Position Statement on Mid-Urethral Slings for Stress Urinary Incontinence

IUGA 2014 supports the use of monofilament polypropylene mid-urethral slings for the surgical treatment of female stress urinary incontinence. The International Urogynecological Association recently released a position statement on the use of mid-urethral slings for stress urinary incontinence, which can be found below and also downloaded as a PDF file here.

Position Statement on Mid-Urethral Slings for Stress Urinary Incontinence

The International Urogynecological Association (IUGA) supports the use of mid-urethral slings (MUS) as one of the options for the surgical management of female stress urinary incontinence (SUI) which is the type of urinary leakage associated with physical exertion and coughing, laughing, exercise.

Stress urinary incontinence is a common1, burdensome and costly condition for women with a negative impact on quality of life. Non-surgical measures such as pelvic floor muscle training (PFMT) are useful treatment options in alleviating symptoms although many women proceed with surgery if these are not successful.

Surgery is generally a more effective treatment for severe SUI than PFMT.2

Mid-urethral slings are minimally invasive procedures developed in Europe in the 1990s to treat female stress urinary incontinence. These slings are narrow, synthetic polypropylene tapes that are surgically placed beneath the middle part of the urethra (water pipe) to provide dynamic support to stop leakage from the bladder. They have been shown to be as effective as more invasive traditional surgery with major advantages of shorter operating and admission times, and a quicker return to normal activities together with lower rates of complications.3 This has resulted in MUS becoming the operation of choice in Europe, Asia, South America, South Africa, Australasia4 and North America5 for treatment of SUI with several million procedures performed worldwide.

The US Food and Drug Administration (FDA) in the USA released a white paper6 and safety communications7 regarding safety and effectiveness of transvaginal placement of surgical mesh specifically for pelvic organ prolapse. This is a condition in which some of the pelvic organs bulge downwards giving rise to symptoms. Media attention8 on this totally distinct and separate issue of mesh use in women has the potential to cause unnecessary confusion and fear in women considering MUS for treatment of stress urinary incontinence. The FDA publications clearly state that MUS (both retropubic and transobturator slings) were not the subject of their safety communication but further follow-up studies were required for single incision slings.

There is robust evidence9-11 to support the use of MUS from over 2,000 publications making this treatment the most extensively reviewed and evaluated procedure for female stress urinary incontinence now in use. These scientific publications studied all types of patients, including those with co-morbidities such as prolapse, obesity and other types of bladder dysfunction. It is, however, acknowledged that any operation can cause complications. For MUS these include bleeding, damage to the bladder and bowel, voiding difficulty, tape exposure and pelvic pain; all of these may require repeat surgery but this is uncommon.12 Nevertheless, the results of a recent large multi-centre trial13 have  confirmed excellent outcomes and a low rate of complications to be expected after treatment with MUS. Additionally, long term effectiveness  of up to 80% has been demonstrated in studies including one which has followed up a small group of patients for 17 years.14-15

As a result, IUGA supports the use of monofilament polypropylene mid-urethral slings for the surgical treatment of female stress urinary incontinence.

References

1. http://www.aihw.gov.au/publication-detail/?id=60129543605[accessed 23Feb14]

2. Labrie J, Berghmanns BL, Fischer K et al, Surgery versus physiotherapy for stress urinary incontinence. N Engl J Med, 2013. 369(12): p. 1124-33. doi: 10.1056/NEJMoa1210627. PMID 24047061

3. Cody J, Wyness L, Wallace S et al. Systematic review of the clinical effectiveness and cost-effectiveness of tension-free vaginal tape for treatment of urinary stress incontinence. Health Technol Assess 2003; 7 (21): iii, 1–189.

4. Lee J, Dwyer PL. Age related trends in female Stress Urinary Incontinence Surgery in Australia – Medicare data 94 – 09. Aust N Z J Obstet Gynaecol 2010; 50: 543 – 549. doi:10.1111/j.1479-828X.2010.01217.x PMID:21133865

5. http://www.augs.org/d/do/2535 [accessed 25feb14]

6. FDA, Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal Placement for Pelvic Organ Prolapse. 2011: http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/UCM262760.pdf

7. FDA, FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. 2011.

8. http://www.bjuinternational.com/bjui-blog/midurethral-tape-surgery-for-incontinence-a-possible-victim-of-the-vaginal-mesh-crisis/ [accessed 23Feb14]

9. Ogah J, Cody JD, & Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst. Rev. CD006375 (2009).

10. Rehman H, Bezerra CC, Bruschini H, Cody JD. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst. Rev. CD001754 (2011).

11. Novara, G., et al., Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol, 2010. 58(2): p. 218-38.

12. http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice%E2%80%93M%E2%80%93T/Syntheticvaginaltapesforstressincontinence/Summariesofthesafetyadverseeffectsofvaginaltapesslingsmeshesforstressurinaryincontinence/index.htm [accessed 25Feb14]

13. Richter H E et al. Retropubic versus transobturator midurethral slings for stress incontinence. N. Engl. J. Med. 362, 2066–2076 (2010).

14. Nilsson CG, et al., Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J, 2013. 24(8): p. 1265-9.

15. Liapis A, Bakas P, Creatsas G. Long-term efficacy of tension-free vaginal tape in the management of stress urinary incontinence in women: efficacy at 5- and 7-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct 2008; 19:150