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Pdf Summary
The InSite study evaluated the therapeutic outcomes of sacral neuromodulation (SNM) with the InterStim system for overactive bladder (OAB) in both females and males. The study found no significant difference in rates of adverse events between the two genders. The results showed that SNM with the InterStim system is an effective long-term treatment option for OAB for both males and females, with positive treatment outcomes and no difference in safety.<br /><br />The baseline demographics of the subjects included in the study showed that the majority were female (91%) and white (89%). The mean age at implant was 57 years and the mean duration of diagnosis at implant was 8 years. The study also evaluated the OAB qualification per diary, baseline leaks per day, baseline voids per day, and OAB medications tried prior to implant.<br /><br />The therapeutic success rate of SNM therapy was not different between females and males at any of the annual visits. Quality of life, as measured by the ICIQ-OABqol questionnaire, improved for both females and males at follow-up visits from baseline. However, females had a significantly greater improvement in HRQL score than males at certain time points.<br /><br />Overall, the study concluded that SNM with the InterStim system is an effective and safe treatment option for OAB in both females and males. However, further research is needed to validate these results, particularly in relation to males, due to the small number of male subjects included in the analyses. The study was sponsored by Medtronic.
Keywords
InSite study
sacral neuromodulation
InterStim system
overactive bladder
therapeutic outcomes
adverse events
long-term treatment option
baseline demographics
OAB qualification per diary
baseline leaks per day
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