Florida Bladder Institute involved in International Study

10/28/2013

Study closed to new participants 12/01/14

A new post-market study sponsored by Boston Scientific Corp. began at the Florida Bladder Institute in August 2013.  This FDA approved study will be conducted at many study centers throughout the United States and Australia.  Dr Joseph Gauta, Board Certified in Female Pelvic Medicine & Reconstructive Surgery, is Principal Investigator at the Florida Bladder Institute. The study titled “A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of the Solyx ‘Single Incision Sling’ (SIS) System vs. the Obtryx II Sling System for the Treatment of Women with Stress Urinary Incontinence” will determine the long-term effectiveness and safety of a minimally invasive mid- urethral sling system for the treatment of stress urinary incontinence (SUI).


The prevalence of urinary incontinence in adult women is estimated at 4%-35%. It is considered severe in about 3%-17% of adult women. Urinary incontinence is considered a “potentially debilitating social problem which leads to high health care costs.” The most common surgery for stress urinary incontinence (SUI) is the minimally invasive sling surgery which has replaced the Burch colposuspension as gold standard treatment for female urinary stress incontinence. Incontinence surgery has become a routine part of urologic care but often can be difficult to manage complications and recurrent incontinence.


Mid-urethral slings have been reported in published literature to be highly efficacious in managing SUI in women. The transobturator placement was developed to decrease morbidity, but has been noted to be associated with a higher incidence of thigh pain than the retropubic approach. Single incision slings were developed to offer the benefits of the transobturator approach in addition to a minimally invasive approach through a single 1.5 cm incision to the vagina and without exiting the skin. In six recent publications comparing transobturator slings and single incision slings for SUI, cure rates were similar ranging from 81.6%-96.4% for transobturator and 67%-87% for single incision.

One publication noted similar rates of complications, three publications noted higher complication rates for the transobturator approach compared to the single incision approach, and two publications demonstrated higher complication rates for the single incision approach when compared to the transobturator approach. All of the above mentioned published data on transobturator and single incision slings for SUI are specific to use of TVT-T Secur, MiniArc and Monarc devices with no such comparative published reports specific to use of the Solyx and/or Obtryx slings. To date, the only published data on the Obtryx sling is from a randomized controlled study of Obtryx and Advantage Transvaginal Midurethral Sling with 81% of Obtryx patients reporting cure at 12 months as compared to 77% Advantage patients.


The Solyx sling is an FDA 510(k) cleared mesh implant intended for use as a suburethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Two studies have reported cure rates for the Solyx sling, including a retrospective, multi-center study with 95% of patients reporting objective and subjective success at a mean of 6.5 months, and a prospective, short-term, multi-center trial with objective cure rates of 94.7% at 12 weeks. Both studies reported no unexpected safety events.  Data from these two studies support the short-term objective success and safety profile of the Solyx Sling yet do not provide evidence of the long-term comparison to traditional mid-urethral slings.


In 2011, the FDA updated a previously published safety communication to alert health care providers and patients of the complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. FDA convened a panel of experts who determined that long-term studies would be beneficial in the understanding of patient outcomes and complications from products used to treat pelvic organ prolapse and stress urinary incontinence. The type of slings FDA focused on for these additional data only include the “single-incision sling”, such as Solyx. Study enrollment began in August 2013 and participants will be followed for three years after their surgery.

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