Abstract
Objectives: The Solyx System was developed to be easier and safer to use than other slings. It was the objective of this study to retrospectively assess the long-term safety and efficacy of the SolyxTM SIS Sling System. Methods: After IRB approval and informed consent, chart reviews with follow up phone questionnaires of 69 subjects implanted with the Solyx Sling were collected at 2 sites. All of the patients had SUI and had urethral hypermobility with a q-tip test of >30 degrees. All subjects underwent surgery from 12/2008 to 01/2010 with a mean follow up of 43 months (range 39 -49). Subjects included in this data collection had a mean age of 67 years (range 30 -87). The dominant type of incontinence within the study patients was SUI while 17/69 (25%) of the subjects also had a component of urge incontinence. 38/69 (55%) of study patients had concomitant procedures. Results: Long-term Solyx results showed 64/69 (93%) of patients were subjectively dry by questionnaire and were satisfied with their outcome. 63/69 (91%) would have the procedure again. There were 4 cases of denovo urge incontinence and 2 reports of transient retention. There were no serious adverse events including no bladder, bowel, vessel or nerve perforations and no erosions or extrusions. No pain was reported that was attributed to the implant. Conclusions: Chart review with follow phone questionnaires indicated that the Solyx Sling was a safe, efficacious and less-invasive option for patients requiring SUI surgery and that these results were sustainable for an average of 43 months.
Highlights
The treatment of Stress Urinary Incontinence (SUI) has changed dramatically as a result of the contributions of Ulmsten and Petros
Sixty-nine subjects meeting all of the inclusion/exclusion criteria and who underwent surgery with the SolyxTM single incision sling (SIS) System [Figure 1] for treatment of stress urinary incontinence were enrolled in the clinical trial
All patients were diagnosed with stress urinary incontinence
Summary
The treatment of Stress Urinary Incontinence (SUI) has changed dramatically as a result of the contributions of Ulmsten and Petros. They demonstrated to the urogynecology and urology communities that one could correct SUI by using a piece of polypropylene mesh anchored via the retropubic space [1]. Retropubic correction of SUI with a TVT does have inherent risks such as bowel, vascular, and bladder injury [2,3]. These complications are due to the blind passage of trocars through the retropubic space. More recent retrospective and prospective studies on the use of second generation single incision sling systems have demonstrated minimal morbidity and relatively high
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