Sacral Neuromodulation: Determining Predictors of Success.

OBJECTIVE: To determine predictors of success for sacral neuromodulation in women with overactive bladder, urinary retention, and fecal incontinence. METHODS: A retrospective chart review was performed on women who underwent a staged sacral neuromodulation implantation between 2007 and 2018. Clinical and procedural characteristics were recorded. Presence of intraoperative motor responses in either all 4 or <4 electrodes were used to group women. Endpoints included completion of stage II implant, tined lead revision, and patient-reported success. RESULTS: In 198 women with a mean age of 62.9 years (SD+/- 14.7), completion of stage II implant occurred in 92.4% of women, and 83.3% of these women reported success at the first postoperative visit. Continued success at 6 months was reported in 70.3%. Lead revision was noted in 23.0%. Age >65 years (odds ratio [OR] = 0.2, 95% confidence interval [CI] = 0.06-0.8) and prior onabotulinumtoxinA (onaBoNT-A) (OR = 0.2, 95% CI = 0.06-0.9) were negative predictors for completion of stage II implant on multivariable analysis. Also, prior pelvic floor physical therapy was a significant negative predictor of postoperative patient-reported success on multivariable analysis (OR = 0.25, 95% CI = 0.1-0.6). There were no differences seen in women who had motor responses with either all 4 electrodes or <4 electrodes in any endpoint (P > .05). CONCLUSION: Patient age >65 and history of prior onaBoNT-A were associated with failure to complete stage II implant. Women with prior pelvic floor physical therapy were less likely to report success after sacral neuromodulation. Motor responses in <4 electrodes during lead testing did not impact patient-reported success.

Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.

PURPOSE: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence. MATERIALS AND METHODS: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years. CONCLUSIONS: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.

Transcutaneous Electrical Nerve Stimulation of the Foot: Results of a Novel At-home, Noninvasive Treatment for Nocturnal Enuresis in Children.

OBJECTIVE: To evaluate the effect of a novel at-home approach to electrical foot stimulation of peripheral tibial nerve branches on the frequency of nocturnal enuresis episodes in children. MATERIALS AND METHODS: Children aged 5 to 18 having 2 or more bedwetting episodes per week for at least 3 consecutive months were eligible. The study was a total of 6 weeks. Participants completed a baseline nighttime voiding diary during the first 2 weeks. This was followed by 2 weeks of foot stimulation for 60 minutes each night. During the stimulation period, and the following 2 weeks poststimulation, participants completed the nighttime voiding diary. RESULTS: Twenty-two patients with a mean age of 11.4 years (range 7-16) completed the study. Overall, there was a significant reduction in mean total wet nights from 9.0 ± 4.0 to 6.8 ± 4.8 during the stimulation period (P < .01) and a sustained significant reduction to 7.2 ± 5.0 wet nights during the poststimulation period (P = .02). Sixteen patients (72.7%) showed improvement of at least 1 less wet night during stimulation, demonstrating a significant improvement from a mean of 7.9 ± 3.7 to 4.8 ± 3.5 wet nights during the 2-week stimulation (P < .01) and maintained an improved mean of 5.1 ± 4.0 wet nights during the poststimulation period (P < .01). There were no adverse events experienced by any child. CONCLUSION: Transcutaneous foot stimulation is a well-tolerated, noninvasive, at-home treatment that may reduce the number of wet nights in children with nocturnal enuresis.

Magnetic resonance imaging following InterStim®: an institutional experience with imaging safety and patient satisfaction.

AIMS: We retrospectively assessed patient safety and satisfaction after magnetic resonance imaging (MRI) in patients with an InterStim® unit. METHODS: The records of all patients implanted with InterStim® between 1998 and 2006 were reviewed. Nine of these patients underwent MRI following InterStim® implantation. The patients' neurologists requested the MRI exams for medical reasons. Both 0.6 Tesla (T) and 1.5 T machines were used. Patient safety, interference of implanted pulse generator (IPG) with radiological interpretation, and patient satisfaction were assessed in these patients. RESULTS: The first patient in the series had IPG failure following MRI. For this patient, the voltage amplitude was set to zero, the IPG was turned off, and the IPG magnetic switch was left on. The patient underwent MRI uneventfully; however, the IPG did not function upon reprogramming. The IPG magnetic switch was turned off for the eight subsequent patients, all of whom underwent MRI safely. In addition, all of their IPGs functioned appropriately following reprogramming. Of the 15 MRIs performed, the lumbar spine was imaged in eight studies, the pelvis was imaged in one study, and the remaining examinations involved imaging the brain or cervical spine. Neither the IPG nor the sacral leads interfered with MRI interpretation. None of the eight patients perceived a change in perception or satisfaction following MRI. CONCLUSIONS: Although we don't advocate the routine use of MRI following InterStim® implantation, our experience suggests MRI may be feasible under controlled conditions and without adverse events.