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.