Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation

Siegel, Steven; Noblett, Karen; Mangel, Jeffrey; Bennett, Jason; Griebling, Tomas L.; Sutherland, Suzette E.; Bird, Erin T.; Comiter, Craig V.; Culkin, Daniel J.; Zylstra, Samuel; Kan, Fangyu; Berg, Kellie Chase

doi:10.1016/j.juro.2017.07.010

Cited by 138 publications

(127 citation statements)

References 21 publications

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“…Another limitation is the absence of long‐term follow up. The InSite trial demonstrated sustained safety and effectiveness of SNM at both 3 and 5 year follow‐up . Hence longer follow up would be necessary to demonstrate additional potential benefit in this technique.…”

Section: Discussionmentioning

confidence: 99%

Outcomes in a contemporary cohort undergoing sacral neuromodulation using optimized lead placement technique

Adelstein

Lee

Gioia

et al. 2019

Neurourology and Urodynamics

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Aims To evaluate factors associated with progression to stage 2 sacral neuromodulation (SNM) for refractory overactive bladder, urinary retention, or fecal incontinence using optimal lead placement techniques with curved stylet. Methods This is a retrospective analysis of a prospectively collected database of all consecutive stage 1 SNM lead placements at our institution between August 2014 and May 2017 using optimal lead placement technique with curved stylet. Patients with refractory overactive bladder, urinary retention, or fecal incontinence were enrolled. Patients with 50% or more symptom improvement on voiding diaries were offered stage 2 implant. Demographics, clinical, and surgical characteristics were compared for patients who underwent successful stage 2 implants versus those who underwent lead removal at the end of the stage 1 trial period. Results 127 patients underwent SNM during the study period. Motor thresholds of ≤2 mA in all four electrodes were achieved in 74% of patients (94/127). A total of 89.0% (113/127) of patients received stage 2 implants. The main indication for implant, specifically urgency urinary incontinence, was positively associated with progression to stage 2 implant. Male gender, history of pelvic pain and previous SNM were negatively associated with progression to stage 2 implant. Conclusions Our findings demonstrate that the contemporary optimized lead placement technique resulted in low motor thresholds and successful progression to stage 2 SNM implant in the majority of our cohort. Predictive factors associated with success or failure may potentially guide decision making for therapeutic interventions and counseling patient expectations.

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Section: Discussionmentioning

confidence: 99%

Outcomes in a contemporary cohort undergoing sacral neuromodulation using optimized lead placement technique

Adelstein

Lee

Gioia

et al. 2019

Neurourology and Urodynamics

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“…The most common reasons for (re)programming are lack or loss of efficacy and undesirable stimulation. If (re)programming does not alleviate the patient's symptoms, surgical revision is needed, which is reported to occur in 32‐38% by prospective long‐term multicenter studies …”

Section: Discussionmentioning

confidence: 99%

Repeatability of tools to assist in the follow up and troubleshooting of sacral neuromodulation patients using the sensory response

Vaganée¹,

Borne²,

Fransén

et al. 2019

Neurourology and Urodynamics

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Purpose Sacral neuromodulation (SNM) is an established minimally invasive therapy for functional disorders of the pelvic organs in which electrodes are stimulated in proximity of the sacral spinal nerves. Reprogramming of the electrodes is regularly required and is based on the sensory response. This study assesses the repeatability of a pelvic chart and grading system to enable a more objective assessment of the sensory response upon electrode stimulation. Material and Methods In 26 SNM patients, with OAB or NOUR, assessment of the sensory response was done using the sensory threshold (ST) and a pelvic chart with 1 cm2 coordinates, each coordinate corresponding with a dermatome and location of sensation (LoS). A grading system was developed based upon the ST and LoS. Repeatability of ST was assessed using a two‐way mixed effects, absolute agreement, single rater/measurement intraclass correlation coefficient (ICC), and displayed using a correlation and Bland Altman plot. Repeatability of dermatomes, LoS, and grading system was assessed using kappa correlation coefficient. Results On average, 1.55 ± 0.85 coordinates were used to point out the area where the stimulation was perceived. The mean amount of coordinates between the area pointed at during the first and second measurement was 0.47 ± 0.74. ST showed excellent repeatability (ICC 0.93, 95%CI 0.90‐0.94, P < 0.001). Dermatomes, LoS and grading system showed a substantial to almost perfect agreement (κ = 0.740‐0.833, P < 0.001). Conclusions The pelvic chart and grading system, using the sensory response upon electrode stimulation, are repeatable tools and can be used to assist in follow up and troubleshooting of SNM patients.

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“…[2][3][4] New rechargeable SNM systems may provide the ability to program patients, including utilizing higher power settings, without the need to maximize battery life associated with non-rechargeable SNM systems, which can require sacrificing efficacy to extend battery life or increasing programming visits to try advanced programming options (eg, cycling stimulation). This study provides evidence that subjects, particularly those experiencing therapeutic benefit, are satisfied with rechargeable sacral neuromodulation and recharging is neither a barrier for use nor an unwanted burden.…”

Section: Discussionmentioning

confidence: 99%

“…Studies have shown that the improved technology and techniques have increased therapy efficacy and decreased surgical revision and explant rates. [2][3][4] Despite the improvements in some aspects of SNM, the therapy has lacked the technological innovation seen in other areas of neuromodulation, namely spinal cord stimulation (SCS) and deep brain stimulation (DBS). Rechargeable neuromodulation systems lasting 10 or more years in the body were introduced for SCS in 2006, 5 but were not available for SNM until recently.…”

Section: Introductionmentioning

confidence: 99%

Programming settings and recharge interval in a prospective study of a rechargeable sacral neuromodulation system for the treatment of overactive bladder

Kerrebroeck¹,

Wachter²,

Ruffion³

et al. 2018

European Urology Supplements

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Aims:The RELAX-OAB study is designed to confirm the safety, efficacy, and technical performance of the Axonics r-SNM System, a miniaturized, rechargeable SNM system approved in Europe and Canada for the treatment of bladder and bowel dysfunction. The purpose of this article is to describe study subjects' ability to charge the rechargeable neurostimulator and to document their neurostimulator program settings and recharge interval over time. Methods: Fifty-one OAB patients were implanted in a single-stage procedure.These results represent the 3-month charging experience for 48 subjects who completed the 3-month follow-up. Recharge intervals were estimated using therapy stimulation settings and subject experience was evaluated using questionnaires. Results: Forty-seven of forty-eight (98%) subjects were able to successfully charge their device prior to follow-up within 1-month post-implant. At 3-month post-implant, 98% of subjects were able to charge prior to their follow-up visit.Average stimulation amplitude across all subjects was 1.8 mA (±1.1 mA). A total of 69% of subjects had ≥14-day recharge intervals (time between charging) and 98% of subjects had ≥7-day recharge interval. No charging related adverse events occurred. Conclusions: Study subjects were able to charge the Axonics r-SNM System and stimulation settings provided 2 weeks of therapy between recharging for most subjects. Subject satisfaction indicates that subjects are satisfied with rechargeable SNM therapy. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation

Abstract: 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.

Cited by 138 publications

References 21 publications

Outcomes in a contemporary cohort undergoing sacral neuromodulation using optimized lead placement technique

Outcomes in a contemporary cohort undergoing sacral neuromodulation using optimized lead placement technique

Repeatability of tools to assist in the follow up and troubleshooting of sacral neuromodulation patients using the sensory response

Programming settings and recharge interval in a prospective study of a rechargeable sacral neuromodulation system for the treatment of overactive bladder

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