Case Study: Surgery for Urinary Incontinence
| At a Glance |
Research Question
What is the comparative effectiveness of two common mid-urethral sling procedures for stress urinary incontinence (SUI)?
NERI's Role
The trial was conducted by the Urinary Incontinence Treatment Network for which NERI has been the Data Coordinating Center for the past 10 years.
Results
The Trial of Mid-Urethral Slings found that the two most common mid-urethral sling procedures are similar in their chance of cure, though each surgery has different risks.
Funding Institution
This study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Child Health and Human Development.
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Roughly half of all women experience urinary incontinence at some point in their lives. This involuntary loss of urine is not just embarrassing--left untreated it can have profound social and economic impacts.
NERI clinical researchers took part in the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr), which compared the efficacy of two gold-standard surgeries: the fascial pubovaginal sling; and the Burch colposuspension. These surgeries have been performed for many years with good results but have never been compared in a randomized trial.
NERI's Role
655 women with predominant stress urinary incontinence were randomized to one of the surgeries, which were conducted at nine clinical centers in the US. The SISTEr trial included robust 24-month follow-up using standardized definitions, procedures and methods of evaluation to assess a variety of outcome measures and comprehensive post-operative morbidity.
Results
The sling procedure had significantly higher success rates at 24 months than the Burch procedure. Although about half of these women had additional surgeries to repair pelvic organ prolapse, the results were not modified by performance of these concomitant procedures. The higher success rates in the sling group, however, were offset somewhat by higher rates of side effects such as urinary tract infection and voiding dysfunction after surgery. Nonetheless, the results provide critical guidance to clinicians and underscore the need for even better surgical and pharmacological treatment options for this condition.