Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study

Chartier‐Kastler, Emmanuel; Normand, L. Le; Ruffion, A.; Saussine, C.; Braguet, R.; Rabut, Bertrand; Ragni, E.; Perrouin‐Verbe, Marie‐Aimée; Pierrevelcin, Jean; Rousseau, Thierry; Gamé, X.; Tanneau, Yves; Dargent, François; Biardeau, Xavier; Graziana, Jean Pierre; Stoica, Gabriel; Brassart, É.; Fourmarier, M.; Yaghi, Najdat; Capon, G.; Ferchaud, Jérôme; Berrogain, N.; Peyrat, L.; Pecoux, F.; Bryckaert, Pierre-Emmanuel; Melotti, A.; Abouihia, Abdallah; Keller, D. U. J.; Cornu, Jean‐Nicolas

doi:10.1016/j.euf.2021.06.013

Cited by 6 publications

(4 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We also noted a 12.1% explant rate overall but found no difference based on cognitive status. Rates were similar to two contemporary “real‐world” SNM trials reporting 3‐year outcomes and 13% explant rates 25,26 . Conversely, the revision rate in this study of CI was only 10.4%, notably lower than the 20%–32% reported at 3 years in the “real‐world” studies.…”

Section: Discussionsupporting

confidence: 82%

“…Rates were similar to two contemporary "real-world" SNM trials reporting 3-year outcomes and 13% explant rates. 25,26 Conversely, the revision rate in this study of CI was only 10.4%, notably lower than the 20%-32% reported at 3 years in the "real-world" studies. This difference may stem from shorter follow-up, loss to follow-up, or differences in symptom reporting/pursuit of care secondary to CI in patients.…”

Section: Discussioncontrasting

confidence: 77%

See 1 more Smart Citation

Cognitive impairment does not impact sacral neuromodulation implant rates for overactive bladder

Zillioux

Lewis

Hettel

et al. 2023

Neurourology and Urodynamics

View full text Add to dashboard Cite

Objective To evaluate the impact of cognitive impairment (CI) diagnoses on sacral neuromodulation (SNM) outcomes in older patients. Materials and Methods We completed a retrospective review of all patients aged ≥55 years who underwent test‐phase SNM (peripheral nerve evaluation (PNE) or stage 1) for overactive bladder (OAB) between 2014 and 2021 within a large multi‐regional health system. Patient demographics, relevant comorbidities, CI diagnoses (dementia or mild CI), and SNM procedures were recorded. Logistic regression modeling was performed to evaluate the impact of CI on SNM implantation rates. Results Five‐hundred and ten patients underwent SNM test phase (161 PNE, 349 Stage 1) during the study period. The mean age was 71.0(8.5) years, and most (80.6%) were female. Overall, 52(10.1%) patients had a CI diagnosis at the time of SNM, and 30 (5.8%) were diagnosed at a median of 18.5 [9.25, 39.5] months after SNM. Patients with CI diagnoses were older, with more comorbidities, and were more likely to undergo PNE. Univariable comparison found no difference in implantation rate based on pre‐SNM CI (85.4% vs. 76.9%, p = 0.16). Multivariable analysis identified PNE (OR 0.43, 95% CI 0.26–0.71), age (OR 0.96, 95%CI 0.93‐0.98), and prior beta‐3 agonist use (OR 0.60, 95% CI 0.37‐0.99) but not CI or dementia as independent negative predictors of implantation. Implanted patients had a median follow‐up of 25 [12.0, 55.0] months. Explant and revision rates did not differ according to CI. Conclusion Patients with OAB and CI diagnoses proceed to SNM implant at rates similar to patients without CI diagnoses. A diagnosis of CI should not necessarily exclude patients from SNM therapy for refractory OAB.

show abstract

Section: Discussionsupporting

confidence: 82%

Section: Discussioncontrasting

confidence: 77%

Cognitive impairment does not impact sacral neuromodulation implant rates for overactive bladder

Zillioux

Lewis

Hettel

et al. 2023

Neurourology and Urodynamics

View full text Add to dashboard Cite

show abstract

“…Sacral nerve modulation therapy, as a first-line treatment for refractory neurogenic lower urinary tract dysfunction, has gained widespread promotion and application worldwide over the past decade, bringing significant clinical benefits to a large number of patients 15 – 17 . However, conventional sacral nerve modulation therapy is primarily conducted through in-person programming, requiring patients to visit a healthcare facility for each adjustment.…”

Section: Discussionmentioning

confidence: 99%

Remote programming in stage I sacral neuromodulation: a multicentre prospective feasibility study

Jing,

Meng,

Zhang

et al. 2024

International Journal of Surgery

View full text Add to dashboard Cite

Objective: Sacral neuromodulation (SNM) has emerged as an effective therapy for refractory lower urinary tract dysfunction (LUTD). Remote programming holds promise in addressing the time and economic burdens associated with outpatient programming, especially for patients in the observation period following Stage I implant surgery (where the lead is implanted first without the pulse generator). The study aimed to explore the effectiveness and patient satisfaction of remote programming for Stage I SNM patients, and analyze the benefits patients gain from remote programming. Methods: This prospective study was conducted at multiple high-level clinical SNM centers in China. Patients requiring SNM implantation were enrolled and divided into two groups based on patient preference: remote programming (RP) group and outpatient control (OC) group. Patient attitudes toward RP were assessed through questionnaires, and the degree of symptom improvement was compared between the two groups to explore the usability of RP. Results: A total of 63 participants from 6 centers were included in the study, with 32 belonging to the RP group. The remote programming system presents a high level of usability (98%) and willingness (satisfaction rate: 96.83%) in result of questionnaire. RP showed a significant advantage in improving patients’ score of ICSI/ICPI (medianΔICSI/ICPI RP vs OC= -13.50 vs -2, P=0.015). And slightly ameliorate urinary symptoms such as pain (medianΔVAS RP vs OC= -1 vs 0, P= 0.164 ) and urgency ( medianΔOBASS -2.5 vs -1, P= 0,229), but the difference was not statistically significant. RP did not significantly impact the quality of life of patients (P=0.113), so do the rate of phase-two conversion (P= 0.926) or programming parameters. Conclusion: To the best of our knowledge, the presented study is the first multicenter research focusing on the remote programming of Stage I SNM patients. Through the clinical implementation and patient feedback, we demonstrate that remote programming is not inferior to in-person programming in terms of success rate, effectiveness, safety, and patient satisfaction.

show abstract

“…Two prospective multi‐center trials with more than 300 participants each, the SOUNDS study which enrolled in 2014–2016 22 and the InSite trial which enrolled in 2007–2011, 23 found the most common AEs for patients implanted with an SNM device to be undesirable change in stimulation, IPG site pain, IPG site infection, battery failure, and user error, each of which occurred in 3%–12% of the patients in either study. The ROSETTA trial, which enrolled 2012–2014, randomized 174 patients with refractory UUI to SNM; regarding AEs, they found that within the 6 month follow‐up period 3% of patients had the SNM removed and 11% had UTIs 24 .…”

Section: Discussionmentioning

confidence: 99%

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database

Carlton

Souders

Chertack

et al. 2023

Neurourology and Urodynamics

View full text Add to dashboard Cite

IntroductionOver 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real‐world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation‐setting.Materials and MethodsThe FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98‐12/31/10) and keyword (1/1/11‐9/30/21) searches for “Interstim.” A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices.ResultsOur search of the MAUDE database returned 44 122 SNM‐related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non‐shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off‐label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury.ConclusionsThis review confirms the real‐world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%–46.3%) of SNM “complications” are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection—including at least one case in which SNM was used for a non‐FDA approved indication—lack of appropriate follow‐up, and/or provider inability to assist the patient with utilizing the device after implantation.

show abstract

Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study

Cited by 6 publications

References 27 publications

Cognitive impairment does not impact sacral neuromodulation implant rates for overactive bladder

Cognitive impairment does not impact sacral neuromodulation implant rates for overactive bladder

Remote programming in stage I sacral neuromodulation: a multicentre prospective feasibility study

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database

Contact Info

Product

Resources

About