropubic TVT and single-incision sling in women with stress urinary incontinence: results of a prospective study. Arch Gynecol Obstet 2012; 287:959-66. [PMID: 23242512 PMCID: PMC3625405 DOI: 10.1007/s00404-012-2669-8] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2012] [Accepted: 11/28/2012] [Indexed: 11/27/2022]
Abstract
PURPOSE The objective of this prospective cohort study was to compare effectiveness, morbidity, quality of life (QoL) and sexual function in women treated with tension-free vaginal tape (TVT) versus single-incision sling (SIS) in the treatment of female stress urinary incontinence (SUI). METHODS Retropubic TVT sling or SIS was implanted in local anesthesia and patients were followed post-operatively for 6 months. Evaluation was performed to assess post-operative rate of continence, complications, changes in sexual function and patient reported quality of life. Female sexual function was evaluated before and after sling procedure using Female Sexual Function Index (FSFI) in sexually active patients. RESULTS From January 2009 to December 2011, 150 patients were enrolled and underwent a procedure to implant the retropubic TVT (n = 75) or the MiniArc(®) and Ajust(®) SIS (n = 75). Overall, 93.3 % of the patients who successfully received SIS demonstrated total restoration (84 %) or improvement of continence (9.3 %) at the 6 month post-operative study visit. In TVT group we found 88 % total continence and 6.7 % improvement, respectively. Improvements were seen in the QoL scores related to global bladder feeling (89.3 %) in SIS group and 96 % for TVT. Post-operative FSFI score improves significantly and were comparable in both groups (SIS pre-operative 24.30 ± 4.56 to 27.22 ± 4.66 (P < 0.001) post-operative; TVT 24.63 ± 6.62 to 28.47 ± 4.41, respectively). CONCLUSIONS The SIS procedure appears to be as effective in improving incontinence-related quality of life and sexual function as the TVT through 6 months of post-operative follow-up. No differences in complications and sexual function were demonstrated between the groups.
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Affiliation(s)
- Gert Naumann
- Department of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany
| | - Joscha Steetskamp
- Department of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany
| | - Mira Meyer
- Department of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany
| | - Rosa Laterza
- Department of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany
| | - Christine Skala
- Department of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany
| | - Stefan Albrich
- Department of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany
| | - Heinz Koelbl
- Department of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany
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