Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation
Abstract
Purpose:
We evaluated the therapeutic success rate, changes in quality of life and safety of sacral neuromodulation 5 years after InterStim™ implantation. Included in study were subjects with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency-frequency, in whom at least 1 anticholinergic medication failed and 1 medication had not been tried.
Materials and Methods:
Therapeutic success was defined as a urinary urge incontinence or urgency-frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day. Quality of life was evaluated by ICIQ-OABqol (International Consultation on Incontinence Modular Questionnaire). Safety was evaluated through adverse events.
Results:
Of the 340 subjects who completed the test stimulation 272 had an implant, of whom 91% were female. Mean age was 57 years. At baseline 202 subjects with urinary urge incontinence had a mean ± SD of 3.1 ± 2.7 leaks per day and 189 with urgency-frequency had a mean of 12.6 ± 4.5 voids per day. The 5-year therapeutic success rate was 67% (95% CI 60–74) using modified completers analysis and 82% (95% CI 76–88) using completers analysis. Subjects with urinary urge incontinence had a mean reduction from baseline of 2.0 ± 2.2 leaks per day and subjects with urgency-frequency had a mean reduction of 5.4 ± 4.3 voids per day (each completers analysis p <0.0001). Subjects showed improvement in all ICIQ-OABqol measures (p <0.0001). The most common device related adverse events were an undesirable change in stimulation in 60 of the 272 subjects (22%), implant site pain in 40 (15%) and therapeutic product ineffectiveness in 36 (13%).
Conclusions:
This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.
References
- 1 : The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study. BJU Int2009; 104: 352. Google Scholar
- 2 : Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol2015; 193: 1572. Link, Google Scholar
- 3 : The management of overactive bladder syndrome: a review of the European Association of Urology Guidelines. Clin Pract2013; 10: 593. Google Scholar
- 4 : Long-term outcome of the use of intravesical botulinum toxin for the treatment of overactive bladder (OAB). BJU Int2013; 111: 106. Google Scholar
- 5 : Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study. J Urol2013; 189: 2194. Link, Google Scholar
- 6 : Five-year follow-up after sacral neuromodulation: single center experience. Neuromodulation2007; 10: 363. Google Scholar
- 7 : Long-term follow-up of sacral neuromodulation for lower urinary tract dysfunction. BJU Int2014; 113: 789. Google Scholar
- 8 : Neuromodulation for overactive bladder symptoms in women utilizing either motor or sensory/motor provocation with a minimum nine-year follow-up. Neuromodulation2015; 18: 517. Google Scholar
- 9 : Sacral neuromodulation for refractory lower urinary tract dysfunction: results of a nationwide registry in Switzerland. Eur Urol2007; 51: 1357. Google Scholar
- 10 : Sacral nerve stimulation for voiding dysfunction: one institution’s 11-year experience. Neurourol Urodyn2007; 26: 19. Google Scholar
- 11 : Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn2015; 34: 224. Google Scholar
- 12 : Three-year follow-up results of a prospective, multicenter study in overactive bladder subjects treated with sacral neuromodulation. Urology2016; 94: 57. Google Scholar
- 13 : 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. Neurourol Urodyn2016; 35: 246. Google Scholar
- 14 : Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res2002; 11: 563. Google Scholar
- 15 : Sexual dysfunction in men with lower urinary tract symptoms. J Clin Epidemiol1998; 51: 677. Google Scholar
- 16 : The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol1996; 77: 805. Google Scholar
- 17 : Manual for the Beck Depression Inventory II. San Antonio, Texas: The Psychological Corp1996. Google Scholar
- 18 : OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: a randomized clinical trial. JAMA2016; 316: 1366. Google Scholar
- 19 Noblett K, Berg KC, Kan F et al: Baseline symptom severity and therapeutic success in a large prospective trial of sacral neuromodulation therapy for overactive bladder patients. Unpublished data. Google Scholar
- 20 : Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol2007; 178: 2029. Link, Google Scholar
- 21 : Detailed analysis of adverse events and surgical interventions in a large prospective trial of sacral neuromodulation therapy for overactive bladder patients. Neurourol Urodyn2017; 36: 1136. Google Scholar
- 22 : Sacral neuromodulation and botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System. World J Urol2015; 33: 1109. Google Scholar
- 23 : Economic evaluation of sacral neuromodulation in overactive bladder: a Canadian perspective. Can Urol Assoc J2015; 9: 242. Google Scholar
