Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder

Abstract

Aims: This prospective, multicenter post-approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim 1 System at 12-months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency-frequency (UF), who failed at least one anticholinergic medication and had at least one not tried were included. Methods: Subjects with successful test stimulation received an SNM implant. Therapeutic success (!50% improvement in average leaks/day or voids/day or a return to normal voiding frequency [<8 voids/day]) and quality of life through 12 months were evaluated for implanted subjects. Results: Of the 340 subjects that went through test stimulation, 272 were implanted with SNM. Of these, 91% were female, mean age was 57, UI subjects had 3.1 AE 2.7 leaks/day, UF subjects had 12.6 AE 4.5 voids/day. The analysis which includes all implanted subjects with diary data at baseline and 12 months showed an OAB therapeutic success rate of 85% at 12 months. UI subjects had a mean reduction of 2.2 AE 2.7 leaks/day; UF subjects had a mean reduction of 5.1 AE 4.1 voids/day (both P < 0.0001). Subjects showed significant improvement from baseline in all measures of ICIQ-OABqol (all P < 0.0001). 80% of subjects reported improved changes in their urinary symptom interference at 12 months. Device-related adverse events occurred in 16% (56/340) of subjects during test stimulation and 30% (82/272) of subjects post-implant. Conclusions: This multicenter study shows SNM is safe and effective and results in improved outcomes through 12 months in subjects with OAB symptoms, without requiring failure of all medications. Neurourol. Urodynam. 35:246-251, 2016.

A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12‐month results from the RELAX‐OAB study

“…The RELAX‐OAB study was a prospective, multi‐center study evaluating the safety and efficacy on the Axonics r‐SNM System, the first rechargeable sacral neuromodulation device with regulatory approval in Europe, Canada, and Australia. The 1‐year data from this study demonstrates positive results in safety and efficacy similar to that in the literature for non‐rechargeable SNM …”

“…The cohort of subjects in this clinical study were a moderately to severely affected group with an average of 14.7 voids per day and 9.6 daily incontinence episodes. These baseline symptoms are much more severe than recent trials where the average urgency incontinence episodes ranged from 3.1‐5.2 per day . The dramatic reduction in symptoms seen at 3‐months in the RELAX‐OAB study has been maintained out to 1‐year with 94% of test responders having continued therapy success, and all subjects maintaining a 72% success rate.…”

“…SNM received CE mark approval for treatment of bladder and bowel dysfunction in 1994 and U.S. Food and Drug Administration (FDA) approval in 1997 for urinary urgency incontinence with subsequent approvals for urinary frequency, non‐obstructive urinary retention and fecal incontinence. As of 2015, SNM has been used to treat over 250 000 patients with refractory pelvic floor dysfunction …”

New developments in therapies for fecal incontinence

“…Sacral nerve stimulation (SNS) (InterStim, Medtronic, Minneapolis, Minnesota, USA) has been used to treat urologic conditions (overactive bladder and nonobstructive urinary retention) in the United States since 1997 [10,11]. Although initial studies on the use of SNS for fecal incontinence were published in 1995, this therapy did not receive FDA approval for this indication until 2011.…”

Sacral Neuromodulation in Urological Practice

“…Recent studies have shown the rate of removal due to infection is 3%. 44 Re-operation for lack of efficacy over time, uncomfortable stimulation, and pain at the generator site are all potentially necessary if the problems cannot be improved by reprogramming. Frequent reprogramming may be required for some patients, …”