Real-world data support the efficacy, safety, and quality of life improvement of sacral neuromodulation for lower urinary tract dysfunctions.
In the prospective SOUNDS (Sacral neuromOdUlation with InterStim™ therapy for intractable lower uriNary tract DySfunctions) study, 247 of 320 patients with overactive bladder (OAB) or unobstructed urinary retention received a permanent implant or replacement neurostimulator and/or lead.
Over 10 months, voids in patients with urinary frequency significantly declined from baseline among those with de novo implants (from 12.7 to 8.6 voids per day) and those with replacement implants (from 11.5 to 7.9 voids per day), Emmanuel Chartier-Kastler, MD, of Sorbonne University, Hôpitaux Universitaires Pitié-Salpétrière in Paris, France, and colleagues reported in European Urology Focus. Leaks in patients with urge urinary incontinence (UUI) also significantly declined among those with de novo implants (from 4.3 to 1.1 leaks per day) and those with replacement implants (from 5.4 to 1.0 leaks per day). Complete continence was achieved by 46% of the de novo group and 53% of the replacement group over 10 months.
Quality of life measures, including disease bother, urinary symptom profile score, and Ditrovie questionnaire score, also significantly improved.
With respect to adverse events, 20% of patients required a revision within 2 years, including 9% who had permanent explantation.
“This large, observational study confirmed that [sacral neuromodulation] confers significant symptom and QoL improvements in OAB patients routinely treated in the French health-care setting that are similar in magnitude to what has been previously published,” Dr Chartier-Kastler’s team concluded.
Disclosure: This research was supported by Medtronic. Please see the original reference for a full list of disclosures.
Chartier-Kastler E, Le Normand L, Ruffion A, et al. Sacral neuromodulation with the InterStim™ system for intractable lower urinary tract dysfunctions (SOUNDS): results of clinical effectiveness, quality of life, patient-reported outcomes and safety in a French multicenter observational study. Eur Urol Focus. Published online September 6, 2020. doi:10.1016/j.euf.2020.06.026