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Meta-Analysis
. 2017 Jul 26;7(7):CD008709.
doi: 10.1002/14651858.CD008709.pub3.

Single-incision sling operations for urinary incontinence in women

Arjun Nambiar  1 , June D Cody, Stephen T Jeffery, Patricia Aluko
Affiliations
Meta-Analysis

Single-incision sling operations for urinary incontinence in women

Arjun Nambiar et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Urinary incontinence has been shown to affect up to 50% of women. Studies in the USA have shown that up to 80% of these women have an element of stress urinary incontinence. This imposes significant health and economic burden on society and the women affected. Colposuspension and now mid-urethral slings have been shown to be effective in treating patients with stress incontinence. However, associated adverse events include bladder and bowel injury, groin pain and haematoma formation. This has led to the development of third-generation single-incision slings, also referred to as mini-slings.It should be noted that TVT-Secur (Gynecare, Bridgewater, NJ, USA) is one type of single-incision sling; it has been withdrawn from the market because of poor results. However, it is one of the most widely studied single-incision slings and was used in several of the trials included in this review. Despite its withdrawal from clinical use, it was decided that data pertaining to this sling should be included in the first iteration of this review, so that level 1a data are available in the literature to confirm its lack of efficacy.

Objectives: To assess the effectiveness of mini-sling procedures in women with urodynamic clinical stress or mixed urinary incontinence in terms of improved continence status, quality of life or adverse events.

Search methods: We searched: Cochrane Incontinence Specialised Register (includes: CENTRAL, MEDLINE, MEDLINE In-Process) (searched 6 February 2013); ClinicalTrials.gov, WHO ICTRP (searched 20 September 2012); reference lists.

Selection criteria: Randomised or quasi-randomised controlled trials in women with urodynamic stress incontinence, symptoms of stress incontinence or stress-predominant mixed urinary incontinence, in which at least one trial arm involves one of the new single-incision slings. The definition of a single-incision sling is "a sling that does not involve either a retropubic or transobturator passage of the tape or trocar and involves only a single vaginal incision (i.e. no exit wounds in the groin or lower abdomen)."

Data collection and analysis: Three review authors assessed the methodological quality of potentially eligible trials and independently extracted data from individual trials.

Main results: We identified 31 trials involving 3290 women. Some methodological flaws were observed in some trials; a summary of these is given in the 'Risk of bias in included studies' section.No studies compared single-incision slings versus no treatment, conservative treatment, colposuspension, laparoscopic procedures or traditional sub-urethral slings. No data on the comparison of single-incision slings versus retropubic mid-urethral slings (top-down approach) were available, but the review authors believe this did not affect the overall comparison versus retropubic mid-urethral slings.Types of single-incision slings included in this review: TVT-Secur (Gynecare); MiniArc (American Medical Systems, Minnetonka, USA); Ajust (CR Bard Inc., Covington, USA); Needleless (Mayumana Healthcare, Lisse, The Netherlands); Ophira (Promedon, Cordoba, Argentina); Tissue Fixation System (TFS PTY Ltd, Sydney, Australia) and CureMesh (DMed Co. Inc., Seoul, Korea).Women were more likely to remain incontinent after surgery with single-incision slings than with retropubic slings such as tension-free vaginal tape (TVTTM) (121/292, 41% vs 72/281, 26%; risk ratio (RR) 2.08, 95% confidence interval (CI) 1.04 to 4.14). Duration of the operation was slightly shorter for single-incision slings but with higher risk of de novo urgency (RR 2.39, 95% CI 1.25 to 4.56). Four of five studies in the comparison included TVT-Secur as the single-incision sling.Single-incision slings resulted in higher incontinence rates compared with inside-out transobturator slings (30% vs 11%; RR 2.55, 95% CI 1.93 to 3.36). The adverse event profile was significantly worse, specifically consisting of higher risks of vaginal mesh exposure (RR 3.75, 95% CI 1.42 to 9.86), bladder/urethral erosion (RR 17.79, 95% CI 1.06 to 298.88) and operative blood loss (mean difference 18.79, 95% CI 3.70 to 33.88). Postoperative pain was less common with single-incision slings (RR 0.29, 95% CI 0.20 to 0.43), and rates of long-term pain or discomfort were marginally lower, but the clinical significance of these differences is questionable. Most of these findings were derived from the trials involving TVT-Secur: Excluding the other trials showed that high risk of incontinence was principally associated with use of this device (RR 2.65, 95% CI 1.98 to 3.54). It has been withdrawn from clinical use.Evidence was insufficient to reveal a difference in incontinence rates with other single-incision slings compared with inside-out or outside-in transobturator slings. Duration of the operation was marginally shorter for single-incision slings compared with transobturator slings, but only by approximately two minutes and with significant heterogeneity in the comparison. Risks of postoperative and long-term groin/thigh pain were slightly lower with single-incision slings, but overall evidence was insufficient to suggest a significant difference in the adverse event profile for single-incision slings compared with transobturator slings. Evidence was also insufficient to permit a meaningful sensitivity analysis of the other single-incision slings compared with transobturator slings, as all confidence intervals were wide. The only significant differences were observed in rates of postoperative and long-term pain, and in duration of the operation, which marginally favoured single-incision slings.Overall results show that TVT-Secur is considerably inferior to retropubic and inside-out transobturator slings, but additional evidence is required to allow any reasonable comparison of other single-incision slings versus transobturator slings.When one single-incision sling was compared with another, evidence was insufficient to suggest a significant difference between any of the slings in any of the comparisons made.

Authors' conclusions: TVT-Secur is inferior to standard mid-urethral slings for the treatment of women with stress incontinence and has already been withdrawn from clinical use. Not enough evidence has been found on other single-incision slings compared with retropubic or transobturator slings to allow reliable comparisons. A brief economic commentary (BEC) identified two studies which reported no difference in clinical outcomes between single-incision slings and transobturator mid-urethral slings, but single-incision slings may be more cost-effective than transobturator mid-urethral slings based on one-year follow-up. Additional adequately powered and high-quality trials with longer-term follow-up are required. Trials should clearly describe the fixation mechanism of these single-incisions slings: It is apparent that, although clubbed together as a single group, a significant difference in fixation mechanisms may influence outcomes.

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Conflict of interest statement

Arjun Nambiar: June 2014: has received travel and educational grants from Pfizer, Astellas and GSK. July 2017: has received educational grants towards travel and accommodation for attending conferences and meetings from the following pharmaceutical companies: Ferring and Takeda; he is also a member of the EAU guideline panel on Urinary Incontinence.

June D Cody: June 2014 and July 2017: has no conflicts of interest to declare.

Stephen T Jeffery: June 2014: is a speaker for Johnson and Johnson (Women’s Health and Urology) and Bard Medical and is part of a randomised trial on Contasure Needleless. He has received honoraria and travel and educational grants from Bard, Johnson and Johnson and Boston Scientific. July 2017: Has received support from Boston Scientific for support for travel to meetings for the study or other purposes and outside the submitted work has received travel support and honoraria from Boston Scientific and received payment for lectures from Pfizer (on complications of sling surgery) and from Boston Scientific for a lecture at a symposium at an IUGA annual meeting. He has received speaker's fees for Aspen.

Patricia Aluko: July 2017: This project, to add Brief Economic Commentaries to our 'Surgery for UI in women' reviews, was supported by the National Institute for Health Research (NIHR), via the Cochrane Review Incentive Scheme 2016, to the Cochrane Incontinence Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Figures

1
1
PRISMA study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
6.1
6.1. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 1 Number of women with urinary incontinence.
6.2
6.2. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 2 Number of women with no improvement.
6.3
6.3. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 3 Objectve measurement of incontinence.
6.4
6.4. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 4 Condition‐specific health measures.
6.5
6.5. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 5 Duration of operation (in minutes).
6.6
6.6. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 6 Operative blood loss.
6.7
6.7. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 7 Length of in‐patient stay.
6.8
6.8. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 8 Major vascular or visceral injury.
6.9
6.9. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 9 Vaginal wall perforation.
6.10
6.10. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 10 Bladder or urethral perforation.
6.11
6.11. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 11 Urinary retention and need for catheterisation.
6.12
6.12. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 12 Infection related to use of synthetic mesh.
6.13
6.13. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 13 Vaginal mesh exposure.
6.14
6.14. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 14 Mesh extrusion into the bladder or urethra.
6.15
6.15. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 15 Long‐term pain or discomfort.
6.16
6.16. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 16 Dyspareunia.
6.17
6.17. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 17 De novo urgency.
6.18
6.18. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 18 New‐onset detrusor overactivity.
6.19
6.19. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 19 Repeat stress incontinence surgery.
6.20
6.20. Analysis
Comparison 6 Single‐incision sling versus retropubic minimally invasive slings, Outcome 20 Need for any other additional or new surgical procedure to treat complications.
7.1
7.1. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 1 Number of women with urinary incontinence.
7.2
7.2. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 2 Number of women with no improvement.
7.3
7.3. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 3 Objective measurement of incontinence.
7.4
7.4. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 4 Incontinence episodes.
7.5
7.5. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 5 Pad test (weights).
7.6
7.6. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 6 Condition‐specific health measures.
7.7
7.7. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 7 Duration of operation (minutes).
7.8
7.8. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 8 Operative blood loss (mL).
7.9
7.9. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 9 Length of in‐patient stay.
7.10
7.10. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 10 Major vascular or visceral injury.
7.11
7.11. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 11 Bladder or urethral perforation.
7.12
7.12. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 12 Vaginal wall perforation.
7.13
7.13. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 13 Urinary retention and need for catheterisation.
7.14
7.14. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 14 Infection related to use of synthetic mesh.
7.15
7.15. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 15 Vaginal mesh exposure.
7.16
7.16. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 16 Mesh extrusion into the bladder or urethra.
7.17
7.17. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 17 Postoperative pain or discomfort.
7.18
7.18. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 18 Long‐term pain or discomfort.
7.19
7.19. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 19 De novo urgency.
7.20
7.20. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 20 Repeat stress incontinence surgery.
7.21
7.21. Analysis
Comparison 7 Single‐incision sling versus obturator minimally invasive slings, Outcome 21 Need for any other additional or new surgical procedure to treat complications.
8.1
8.1. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 1 Number of women with urinary incontinence.
8.2
8.2. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 2 Number of women with no improvement.
8.3
8.3. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 3 Objectve measurement of incontinence.
8.4
8.4. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 4 Condition‐specific health measures.
8.5
8.5. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 5 Duration of operation (minutes).
8.6
8.6. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 6 Operative blood loss.
8.7
8.7. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 7 Major vascular or visceral injury.
8.8
8.8. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 8 Bladder or urethral perforation.
8.9
8.9. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 9 Vaginal wall perforation.
8.10
8.10. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 10 Urinary retention and need for catheterisation.
8.11
8.11. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 11 Vaginal mesh exposure.
8.12
8.12. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 12 Postoperative pain or discomfort.
8.13
8.13. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 13 De novo urgency.
8.14
8.14. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 14 Repeat stress incontinence surgery.
8.15
8.15. Analysis
Comparison 8 One single‐incision sling versus another, Outcome 15 Need for any other additional or new surgical procedure to treat complications.
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References

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Mostafa 2012 AJS {published data only}
    1. Boyers D, Kilonzo M, Mostafa A, Abdel‐Fattah M. Single incision mini‐slings versus standard mid‐urethral slings in surgical management of female stress urinary incontinence: a cost‐effectiveness analysis alongside a randomised controlled trial (Abstract number 2). Neurourology & Urodynamics 2012;31(6):726‐7. [45457]
    1. Mostafa A, Agur W, Abdel‐All M, Guerrero K, Allam M, Lim C, et al. A multicentre randomised trial of single‐incision mini‐sling (AJUSTc) and tension‐free vaginal tape‐obturator (TVT‐O trademark) in management of female stress urinary incontinence (Abstract number 4). Neurourology and Urodynamics 2011;30(6):806‐8. [42164]
    1. Mostafa A, Agur W, Abdel‐All M, Guerrero K, Lim C, Allam M, et al. A multicentre prospective randomised study of single‐incision mini‐sling (Ajust([REGISTERED])) versus tension‐free vaginal tape‐obturator (TVT‐OTM) in the management of female stress urinary incontinence: pain profile and short‐term outcomes. European Journal of Obstetrics, Gynecology, & Reproductive Biology 2012;165(1):115‐21. [45867] - PubMed
    1. Mostafa A, Agur W, Abdel‐All M, Guerrero K, Lim C, Allam M, et al. Multicentre prospective randomised study of single‐incision midurethral sling (SIMS‐ Ajust∏) versus tension‐free vaginal tape‐obturator (TVT‐OTM) in management of female stress urinary Incontinence (SUI): a minimum of one year follow‐up (Abstract number 1). Neurourology & Urodynamics 2012;31(6):724‐5. [45454]
    1. Mostafa A, Swami S, Fielding S, N'Dow J, Abdel‐Fattah M. Exploring factors affecting women's decision to participate in randomised controlled trials assessing surgical treatment for stress urinary incontinence (Abstract number 359). Proceedings of the 41st Annual Meeting of the International Continence Society (ICS), 2011 Aug 29 to Sept 2, Glasgow, Scotland. 2011. [42217; NCT01230450]
Oliveira 2011 ARC SEC {published data only}
    1. Oliveira R, Botelho F, Silva P, Resende A, Silva C, Dinis P, et al. Exploratory study assessing efficacy and complications of TVT‐O, TVT‐Secur, and Mini‐Arc: results at 12‐month follow‐up. European Urology 2011;59(6):940‐4. [41493] - PubMed
    1. Santos Oliveira R, Botelho F, Silva P, Silva CMPM, Dinis P, Cruz FJMR. Randomized clinical trial comparing TVT‐O (trademark), TVT‐Secur (trademark) and Mini‐Arc (trademark). Outcome at 12 months follow‐up (Abstract 391). European Urology Supplements 2010;9(2):145. [41579]
Palomba 2012 AJS ARC SEC {published data only}
    1. Palomba S, Oppedisano R, Torella M, Falbo A, Maiorana A, Materazzo C, et al. A randomized controlled trial comparing three vaginal kits of single‐incision mini‐slings for stress urinary incontinence: surgical data. European Journal of Obstetrics Gynecology and Reproductive Biology 2012;163(1):108‐12. [44508] - PubMed
Pardo 2010 SEC ARC {published data only}
    1. Pardo J, Sola V, Ricci P. Effectiveness of TVT‐Secur compared with MiniArc for stress urinary incontinence: a randomized controlled trial with mini‐sling (Abstract number 221). Neurourology and Urodynamics 2010;29(6):1126‐7. [40161]
Schweitzer 2012 AJS {published data only}
    1. Schweitzer KJ, Cromheecke GJ, Milani AL, Eijndhoven HW, Gietelink D, Hallenleben E, et al. A randomised controlled trial comparing the TVT‐O® with the Ajust® as primary surgical treatment of female stress urinary incontinence. (Abstract number 32). International Urogynecology Journal 2012;23(Suppl 2):S77‐8. [45467]
Seo 2011 SEC {published data only}
    1. Seo JH, Kim GN, Kim JY, Seo HJ, Lee JW, Lee WG, et al. Comparison between transobturator vaginal tape inside out and single incision sling system in the treatment of female stress urinary incontinence: prospective randomized study (Abstract number 23). Neurourology and Urodynamics 2011;30(6):832. [42169]
Sivaslioglu 2012 TFS {published data only}
    1. Sivaslioglu AA, Unlubilgin E, Aydogmus S, Celen E, Dolen I. A prospective randomized comparison of transobturator tape and tissue fixation system minisling in 80 patient with stress urinary incontinence 5 year results. Journal of Urology 2012;188(1):194‐9. [43318] - PubMed
    1. Sivaslioglu AA, Unlubilgin E, Aydogmus S, Celen E, Dolen I. A prospective randomized comparison of transobturator tape and tissue fixation system minisling in 80 patient with stress urinary incontinence—3 year results. Pelviperineology 2010;29(2):56‐9. [43317]
    1. Sivaslioglu AA, Unlubilgin E, Dolen I, Kaplan M. The comparison of tissue fixation (TFS) system with transobturator tape (TOT) in the treatment of stress urinary incontinence (Abstract number 61). International Urogynecology Journal and Pelvic Floor Dysfunction 2007;18(Suppl 1):S36‐7. [27327]
Smith 2011 ARC {published data only}
    1. Smith AL, Castillo P, Karp D, Gross C, Davila G, Aguilar VC. Transobturator versus single incision slings in women with stress urinary incontinence: a prospective randomised controlled trial (Abstract presentation number 52). International Urogynecology Journal 2011;22 Suppl 1:S54‐5. [45303]
Sottner 2012 ARC AJS {published data only}
    1. Sottner O, Halaska M, Vlacil J, Maxova K, Mala I, Krombholz R, et al. [A comparison of different types of suburethral slings in the treatment of urinary incontinence in geriatric patients]. [Czech]. Ceska Gynekologie 2012;77(5):403‐7. [45893] - PubMed
Tommaselli 2010 SEC {published data only}
    1. Tommaselli GA, Carlo C, Gargano V, Formisano C, Scala M, Nappi C. Efficacy and safety of TVT‐O and TVT‐Secur in the treatment of female stress urinary incontinence: 1‐year follow‐up. International Urogynecology Journal 2010;21(10):1211‐7. [40921] - PubMed
Wang 2011 SEC {published data only}
    1. Wang YJ, Li FP, Wang Q, Yang S, Cai XG, Chen YH. Comparison of three mid‐urethral tension‐free tapes (TVT, TVT‐O, and TVT‐Secur) in the treatment of female stress urinary incontinence: 1‐year follow‐up. International Urogynecology Journal 2011;22(11):1369‐74. [42639] - PubMed
Yoon 2011 NDL {published data only}
    1. Yoon H, Lee DH, Kim YJ. Early results of comparison of Contasure‐needleless (trademark) and TOT outside‐in midurethral slings (Abstract number 852). Proceedings of the 41st Annual Meeting of the International Continence Society (ICS), 2011 Aug 29 to Sept 2, Glasgow, Scotland. 2011. [42238]

References to studies excluded from this review

Araco 2011 {published data only}
    1. Araco F, Gravante G, Sorge R, Overton J, Castri F, Primicerio M, et al. Sedation with local versus general anesthesia for the tension‐free vaginal tape Secur hammock procedure. International Journal of Gynaecology & Obstetrics 2011;113(2):108‐11. - PubMed
Choo 2011 {published data only}
    1. Choo M‐S, Lee K‐S, Lee HN, Lee YS, Seo JT. Clinical evaluation of the Needleless® Sling, 2011. www.ClinicalTrials.gov (accessed 1 March 2013). [42755]
de Leval 2011 {published data only}
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Diallo 2012 {published data only}
    1. Diallo S, Cour F, Josephson A, Vidart A, Botto H, Lebret T, et al. Evaluating single‐incision slings in female stress urinary incontinence: the usefulness of the CONSORT statement criteria. Urology 2012;80(3):535‐41. - PubMed
Martan 2008 {published data only}
    1. Martan A, Svabik K, Masata J, Koleska T, Haddad R, Pavlikova M. [The solution of stress urinary incontinence in women by the TVT‐S surgical method—correlation between the curative effect of this method and changes in ultrasound findings]. [Czech]. Ceska Gynekologie 2008;73(5):271‐7. [29223] - PubMed
Okulu 2011 {published data only}
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Porena 2012 {published data only}
    1. Porena M. Urinary incontinence and uro‐genital prolapse: a randomized trial of pelvic organ prolapse repair plus mini‐sling versus pelvic organ prolapse repair alone, 2012. www.ClinicalTrials.gov (accessed 1 March 2013). [SR‐INCONT45469]

References to studies awaiting assessment

Pushkar 2011 {published data only}
    1. Pushkar' DI, Kasian GR, Gvozdev MI, Lynova IL, Kupriianov IA. [Mini‐invasive operations for correction of urinary incontinence in females] [Russian]. Urologiia (Moscow, Russia) 2011, issue 4:16‐20. [SR‐INCONT43390] - PubMed

References to ongoing studies

Foote 2012 {published data only}
    1. Foote A. A randomised trial comparing two vaginal prolene sling surgeries for female urinary incontinence, 2012. www.anzctr.org (accessed 1 March 2013). [45458]
Maslow 2011 {published data only}
    1. Maslow KD. Trial comparing TVT SECUR system and transvaginal obturator tape for surgical management of stress urinary incontinence, 2011. www.ClinicalTrials.gov (accessed 1 March 2013). [SR‐INCONT42750]
Robert 2012 {published data only}
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Rosamilia 2012 {published data only}
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