Two‐year safety and efficacy outcomes for the treatment of overactive bladder using a long‐lived rechargeable sacral neuromodulation system

Blok, Bertil; Kerrebroeck, Philip Van; Wachter, S. De; Ruffion, A.; Aa, Frank Van der; Perrouin-Verbe, M.-A.; Elneil, Sohier

doi:10.1002/nau.24317

Cited by 16 publications

(4 citation statements)

References 21 publications

(29 reference statements)

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“…This analysis confirmed the effective and stable performance of both systems. The improvements in voiding diaries and subjective scores observed in both group patients are comparable to those previously reported in patients using other types of SNM devices 13 . Comparing the two systems directly, we found that there were slight differences concerning improvements in daily urination and urine leakage times.…”

Section: Discussionsupporting

confidence: 86%

Sacral neuromodulation for overactive bladder using the InterStim and BetterStim systems

Meng

Tian

Zhang

et al. 2022

Sci Rep

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This study aimed to evaluate differences in the clinical outcomes of different sacral neuromodulation systems (InterStim and BetterStim) used in the treatment of overactive bladder. Data from a previously established database of sacral neuromodulation in China (the InterStim system) and a 2020 clinical trial of the BetterStim system were screened. Patients with overactive bladder undergoing stage II implanted pulse generator implantation were selected for analysis and divided into InterStim and BetterStim system groups. Voiding diaries and subjective scores obtained preoperatively, after stage I tined-lead implantation (experience period), and after stage II implanted pulse generator implantation were compared between the two groups. This study included 113 patients with overactive bladder (43, InterStim system group; 70, BetterStim system group). Voiding diaries and subjective scores significantly improved in both the InterStim and BetterStim system groups over the treatment period. Specifically, the urination frequency (all P < 0.001), average voiding volume (all P < 0.001), and average urinary leakage (InterStim, P < 0.05; BetterStim, P < 0.01) in both groups significantly improved at different periods during treatment. At the same time, the urgency perception scale (P < 0.001) and OAB-related quality of life score (InterStim, P < 0.05; BetterStim, P < 0.01) also significantly improved. There was no significant difference in urination frequency at baseline between the two groups (P = 0.169). Urination frequency was significantly higher in the BetterStim system group than in the InterStim group during the experience period and at follow-up (P = 0.031, P = 0.006). There was no significant difference in the number of urinary leakages between the different systems at baseline (P = 0.662), although this was higher in the InterStim system group during the experience period (P = 0.016), and the difference disappeared at the last follow-up (P = 0.565). There were significant differences in baseline urgency perception scale (P = 0.001) and OAB-related quality of life score (P < 0.001) between the two groups; however, these differences were not maintained at follow-up (P = 0.81, P = 0.479). Both sacral neuromodulation systems are safe and effective in treating overactive bladder. The InterStim system may be more beneficial for patients with dry overactive bladder. Satisfactory outcomes may be achieved with the BetterStim system in patients with wet overactive bladder. However, further studies are required to confirm this finding.

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Section: Discussionsupporting

confidence: 86%

Sacral neuromodulation for overactive bladder using the InterStim and BetterStim systems

Meng

Tian

Zhang

et al. 2022

Sci Rep

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“…Overall, in our patient population, both short-term (94%) and long-term (76%) success rates of SNM were comparable or superior to those reported in other SNM studies, irrespective of the initial medical indication [11][12][13][14][15] . Outcomes of SNM for bladder and bowel disorders in elderly patients have also been evaluated by other studies.…”

Section: Discussionsupporting

confidence: 80%

Sacral neuromodulation in the golden years

Ferreira,

Otis-Chapados,

Alwashmi

et al. 2023

CUAJ

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Introduction: Despite high prevalence and increased severity and burden of overactive bladder (OAB) and fecal incontinence (FI) in the elderly, sacral neuromodulation (SNM) is often overlooked as a potential treatment option for this demographic. In this study, we report the outcomes of SNM in patients aged 75 years or older at the time of surgery. Methods: We conducted a retrospective cohort study of patients who underwent SNM implantation between 2013 and 2022 performed by a single high-volume urologist at a tertiary center. Success, complication, and adjunct therapy rates were analyzed by Fisher’s or Wilcox rank-sum test as appropriate. We compared outcomes between patients aged 75–79 years and octogenarians. Results: Of 632 patients, 50 were 75 years. Patients had a mean age of 78.4±2.6 years and were predominantly female (84%). The indications for SNM were 66% OAB, 16% FI, 16% non-obstructive urinary retention, and 4% pelvic pain. Within the first year, 94% of patients reported satisfaction and improvement in symptoms, while 76% continued to experience improvement beyond one year. SNM insertion led to reduced oral medication use from 68% to 24% (p<0.0001). The complication rate was 16% and mostly included device pain. No significant difference was observed in treatment success, complication, or adjunct therapy rate between age groups. Conclusions: SNM is a safe and effective option in well-selected patients over the age of 75 years. Treatment success rate is comparable to younger cohorts. Advanced age should not preclude third-line therapy options in this population.

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“…A further paper about device programming settings for RELAX-OAB provided additional detail [11]. Subsequent to the initial literature search, new peer-reviewed publications [12,13] verified the content of the previously unpublished papers.…”

Section: Review Of Clinical Effectiveness Evidencementioning

confidence: 99%

“…For the discontinuation rate of the non-rechargeable system, Cedar interpreted the available data [18] to give a 5-year discontinuation rate of 17% rather than 6%. Cedar also changed the clinical inputs for rechargeable systems, to be based on studies using the rechargeable system [8][9][10][11]13] rather than data from the Insite study [17]. The probability of lead migration or fracture was changed to be constant throughout the model, meaning it was no longer occurring only in the cycle with an implantation or revision procedure.…”

Section: Changes By Cedarmentioning

confidence: 99%

Axonics Sacral Neuromodulation System for Treating Refractory Overactive Bladder: A NICE Medical Technologies Guidance

Poole

Dale

Morgan

et al. 2021

Appl Health Econ Health Policy

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The Axonics sacral neuromodulation (SNM) system can be used by people with refractory overactive bladder (OAB) to reduce symptoms of urge urinary incontinence and urinary frequency, where conservative treatments have failed or are not suitable. It is the first system for this indication that makes use of a rechargeable battery to prolong the lifespan of the implanted device, with the potential advantage of reducing the frequency of surgical replacement procedures and associated complications. We describe the evidence considered by the UK National Institute of Health and Care Excellence (NICE) in their evaluation of this evidence, supported by Cedar Healthcare Technology Research Centre. Two observational studies provided descriptive data that suggested improvement in control of symptoms after implantation of the Axonics SNM system; however, there was no peer-reviewed evidence that directly compared rechargeable and non-rechargeable SNM systems. In the absence of long-term data, economic modelling relies on the accuracy of battery life estimates. The evidence supports the case for adopting the Axonics SNM system for treating refractory OAB, when conservative treatment or treatment with medicines has not worked. This conclusion is consistent with other relevant NICE guidelines. Use of Axonics SNM technology in the UK National Health Service (NHS) is associated with a potential cost saving of £6025 per person over a 15-year period when compared with an equivalent non-rechargeable SNM system, assuming the claimed battery life estimate (a minimum of 15 years) is accurate. The cost savings are estimated to start around 6 years after implantation. Key Points for Decision MakersPublished evidence from two non-comparative observational studies suggests that use of the Axonics Sacral Neuromodulation (SNM) system can help people with overactive bladder (OAB) to manage symptoms of urinary frequency and urinary incontinence.National Institute of Health and Care Excellence (NICE) concluded that the Axonics SNM system should be considered as an option for people with refractory OAB when conservative treatment or treatment with medicine has not worked.

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Two‐year safety and efficacy outcomes for the treatment of overactive bladder using a long‐lived rechargeable sacral neuromodulation system

Cited by 16 publications

References 21 publications

Sacral neuromodulation for overactive bladder using the InterStim and BetterStim systems

Sacral neuromodulation for overactive bladder using the InterStim and BetterStim systems

Sacral neuromodulation in the golden years

Axonics Sacral Neuromodulation System for Treating Refractory Overactive Bladder: A NICE Medical Technologies Guidance

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