Health Policy Advisory Committee on
Technology
Technology Brief
Single-incision mini-sling system for female stress urinary
incontinence
© State of Queensland (Queensland Department of Health) 2013
This work is licensed under a Creative Commons Attribution Non-Commercial No Derivatives 2.5 Australia licence. In essence, you are free to copy and communicate the work in its current form for non-commercial purposes, as long as you attribute the authors and abide by the licence terms. You may not alter or adapt the work in any way.
To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/2.5/au/. For further information, contact the HealthPACT Secretariat at:
HealthPACT Secretariat
c/o Clinical Access and Redesign Unit, Health Service and Clinical Innovation Division Department of Health, Queensland
Level 13, Block 7
Royal Brisbane and Women’s Hospital HERSTON QLD 4029
Postal Address: GPO Box 48, Brisbane Qld 4001
Email: HealthPACT@health.qld.gov.au Telephone: +61 7 3646 9100
For permissions beyond the scope of this licence contact: Intellectual Property Officer, Queensland Health, GPO Box 48, Brisbane Qld 4001, email ip_officer@health.qld.gov.au, phone (07) 3234 1479. Electronic copies can be obtained from: http://www.health.qld.gov.au/healthpact
DISCLAIMER: This brief is published with the intention of providing information of interest. It is based on information available at the time of research and cannot be expected to cover any developments arising from subsequent improvements to health technologies. This brief is based on a limited literature search and is not a definitive statement on the safety, effectiveness or cost-effectiveness of the health technology covered.
The State of Queensland acting through Queensland Health (“Queensland Health”) does not guarantee the accuracy, currency or completeness of the information in this brief. Information may contain or summarise the views of others, and not necessarily reflect the views of Queensland Health.
This brief is not intended to be used as medical advice and it is not intended to be used to diagnose, treat, cure or prevent any disease, nor should it be used for therapeutic purposes or as a substitute for a health professional's advice. It must not be relied upon without verification from authoritative sources. Queensland Health does not accept any liability, including for any injury, loss or damage, incurred by use of or reliance on the information.
This brief was commissioned by Queensland Health, in its role as the Secretariat of the Health Policy Advisory Committee on Technology (HealthPACT). The production of this brief was overseen by HealthPACT. HealthPACT comprises representatives from health departments in all States and Territories, the Australian and New Zealand governments and MSAC. It is a sub-committee of the Australian Health Ministers’ Advisory Council (AHMAC), reporting to AHMAC’s Hospitals Principal Committee (HPC). AHMAC supports HealthPACT through funding.
This brief was prepared by Robyn Lambert from the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S).
Technology, Company and Licensing
Register ID WP167
Technology name Single-incision Sling System for Female Stress Urinary Incontinence
Patient indication For use in female patients with stress urinary incontinence Description of the technology
Several marketed single-incision mini-sling (SIMS) systems were identified in the writing of this Brief. All identified systems consist of a suburethral sling made of polypropylene surgical mesh and a surgical placement instrument. They are all placed beneath the urethra via a transobturator approach through a single vaginal incision. Figure 1 shows the MiniArc® Single-Incision Sling System (American Medical Systems, Inc., Minnesota, United States of America (USA)).
Figure 1 MiniArc Single-Incision mini-sling1
The slings and their delivery systems are intended for single use only. They have self-fixating tips that allow fixation into the obturator internus muscle, which is located partially within the lesser pelvis and the back of the hip joint. Fixation can also occur in the levator fascia. The placement procedure requires a single vaginal incision of between 1.0 cm and 1.5 cm, and can be performed under local, spinal or general anaesthesia. The procedure is
delivery needle, which is then inserted through the obturator foramen (a hole created by the ischium and pubis bones of the pelvis) and retracted to deploy the sling into the obturator internus muscle. This is repeated with the second sling tip on the contralateral side. Sling tension is controlled by the operator, using the delivery device to advance the sling until the appropriate tension is achieved. Once the sling is deposited, the delivery device is removed and the incision is closed. The slings are permanent implants.
Figure 2 Sling placed beneath the urethra4
SIMS systems are not identical and may differ in the length of the sling, the fixation method, the fixation location and the method of tension adjustment or control.5 Manufacturers recommend that operators have specific training prior to using the systems and that they are familiar with surgical procedures and techniques involving the use of synthetic meshes to treat female stress urinary incontinence. Contraindications for SIMS use include
pregnancy, suburethral or periurethral areas with active infection or signs of tissue necrosis, sensitivity or allergy to polypropylene mesh products, coagulopathy, renal insufficiency, compromised immune system, planned pregnancy, urinary tract infection or obstruction, and contraindications to surgery. Previous radiotherapy is a partial contraindication for use of SIMS.1, 5
Company or developer
Several manufacturers of SIMS systems were identified. The first SIMS system was the TVT-Secur™ device (Ethicon, Inc., Somerville, New Jersey, USA ), it was subsequently withdrawn from all markets in 2012.6 The reason for this is unclear. The second SIMS system introduced was the American Medical Systems, Inc. MiniArc®/MiniArc® Precise, which has been the subject of a number of clinical studies. Information regarding several SIMS systems is listed in Table 1.
Table 1 SIMS systems and manufacturers1, 5, 7, 8
Device name Manufacturer Properties Altis®
Single-Incision Sling System
Coloplast
Humlebaek, Denmark Needle: 2 introducers Mesh size: 1.1 x 7.8 cm
Fixation method: Polypropylene anchor Fixation location: Obturator membrane Intraoperative tightening possible: Yes AJUST®
Adjustable Single-Incision Sling System
C. R. Bard, Inc.
Covington, Georgia USA Needle: Introducer and flexible stylet. The introducer is used to place the sling into the obturator internus and to adjust tension; the stylet is used to lock the sling. Mesh size: Not reported
Fixation method: Polypropylene anchors Fixation location: Obturator membrane
Intraoperative tightening possible: Yes—the sling has adjustable mesh that slides through the anchor allowing for tightening/loosening post placement.
Solyx™ Single-Incision Sling System
Boston Scientific Corporation
Natick Massachusetts, USA Needle: 1 needle and driver Mesh size: 9 cm
Fixation method: Polypropylene mesh carriers Fixation location: Obturator internus muscle Intraoperative tightening possible: Not after device is released; once the sling is deposited in tissue, it cannot be reconnected onto the placement needle for additional tension/adjustment.
MiniArc™ Single-Incision Sling System
American Medical Systems, Inc. Minnetonka Minnesota, USA
Needle: 1 needle and driver Mesh size: 1.1 x 8.5 cm
Fixation method: Permanent self-fixating tips Fixation location: Obturator internus muscle Intraoperative tightening possible: Yes—optional re-docking feature. Minisling ophira™ Single-Incision Sling System Promedon
Córdoba, Argentina Comprises a polypropylene mesh sling and an introducer system (details not specified).
Reason for assessment
Urinary incontinence is a debilitating condition that has physical and psychological implications for a woman’s health and quality of life. SIMS systems may be used as a first-line surgical treatment in the management of female stress urinary incontinence. Stage of development in Australia
Yet to emerge Established
Experimental Established but changed indication or modification of technique
Investigational Should be taken out of use Nearly established
Licensing, reimbursement and other approval
SIMS systems are included on the Australian Register of Therapeutic Goods (ARTG) as Class IIb medical devices. A search of the ARTG revealed inclusions for all identified SIMS systems
(Table 2), with the exception of the AJUST® SIMS system. From the descriptors available on the ARTG, it was unclear whether the AJUST® SIMS system is included on the ARTG.
Additionally, all SIMS systems, with the exception of the AJUST® device, were found on the prosthesis list and have a maximum payable benefit of A$865.
The MiniArc® and MiniArc® Precise SIMS systems are included under the same ARTG number and, in some cases, the SIMS systems are included under the ARTG number associated with the surgical mesh that predated the development and marketing of the corresponding SIMS system.
USA Food and Drug Administration (FDA) 510(k) clearance, CE Mark and Health Canada approval were identified for all SIMS.
Table 2 ARTG and FDA approval of specific SIMS systems9-11
Device name ARTG number and start date Prosthesis list details FDA 510(k) clearance and start date
AJUST® Adjustable Single-Incision
Sling System None identified None identified K092607 start date 20/11/2009 Altis Single-incision Sling System 190173
start date 1/10/2011 CT018 Maximum benefit: $865.00 Product category: Urogenital
K121562
start date 2/11/2012 Minisling ophira™ Single-Incision
Sling System 165126* ET060 Maximum benefit: $865.00 Product category: Urogenital
K110420
start date 08/05/2012 MiniArc Single-Incision Sling System 144354
Start date 6/09/2007 AM049 Maximum benefit: $865.00 Product category: Urogenital
K070065
Start date 01/03/2007 MiniArc Precise Single-Incision Sling
System 144354 Start date 6/09/2007 AM055 Maximum benefit: $865.00 Product category: Urogenital K121641 start date 10/06/2010 Solyx Single-Incision Sling System 104326
start date 30/06/2004 BS154 Maximum benefit: $865.00 Product category: Urogenital
K081275
start date 27/08/2008
ARTG: Australian Register of Therapeutic Goods. FDA: Food and Drug Administration. * Number identified from the prosthesis list.
There are several Medical Benefits Schedule (MBS) items that include the use of or removal of slings for the treatment of urinary incontinence (Table 3). It is unclear whether these items cover the placement of SIMS systems.
Table 3 MBS listings for procedures utilising surgical mesh for SUI, including fees and benefits
Item number Description Fee Benefits 35599 STRESS INCONTINENCE, sling operation for, with or without mesh or
tape, not being a service associated with a service to which item 30405 applies
Multiple Services Rule (Anaes.) (Assist.)
$674.50 75% $505.90
36811 CYSTOSCOPY with insertion of urethral prosthesis Multiple Services Rule (Anaes.)
$323.40 75% = $242.55 85% = $274.90 37340 URETHRAL SLING, division or removal of, for urethral obstruction or
erosion, following previous surgery for urinary incontinence, vaginal approach, not being a service associated with a service to which item number 37341 applies
Multiple Services Rule (Anaes.) (Assist.)
$425.00 75% = $318.75
37341 URETHRAL SLING, division or removal of, for urethral obstruction or erosion, following previous surgery for urinary incontinence, suprapubic or combined suprapubic/vaginal approach, not being a service associated with a service to which item number 37340 applies Multiple Services Rule (Anaes.) (Assist.)
$911.30 75% = $683.50
All costs are in Australian dollars. SUI: Stress Urinary Incontinence
Australian Therapeutic Goods Administration approval
Yes ARTG number (s): 190173, 144354, 104326,
165126 No
Not applicable
Technology type Device
Technology use Therapeutic Patient Indication and Setting
Disease description and associated mortality and morbidity
Urinary incontinence (UI), the involuntary loss of urine from the bladder, is considered a symptom of lower urinary tract dysfunction. Urine is retained in the bladder by the dual action of the urethra and its sphincter, which acts as a closure mechanism. The pelvic floor muscles provide support to the bladder and the urethra. Continence requires correct functioning of the relevant anatomy as well as the involvement of the nervous system; stress urinary incontinence (SUI) occurs as a result of abnormalities in the urethra, the bladder or both.12
Female SUI is the most common form of urinary incontinence and is characterised by the involuntary leakage of urine in response to elevated abdominal pressure caused by exertion, effort, sneezing or coughing.12 Intrinsic urethral sphincter deficiency and hypermobility or significant displacement of the urethra and bladder neck during exertion have been
implicated in the pathophysiology of SUI.12 There does not appear to be a validated, standard test to distinguish between these mechanisms and in women, the two may co-exist.
The aetiology of the processes underlying abnormal urethral function in women is not well understood. This is, in part, due to the lack of a standardised definition and measure of severity for UI, as well as geographic variation in epidemiologic methodology and patient demographics.13 Additionally, confounding factors make it difficult to draw conclusions about associations between a potential risk factor and incontinence.14 Because of this, there is a paucity of information regarding the prevalence of and aetiology of UI and, therefore, SUI. In women, risk factors for SUI include pregnancy, vaginal delivery, diabetes mellitus and advancing age.14 SUI may also be related to the strength of the pelvic floor muscles. Injury to the urethral area, some medications and pelvic surgery have also been implicated in the development of SUI.13
Diagnosis of UI and subsequent management involves taking a patient history, conducting a physical examination and assessing the patient’s quality of life and desire for treatment. Further tests which may be used to establish a diagnosis of SUI include urodynamic testing and urinalysis.13 Women with UI may also present with pelvic organ prolapse. This will be taken into account when planning treatment for SUI as women with severe pelvic organ prolapse may not be eligible for the SIMS procedure.
UI is a debilitating condition with physical and psychological implications for a woman’s health and quality of life. Symptoms of UI can be embarrassing, bothersome and anxiety-provoking; this can impact on an individual’s ability and willingness to participate in social activities resulting in social isolation. UI can also impact on the internal emotional wellbeing of patients; persons with severe incontinence have reported a higher likelihood of negative feelings, lower energy levels and poorer overall health than those who do not have severe incontinence.14
Number of patients
As there is no universal definition of UI, estimates of its prevalence vary and may not be specific to SUI. Consequently, there is little consensus regarding the true burden of female SUI. A 2006 report from the Australian Institute of Health and Welfare (AIHW)15 estimated that:
Approximately 2.8 per cent of the Australian adult population experienced severe incontinence (urinary and faecal). This included 240,800 people who experienced urine leakage of more than a few drops at least several times a week.
Around 723,100 Australians experienced moderate urinary incontinence (urine leakage several times a month or small-volume leakage).
Approximately 2,877,500 Australians experienced slight urinary incontinence (urine leakage less than once per month and/or leaked only small volumes).
In the published literature, prevalence estimates of urinary incontinence in women have a wide range. Most studies reported some degree of urinary incontinence in 25 to 45 per cent of women studied.16 A recent report from the AIHW on incontinence in Australia provides a summary of international prevalence estimates for UI. One review which presented the best available evidence estimated that UI has a prevalence of between 7 and 37 per cent in females aged 20 to 39, between 31 and 48 per cent in females aged 40 to 59, between 30 and 61 per cent in females aged 60 to 79 and between 37 and 63 per cent in females aged 80 and over.16 Difficulties in defining UI, its severity and methods of measurement have resulted in wide variations in estimates.
Information from the AIHW data cubes shows that for the 2009 to 2010 period there were 8,514 hospital separations for stress incontinence.17 Relevant MBS items for surgical interventions for SUI and their utilisation for the 2011-2012 period are presented below. These figures only include private patient data.
Table 4 Utilisation of MBS items for stress urinary incontinence from July 2011 to June 2012
Item number Description Number of procedures 36811 CYSTOSCOPY with insertion of urethral prosthesis 102 35599 STRESS INCONTINENCE, sling operation for, with or without mesh or tape, not being a
service associated with a service to which item 30405 applies 5,879 37340 URETHRAL SLING, division or removal of, for urethral obstruction or erosion, following
previous surgery for urinary incontinence, vaginal approach, not being a service associated with a service to which item number 37341 applies
325 37341 URETHRAL SLING, division or removal of, for urethral obstruction or erosion, following
previous surgery for urinary incontinence, suprapubic or combined suprapubic/vaginal approach, not being a service associated with a service to which item number 37340 applies
47
Speciality Urogynaecology
Technology setting General Hospital, Ambulatory Care Impact
Alternative and/or complementary technology
SIMS systems are an alternative to the surgical insertion of standard suburethral slings for stress urinary incontinence.
Current technology
Treatment of SUI includes both surgical and nonsurgical interventions. Conservative therapy may consist of:
Pelvic floor muscle training—generally offered as a first-line conservative therapy Vaginal cones—may be offered as a first-line therapy in women prepared to use them
Electrical stimulation in women with no contraindications Pharmacological intervention.13
Behavioural, exercise and pharmacological therapy for SUI may assist in the management of symptoms; however, these interventions are not considered curative. Women who have failed conservative management and are bothered by the symptoms of SUI may undergo surgical therapy. Prior to surgical intervention, patients are assessed to determine whether pelvic organ prolapse is present and to confirm the diagnosis of SUI.13
Surgical treatments for SUI are varied and the choice of intervention is guided by surgeon preference and experience, the physical characteristics of the patient and coexisting medical conditions. Surgical therapies for SUI include (but are not limited to):
Laparoscopic or open colposuspension—this procedure involves surgically elevating the bladder neck behind the anterior pubic bone.
Vaginal anterior repair and bladder neck needle suspension—a needle is inserted vaginally or through the abdomen into the retropubic space. Sutures are looped through the tissue on each side of the bladder neck to provide support.
Periurethral injections—bulking materials are injected into the walls of the urethra to provide extra pressure on the urethra, making it better able to withstand elevated abdominal pressure.
Suburethral sling placement—described below.
Minimally invasive suburethral sling placement—described below. SIMS – described below.
Suburethral sling placement (standard mid-urethral slings)
Traditional suburethral sling operations, referred to as standard mid-urethral slings (SMUS), use autologous, biological or synthetic materials to form a sling that is tunnelled under the urethra and attached to the rectus or iliopectineal ligaments. The surgery uses a combined abdominal and vaginal approach and may require up to three small incisions.12
Minimally invasive suburethral sling placement
Minimally invasive sling operations are similar to the procedure described above; however, they require only two incisions and do not require suture fixation. Slings are generally made of a prolene mesh and may be referred to as polypropylene tape or vaginal tape. Slings may also be provided in kits which contain accessories for anchoring the ends of the sling in tissue.18
The procedure is performed using a retropubic or transobturator approach. In the retropubic approach two needles are passed through the retropubic space from the
abdomen to the vagina or vice versa. Post procedural cystoscopy is recommended to check for bowel perforation. The needles are used to place the sling beneath the urethra without sutures. The transobturator route involves the insertion of a sling, positioned at the mid urethra, through a groin and vaginal incision. This route avoids the retropubic space12; because of this, cystoscopy may not be necessary. These procedures are performed under local anaesthesia. The difference between this procedure and the SIMS procedure is that the SIMS procedure requires only a single incision.
Single-incision mini-slings
The single-incision mini-sling procedures were developed with the aim of reducing the postoperative morbidity associated with surgery for UI.19 The SIMS systems may be performed in outpatient facilities (ambulatory care) under local anaesthesia.
A Cochrane review comparing minimally invasive sling operations to traditional suburethral sling placement found that minimally invasive slings were as effective (cure rates of
approximately 80%) as traditional slings, open retropubic colposuspension and laparoscopic colposuspension in the short term. The authors also concluded that the minimally invasive approaches were associated with less post-operative complications and that the evidence base was limited by short-term follow-up periods.12
Adverse events associated with minimally invasive sling procedures include postoperative pain, vascular and nerve damage, and organ injury.
Diffusion of technology in Australia
SIMS systems are widely available in Australia and are included on the prosthesis list. The products are widely available in the private sector and funding-dependent in the public sector. Within Australia, outpatient treatment is rare due to differences in funding models as compared to the United Kingdom (UK) and USA where ambulatory care appears to be the primary mode of treatment delivery in SIMS procedures.
International utilisation
Country Level of Use
Trials underway or completed
Limited use Widely diffused
Australia USA UK Canada France Belgium Germany Slovenia Spain South Africa
Cost infrastructure and economic consequences
The economic considerations surrounding minimally invasive sling procedures and single-incision mini-slings are not well documented in the published literature.12, 20 The product information regarding the SIMS systems indicated that the operator of the system should have training and be experienced in standard sling placement.
Systems are sold as single-use items and may be inserted under local anaesthesia on an outpatient basis. It is unclear whether the SIMS technologies provide a cost saving to patients and healthcare systems over standard minimally invasive sling procedures. SIMS systems are available via the prosthesis list, with a maximum payable benefit of A$856.00. Ethical, cultural or religious considerations
No ethical, cultural or religious considerations were identified in the published literature. Evidence and Policy
Safety and effectiveness
In selecting literature for inclusion in this brief, priority was given to level II evidence over lower levels of evidence; consideration was also given to the need to compare SIMS to SMUS. As a result, three randomised controlled trials (RCTs) were selected for inclusion (Table 5). In two of the three studies included, there was a treatment arm utilising the TVT-Secur™ system which has subsequently been taken off the market and does not have ARTG approval. Consequently, data from the TVT-Secur™ treatment arms were not extracted. Non-English language literature was also excluded. One systematic review with a meta-analysis was identified and subsequently excluded as the meta-meta-analysis contained data from
studies using the TVT-Secur™ system which could not be separated from the aggregate data.20
Table 5 Details of the included studies in order of appearance
Study Oliviera et al, 201121 Mostafa et al, 201322 Palomba et al, 201223
Level of evidence II* II II*
Number of patients§ 60 (30 in each arm)§ 137 80 (40 in each arm)§
Patient details Women with clinically and urodynamically proven SUI associated with urethral hypermobility
Women admitted for SMUS as a sole procedure, with
urodynamic SUI, having failed or declined conservative management were excluded
Women with SUI or MUI who remained incontinent after conservative management. In the presence of MUI only, patients with persistent SUI (clinically demonstrable) were enrolled
Comparative treatment TVT-O™ (SMUS), MiniArc (SIMS) AJUST® and TVT-O AJUST® and MiniArc Comparison of patient
populations
No statistical comparisons were made. Baseline demographics appear similar between groups in terms of age
None reported. Baseline characteristics of the patients are presented in a table
No statistically significant differences were detected between treatment groups Randomisation Details not provided Stratified by centre using
number allocation software; allocation to each group was performed via telephone
The random allocation sequence was made in single blocks using a single sequence of random assignment obtained using a computer-generated randomisation list Intervention SMUS: TVT-O
SIMS: MiniArc
SMUS: TVT-O SIMS: AJUST®
SIMS: AJUST®, and MiniArc Follow-up 6 and 12 months 4–6 months 30 days
Conflict of interest None Not reported None
*Includes patients treated with TVT-Secur; §Number excludes patients treated with TVT-Secur; SUI: stress urinary incontinence; MUI: mixed urinary incontinence
A summary of the FDA meeting of the Obstetrics and Gynecology Devices Advisory
Committee on the topic of surgical mesh for treatment of women with pelvic organ prolapse and SUI that contained relevant information was also identified (see other issues).
Oliviera et al 201121
An RCT (level II Interventional evidence) was conducted at a single centre in Portugal by Oliviera et al. (2011). Consecutive patients (n=90) were recruited upon diagnosis of
urodynamically-proven SUI associated with urethral hypermobility. Women were excluded if they had undergone previous surgery for SUI, had genital prolapse stage two or higher, complained of urgency or frequency of urination or nocturia, or demonstrated detrusor overactivity. Patients receiving the transobturator vaginal tape (TVT-O) underwent
placement of a synthetic vaginal tape underneath the urethra using the technique described by de Leval (2003).24 Patients receiving the SIMS (MiniArc) underwent mini-sling placement as described by Moore et al (2009)25 and Kenelley et al (2010).26 All participating surgeons had a minimum experience of 30 cases for each procedure.
The evaluation included a 6- and 12-month follow-up, with no patients lost to follow-up. Evaluation consisted of visits at the follow-up points and patients responding to questions about lower urinary tract symptoms including leakage, pain and complications. A cough test was also performed at 12 months. Baseline and 6-month follow-up assessment also
included the completion of the King’s Health Questionnaire (KHQ). The women included had a mean age of 27.2 (SD 11.7) years in the TVT-O group and 29.8 (SD 5.4) years in the
MiniArc® group. At baseline, there were no significant differences in patient characteristics between the treatment groups. Methods of randomisation were not reported and blinding to the intervention for assessor and patient was assumed to be not possible.
Safety
No cases of intra-operative major bleeding, haematuria, urethral injury or vaginal
perforation were observed. The post-operative pain score (first 24 hours) was assessed by a 0–10 visual analogue scale (VAS) and was higher in the TVT-O group than in the MiniArc® group. Nine patients undergoing TVT-O experienced complications, two of whom required surgical intervention. Six complications occurred in the MiniArc® group, with none requiring surgical intervention (Table 6).
Table 6 Adverse events associated with the TVT-O and MiniArc procedure
Outcome TVT-O MiniArc Mean pain score (SD) 4.5 (2.6) 1.0 (1.0) Median pain score (range) 4 (1–10) 1 (0–3) De novo urgency 5 3 Prolonged thigh pain 2 1 Transient urinary retention 0 1 Urinary tract infection 0 1 Complications requiring surgical
intervention
Three surgeries on two patients consisting of sling transections due to recurrent urinary retention
0
SD: standard deviation
Effectiveness
Effectiveness was measured by rates of cure and improvement and KHQ scores 12 months after surgery. Cure was defined as the patients ceasing to wear incontinence protection and a negative cough test. In both the MiniArc® and the TVT-O treatment arms cure rates were greater than 80 per cent. Improvement was considered to be a positive cough test or maintenance of SUI associated with at least a 50 per cent decrease in the number of incontinence protections necessary and the patient being “satisfied with the result of the surgery”. The results are presented in Table 7.
Table 7 Assessment of cure, improvement or failure at 12 months21
TVT-O MiniArc Cured, n/N (%) 25/30 (83%) 26/30 (87%) Improved, n/N (%) 3/30 (10%) 2/30 (7%) Failed, n/N (%) 2/30 (7%) 2/30 (7%)
n/N: number of patients with complication/total patients treated
This RCT also reported the percentage of patients with at least 15 points of improvement on the KHQ domains at six months post procedure. More than 80 per cent of patients in both the TVT-O and MiniArc® groups reported an improvement of at least 15 points in six of the nine KHQ domains at six months after treatment, compared with baseline (Figure 3).
GHP: global health perception; Impact: incontinence impact; Role: role limitation; Phys: physical limitation; Soc: social limitation; Pers: personal limitation.
Figure 3 KHQ score improvement at 6 months from Oliviera et al 201221
Mostafa et al 2012
An RCT (level II Interventional evidence) was conducted in six centres in the UK. All eligible women admitted for SMUS as a sole procedure were invited to participate. The enrolled women had urodynamic SUI, having failed or declined pelvic floor training (n=137).
Exclusion criteria were women with pelvic organ prolapse (greater than stage two), previous surgery for incontinence, concomitant surgery, previous pelvic irradiation and neurological conditions. Patients received a SIMS (AJUST®) procedure under local anaesthesia or a SMUS procedure under general anaesthesia. Each procedure was performed using the standard insertion protocol described by de Leval (2003)24 (TVT-O™) and Abdel-Fattah et al. (2012)27 (AJUST®). Participating surgeons had performed over 100 SMUS procedures and had attended a formal training session for the AJUST® procedure, as well as having completed 12 to 20 SIMS procedures. Cystoscopy was performed in all cases.
Baseline assessment included a detailed history, pelvic exam, urodynamic assessment and filling and voiding cystometry. All women completed the following validated symptom severity and quality-of-life questionnaires: the International Consultation of Incontinence Questionnaire—Frequency of Lower Urinary Tract Symptoms (ICIQ-FLUTS), the ICIQ-short form (ICIQ-SF), the Urgency Perception Scale (UPS), the KHQ, and the Pelvic Organ
Prolapse/Incontinence Sexual Function Questionnaire (PISQ-12). At the follow-up assessment (four to six months), patients completed the questionnaires, a 3-day urinary diary, a standing cough-stress test, a bladder scan for assessment of post-voiding residual volume, a vaginal examination and a Patient Global Impression of Improvement
questionnaire (PGI-I). Postoperative pain was measured at 30 minutes, three hours, four days and four weeks postoperatively. All patients completed a minimum of four months of follow-up. Patients in the SIMS group had a mean age of 52.6 (SD 11.2) years and patients in the TVT-O group had a mean age of 49.4 (SD 8.8) years. No statistical comparison of patient baseline characteristics was reported.
Safety
There were no major operative or perioperative complications in either study group. Perioperative and postoperative data are shown in Table 9. There were no statistically significant differences between the treatment groups for any of the parameters. The pain profile data are shown in Table 8. Women in the AJUST® group experienced less
postoperative pain than the women in the TVT-O group at up to four weeks after treatment (p<0.001).
Table 8 Pain profile from 30 minutes to 4 weeks after surgery
Postoperative pain score, median (IQR)
TVT-O AJUST® P value 30 minutes 1.00 (0.00,5.00) 0.00 (0.00,0.00) <0.001 3 hours 3.00 (1.00,5.00) 0.00 (0.00,1.00) <0.001 At discharge 3.00 (1.00,4.75) 0.00 (0.00,1.00) <0.001 4 days 2.00 (0.00,4.00) 0.00 (0.00,2.00) 0.001 4 weeks 0.00 (0.00,0.00) 0.00 (0.00,0.00) 0.0119 Total pain profile 2.00 (0.00,4.00) 0.00 (0.00,0.00) <0.001
Table 9 Perioperative and postoperative events associated with the TVT-O and AJUST® procedures
TVT-O (n=68) AJUST® (n=69) Estimated blood loss
<50 mL 28 (41.8%) 45 (65.2%) 50 to 100 mL 36 (52.9%) 22 (31.9%) >100 mL 3 (4.4%) 2 (2.9%) Missing data 1 (1.5%) Perioperative complications, n(%) Bladder/urethral injuries 0 0 Difficulties in sling insertion 2 (2.9%) 4 (5.8%) Severe postoperative pain score > 5/10 5 (7.4%) 2 (2.9%) Voiding dysfunction requiring catheterisation 8 (11.8%) 3 (4.3%) CISC at 3 months 2 (2.9%) 1 (1.4%) Vaginal erosion 2 (2.9%) 1 (1.4%) Worsening of postoperative urgency and/or de novo urgency 6 (8.8%) 15 (21.7%)
CISC: clean intermittent self-catheterisation
Effectiveness
A number of intra-operative and post-operative outcomes were reported. The proportion of patients in the AJUST® group achieving patient-reported and objective success rates at four to six months was lower than in the TVT-O group; however, the difference was not found to be statistically significant at four to six months follow-up (Table 10). The operating time was 33.8 (SD 9.07) minutes in the TVT-O group and 32.2 (SD 9.02) minutes in the AJUST® group (p=0.30). Women in the AJUST®group experienced a shorter hospital stay and earlier return to work and normal activities as compared with the TVT-O group. Notably, the women who underwent the SIMS procedure returned to work a median of one week earlier than women who underwent the SMUS procedure. More patients in the AJUST® group experienced de novo or worsened urge incontinence than in the TVT-O group (15 versus 6 patients; Table 9).
Table 10 Patient reported and objective outcomes
Patient reported and objective outcomes TVT-O AJUST® P value Patient reported success (PGI-I) 62 (91.2%) 59 (85.5%) 0.44 Mean change in ICIQ-SF, mean ± SD 12.32 ± 4.50 11.20 ± 5.59 0.23 Objective cure (negative cough stress test) 66 (97.1%) 62 (89.9%) 0.17 Patient satisfaction on visual analogue
scale, median (IQR)
9 (8,10) 10 (8,10) 0.24 Recommend to a friend, n (%) 61 (89.7*) 65 (94.2#) 0.98
Time to return to normal activities (days), median (IQR)
8 (5.25,14) 7 (3,14) 0.03 Time to return to work (days), median (IQR) 21 (11,28) 14 (7,21) 0.006 Hospital stay (hours), median (IQR) 4.42 (3.16,5.56) 3.65 (2.49, 4.96) 0.07 Changes in urgency on UPS
Cure of urgency 20 (29.4%) 19 (27.5%) 0.96 Improvement of urgency 16 (23.5%) 14 (20.3%) 0.80 No changes 26 (38.2%) 20 (29.0%) 0.33 Worsening of urgency 3 (4.4%) 5 (7.2%) 0.72 De novo urgency 3 (4.4%) 10 (14.5%) 0.09 Median change ICIQ-FLUTS, median (IQR)
Filling domain 1 (0, 3) 1 (0,2.5) 0.48 Voiding domain 0 (-1, 0.75) 0 (-1,1) 0.60 Incontinence domain 9 (6,11) 8 (5,11) 0.15 Total ICIQ-FLUTS 9 (5, 12.5) 9.5 (6,14) 0.25
PGI-I: Patient global impression of improvement; ICIQ-SF: International Consultation of Incontinence Questionnaire—Short Form; VAS: Visual Analogue Scale; UPS: Urgency perception scale; ICIQ-FLUTS: International Consultation of Incontinence Questionnaire—Frequency of Lower Urinary Tract Symptoms; IQR: interquartile range; * reported as 91.0% in the study; # reported as 92.6% in the study.
Palomba et al 201223
An RCT (Level II Interventional evidence) was conducted in multiple centres in Italy by Palomba et al. (2012). Women were screened as part of a wider protocol study of SUI or mixed urinary incontinence (MUI) and those choosing to be managed with SIMS were enrolled (n=120). Definition of SUI was involuntary loss of urine when the intravesical pressure exceeded the maximum urethral pressure in the absence of detrusor contraction. Definition of MUI was involuntary loss of urine with effort or physical exertion or on
sneezing or coughing associated with urgency. When MUI was present, inclusion criteria was clinically demonstrable SUI under oral antimuscarinic therapy. Additionally, only
women who remained incontinent after conservative management were enrolled. Exclusion criteria were extensive and included post-void residual urine of more than 100 mL, intrinsic sphincter insufficiency, detrusor instability score greater than seven, pelvic organ prolapse
incontinence surgery, lower urinary tract anomaly, concurrent urinary tract infection (UTI) or more than three UTI episodes per year, neurogenic disease, desire for future
childbearing, and pregnancy or less than 12 months post-partum. Further exclusion criteria are listed in the article by Palomba et al (2012).23 The patients received a SIMS (MiniArc, TVT-Secur or AJUST®) with surgical procedures performed by the same surgeon and according to the suggestions of the manufacturer. All surgical procedures were performed under local anaesthesia with light conscious sedation. Cystoscopy to verify bladder integrity was performed in all cases.
Follow-up evaluations were performed at 30 days post-surgery. Evaluation included a clinical assessment, including an evaluation of de novo(Detrusor Instability Score [DIS] > 7) or worsened urge incontinence (DIS >7 and change of 2 points from baseline). The follow-up visit also included an assessment of patient quality of life, sexual function and disease-specific impact of UI on quality of life. Patients in the AJUST® group had a mean age of 62.5 (SD 12.3) years, patients in the MiniArc group had a mean age of 64.2 (SD 13.8) years and patients in the TVT-Secur group had a mean age of 63.6 (SD 10.9) years. No statistically significant differences amongst treatment groups were found. Patients were randomised by computer-generated lists and both patients and data assessors were masked to the SIMS assignment. Randomisation was stratified by the centre using number allocation software and allocation to each group was performed by telephone. Blinding of the patients was not possible; however, the follow-up assessment was performed by an independent researcher blinded to allocation.
Safety
In this RCT, no cases of intraoperative haemorrhage occurred in the MiniArc or AJUST® groups. The number of patients using analgesic tablets during the first 30 days post-surgery and the number of tablets used were similar amongst all treatment groups (p>0.05). One patient in the AJUST® group and four in the TVT-Secur group were not discharged on the same day as surgery due to postoperative pain. Seven complications occurred in the AJUST® group and two occurred in the MiniArc group. Post-operative complications did not require pharmacological or surgical intervention (Dindo Grade I)28 and a statistically significant difference in the number of complications was identified between the AJUST® and MiniArc arms (p<0.05). No tape erosion or extrusion was reported within the 30-day follow-up period (Table 11).
Table 11 Safety of the SIMS procedure as reported in Palomba et al 201223
AJUST® (n=40) MiniArc (n=40) Mean intraoperative blood loss (mL) (SD) 31.2 (20.8) 32.4 (13.6) Mean Δ Hb (g/dl) (SD) 0.5 (0.3) 0.5 (0.2) Mean analgesic vials, n (SD) 1.7 (1.3) 1.2 (1.2) Mean post-operative pain (SD) 5.3 (3.8) 5.0 (3.5) Use of analgesic tablets, n (%) 22 (55%) 20 (50%) Mean analgesic tablets, n (SD) 15.9 (9.7) 15.1 (8.8) Total postoperative complications, n (%) 7 (17.5%) 2 (5%)* Urinary tract infections, n (%) 1 (2.5%) 0 Needed intermittent self-catheterisation
due to voiding dysfunction, n (%)
2 (5%) 0 De novo or worsened urge UI, n (%) 3 (7.5%) 2 (5%)
*p<0.05 as compared to the AJUST® group;Δ Hb (g/dl): change in haemoglobin; n: number of events, SD = standard deviation
Effectiveness
Several intra-operative and post-operative outcomes were reported. Rates of cure and/or improvement were not reported although patient satisfaction was. Patient satisfaction was measured using a visual analogue scale which was administered at hospital discharge. Operative time, feasibility and degree of surgical difficulty were reported. Feasibility was measured as the number of surgeries completed under local anaesthesia out of the total number of surgeries. De novo (a DIS score higher than 7) or worsened urge incontinence (DIS score higher than 7 and change from baseline of more than 2 points) is reported in Table 11; the results were similar between groups.
No statistically significant difference in operative time between the treatment arms was detected (p=0.655). Feasibility was deemed higher for the MiniArc group in comparison with the AJUST® group; the surgery was completed under local anaesthesia in 39 (97.5%)
patients in the MiniArc group as compared to 30 (75.0%) patients in the AJUST® group. The use of general anaesthesia was due to uncontrollable pain in all cases. Surgical difficulty was also lower in the MiniArc group than in the AJUST® group (4.3 [SD 2.2] versus 5.7 [SD 3.0]). Overall, mean patient satisfaction scores at discharge were higher in the MiniArc group than in the AJUST®group (8.6 [SD 3.0] versus 7.5 [SD 2.7]). This difference was found to be
statistically significant (p<0.05). Economic evaluation
No economic evaluations regarding the cost effectiveness of SIMS systems were identified in the literature.
Ongoing research
A total of seven clinical trials, currently underway, were identified from searches of
www.ClinicalTrials.gov and the Australian and New Zealand Clinical Trials Register (ANZCTR) (Table 12). The trials identified include females, 18 years or older with SUI. Primary
outcomes measured included improvement in incontinence. Improvement in incontinence measures include 24 hour pad weight tests, cough stress tests and subject self-reported improvement.
Table 12 Registered clinical trials underway
Trial Identifier Trial status Interventions N Study design Estimated completion date NCT01272284
USA, Belgium, Canada, France, Germany, Slovenia, South Africa, Spain, UK
Recruiting The Altis Single-incision
Sling System 113 Multicentre case series January 2014
NCT01290796
USA Active, not recruiting The AJUST® Single-incision Sling System 150 Single centre case series June 2013 NCT01699425
Spain Not yet recruiting The AJUST® Single-incision Sling System versus transobturator sling
140 Multicentre randomised
controlled trial October 2014 NCT01784588
Not provided Not yet recruiting Solyx Single Incision Sling System versus Obtryx II Sling System
280 Non-randomised
comparative study December 2016 NCT01799122
Canada Not yet recruiting The MiniArc Precise versus transvaginal obturator sling
NR Single centre randomised comparative study
February 2015
ACTRN12612000314820
Australia Recruiting The Monarc versus the MiniArc systems 50 Randomised comparative study, Not reported ACTRN12611001151921
Australia Recruiting The MiniArc system compared to tension-free vaginal tape.
230 Randomised comparative study
Not reported
Other issues
There are a range of single-incision mini-sling devices marketed for the treatment of female SUI. Each device has unique features such as different sling lengths and fixation methods, but it is unclear how these differences affect the clinical performance of each device. The relative benefits and harms of each system, as compared to other mini-sling devices, is poorly characterised in the available literature. There is a large number of case series and non-randomised comparative studies evaluating the MiniArc system as well as the AJUST® and TVT-Secur (no longer marketed) systems; however, very limited data exist for the Solyx, Altis and Minisling Ophira systems.
Follow-up periods in the included studies were short and, in the broader literature, follow-up periods longer than 12 months were rare. Short follow-follow-up times may not be sufficient to capture outcomes such as tape erosion or durability. The evidence available was also limited by the small patient numbers, with the largest cohort being 69 women in a single treatment arm. Two of the three included studies did not report any power calculation. Mostafa et al (2012)22 reported that their trial was sufficiently powered to show a clinically significant one point difference in pain scores between the trial arms.
A further consideration is the issue of patient selection for SIMS procedures. The literature reported on women with SUI and MUI, but excluded women who had undergone prior anti-incontinence surgery or who had intrinsic sphincter deficiency. It is unclear whether SIMS have a broader role in the management of women with SUI previously treated with surgery. Further study is likely to be required to establish the comparative performance of SIMS against SMUS in the long term and to define the role of SIMS in the management of women with SUI.
Obstetrics and Gynecology Devices Advisory Committee (US) on the safety and efficacy of surgical mesh for SUI
In 2011, the FDA convened the Obstetrics and Gynecology Devices Advisory Committee to discuss the use of surgical mesh for the treatment of SUI. Based on a summary of the
Manufacturer and User Facility Device Experience (MAUDE) database of adverse events, the published literature and a presentation from the manufacturers, the panel consensus was “that the safety and effectiveness of mini-slings is not well understood and that premarket evaluation of new mini-slings should be supported by clinical studies. Such studies should have a control arm of women using a retropubic or transobturator sling with a well-understood risk-benefit profile”. The panel consensus stated that post-market studies should address the safety and effectiveness of currently marketed mini-slings by comparing them with conventional retropubic or transobturator slings using either a randomised or rigorous cohort design with a follow-up period of three to five years.18
In January 2012, the FDA ordered SIMS manufacturers to complete post-market surveillance studies of their products. Manufacturers were also required to conduct premarket studies comparing SIMS with SMUS.
Summary of findings
Three level II studies were included in the Technology Brief. Altogether, these studies
assessed the safety of SIMS procedures in a total of 179 patients. From the included studies, it appears that the feasibility of SIMS procedures in an ambulatory care setting under local anaesthesia is established. Overall serious adverse events following the AJUST®, MiniArc or TVT-O procedures were not observed in the included studies. No major intraoperative
and a total of 41 complications were reported in 179 patients who received a SIMS
procedure. Complications included de novo or worsening urgency (n=23), prolonged thigh pain (n=1), transient urinary retention (n=1), urinary tract infection (n=2), voiding
dysfunction requiring catheterisation (n=5), clean intermittent self-catheterisation (CISC) at three months (n=1) and vaginal erosion (n=1). Post-operative pain was measured differently in each study and generally observed to be lower in the SIMS group than the SMUS group.21,
22
Quality of life questionnaires and measures of patient satisfaction following treatment with the SIMS or SMUS appeared to be similar in all studies. In one RCT, more than 80 per cent of patients in both the TVT-O and MiniArc groups reported an improvement of at least 15 points in six of the nine KHQ domains from baseline to six months after treatment.21 In the two studies which compared the AJUST® or MiniArc SIMS to the SMUS procedure, morbidity tended to be lower in the SIMS treatment arm and differences in efficacy between SIMS and SMUS tended to be small. In one study, the AJUST® and MiniArc SIMS were compared and the results were generally similar between the two groups. The MiniArc device was found to be associated with higher patient satisfaction at discharge and lower surgical difficulty than the AJUST® device. However, this RCT had a follow-up period of only 30 days.23
The included studies were limited by short follow-up times, small patient numbers and an inability to blind patients and/or assessors to treatment. Patients included women with SUI or SUI and MUI and in all cases, women who had undergone previous anti-incontinence surgery were excluded. Whilst all surgeons were reported to have had some experience with SIMS procedures prior to the start of the trials, surgeons are unlikely to have been as experienced with SIMS procedures as with SMUS procedures. The studies included in this brief indicate that in the short term (12 months or less), the MiniArc and AJUST® SIMS appear to be associated with less surgical morbidity than SMUS, can be delivered in an ambulatory care setting and achieve similar success rates.
HealthPACT assessment
SIMS systems were identified on the prosthesis list and appear to have been in use in Australia for some time. In consideration of their wide diffusion in Australia and the low rates of observed morbidity associated with the technology, it is recommended that no further research on behalf of HealthPACT is warranted at this time.
Number of studies included
All evidence included for assessment in this Technology Brief has been assessed according to the revised NHMRC levels of evidence. A document summarising these levels may be accessed via the HealthPACT web site.
Total number of Level II studies 3 References
1. American Medical Systems Inc (2013). MiniArc® Single-Incision Sling System
instructions for use. Available from: http://www.amselabeling.com/en-en/ [Accessed
4 June 2013].
2. Kennelly, M. J., Moore, R. et al (2012). 'Miniarc single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes'. International Urogynecology Journal and Pelvic Floor Dysfunction, 23 (9), 1285-91.
3. Serels, S., Douso, M.&Short, G. (2010). 'Preliminary findings with the Solyx single-incision sling system in female stress urinary incontinence'. Int Urogynecol J, 21 (5), 557-61.
4. Riachi Surgery (unknown). Stress Urinary Incontinence and Treatment Available from:
http://www.riachisurgery.com/stress_urinary_incontinence.htm [Accessed 20 june
2013].
5. American Urological Association. Single incision slings for female stress urinary incontinence. AUA News. 2013 4-8 May 2013.
6. PR Web (2013). Johnson & Johnson’s Ethicon Division to Stop Selling Gynecare
Vaginal Mesh Systems Available from:
http://www.prweb.com/releases/2012/6/prweb9578109.htm [Accessed 4 June
2013].
7. Boston Scientific (2013). Sloyx SIS system. Available from:
http://www.bostonscientific-international.com/Device.bsci?page=HCP_Overview&navRelId=1000.1003&method= DevDetailHCP&id=10112142&pageDisclaimer=Disclaimer.ProductPage,%20Disclaime
r.ReservedForMedProfs [Accessed 21 June 2013].
8. Bard Medical (2013). Ajust Adjustable single incision sling. Available from:
http://bardmedical.com/AJUSTAdjustableSingle-IncisionSling [Accessed 21 June
2013].
9. Department of Health and Ageing (2013). Prosthesis List and Human Tissue Lists. [Internet]. DOHA. Available from:
http://www.health.gov.au/internet/main/publishing.nsf/Content/prostheses-list-pdf.htm [Accessed 6 June 2013].
10. Department of Helath and Ageing (2013). Australian Register of Therapeutic Goods
(ARTG). [Internet]. DOHA. Available from: https://www.ebs.tga.gov.au/ [Accessed 6
June 2013].
11. U.S. Food and Drug Administration (2013). Devices@FDA. [Internet]. U.S. Department of Health & Human Services,. Available from:
http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm [Accessed 6
June 2013].
12. Ogah, J., Cody, D. J.&Rogerson, L. (2011). 'Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women: a short version Cochrane review'. Neurourol Urodyn, 30 (3), 284-91.
13. Thuroff, J. W., Abrams, P. et al (2011). 'EAU guidelines on urinary incontinence'. Eur Urol, 59 (3), 387-400.
14. Australian Institute of Health and Welfare (2013). Incontinence in Australia, AIHW, Canberra, Australia. Report No.: cat. no. DIS 61; ISBN 978-1-74249-437-1.
http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129543602.
15. Australian Institute of Health and Welfare (2006). Australian incontinence data
analysis and development, AIHW, Canberra, Australia. Report No.: cat. no. DIS 44;
ISBN 1-74024-546-6.
16. Buckley, B. S.&Lapitan, M. C. (2010). 'Prevalence of urinary incontinence in men, women, and children--current evidence: findings of the Fourth International Consultation on Incontinence'. Urology, 76 (2), 265-70.
17. Australian Institute of Health and Welfare (2013). Separation statistics by principal
diagnosis in ICD−10−AM, Australia, 2008−09 to 2009−10. [Internet]. AIHW. Available
from: http://www.aihw.gov.au/principal-diagnosis-data-cubes/ [Accessed 6 June 2013].
18. The Obstetrics and Gynecology Devices Panel (2011). Surgical Mesh for the Repair of
Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). [Internet]. Food
and Drug Administration. Available from:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials /MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevic
es/UCM271769.pdf [Accessed 20 June 2013].
19. Kennelly, M. J.&Myers, E. M. (2011). 'Retropubic and transobturator slings: still useful or should all patients be treated with mini-slings?'. Curr Urol Rep, 12 (5), 316-22.
20. Abdel-Fattah, M., Ford, J. A. et al (2011). 'Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications'. Eur Urol, 60 (3), 468-80.
21. Oliveira, R., Botelho, F. et al (2011). 'Exploratory study assessing efficacy and
complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up'. Eur Urol, 59 (6), 940-4.
22. Mostafa, A., Agur, W. et al (2012). 'A multicentre prospective randomised study of single-incision mini-sling (Ajust(R)) versus tension-free vaginal tape-obturator (TVT-O) in the management of female stress urinary incontinence: pain profile and short-term outcomes'. Eur J Obstet Gynecol Reprod Biol, 165 (1), 115-21.
23. Palomba, S., Oppedisano, R. et al (2012). 'A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data'. Eur J Obstet Gynecol Reprod Biol, 163 (1), 108-12.
24. de Leval, J. (2003). 'Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out'. Eur Urol, 44 (6), 724-30.
25. Moore, R. D., Mitchell, G. K.&Miklos, J. R. (2009). 'Single-center retrospective study of the technique, safety, and 12-month efficacy of the MiniArc single-incision sling: a new minimally invasive procedure for treatment of female SUI'. Surg Technol Int, 18, 175-81.
26. Kennelly, M. J., Moore, R. et al (2010). 'Prospective evaluation of a single incision sling for stress urinary incontinence'. J Urol, 184 (2), 604-9.
27. Abdel-Fattah, M., Agur, W. et al (2012). 'Prospective multi-centre study of adjustable single-incision mini-sling (Ajust((R)) ) in the management of stress urinary
incontinence in women: 1-year follow-up study'. BJU Int, 109 (6), 880-6. 28. Dindo, D., Demartines, N.&Clavien, P. A. (2004). 'Classification of surgical
complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey'. Ann Surg, 240 (2), 205-13.
Search criteria to be used (MeSH terms)
urinary incontinence, stress/*surgery[MeSH Terms] suburethral slings[MeSH Terms]
