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

• Published in: Neurourology and urodynamics Vol. 35; no. 2; pp. 246 - 251
• Main Authors: Noblett, Karen, Siegel, Steven, Mangel, Jeffrey, Griebling, Tomas L., Sutherland, Suzette E., Bird, Erin T., Comiter, Craig, Culkin, Daniel, Bennett, Jason, Zylstra, Samuel, Kan, Fangyu, Berg, Kellie Chase
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.02.2016
• Subjects: Adult; Aged; Female; Humans; Male; Middle Aged; Neural Prostheses; overactive bladder; Prospective Studies; Quality of Life; Recovery of Function; sacral neuromodulation; Sacrum; Spinal Cord Stimulation - adverse effects; Spinal Cord Stimulation - instrumentation; Spinal Cord Stimulation - methods; Surveys and Questionnaires; Time Factors; Treatment Outcome; urgency frequency; Urinary Bladder - innervation; Urinary Bladder, Overactive - diagnosis; Urinary Bladder, Overactive - physiopathology; Urinary Bladder, Overactive - psychology; Urinary Bladder, Overactive - therapy; urinary incontinence; Urinary Incontinence, Urge - diagnosis; Urinary Incontinence, Urge - physiopathology; Urinary Incontinence, Urge - psychology; Urinary Incontinence, Urge - therapy; Urodynamics; quality of life; urgency frequency; overactive bladder; urinary incontinence; sacral neuromodulation
• ISSN: 0733-2467; 1520-6777; 1520-6777
• DOI: 10.1002/nau.22707

Aims This prospective, multicenter post‐approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim® 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 ± 2.7 leaks/day, UF subjects had 12.6 ± 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 ± 2.7 leaks/day; UF subjects had a mean reduction of 5.1 ± 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. © 2014 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.