Dataset Information

Intermediate-term results of a prospective, multicenter study on remote programming sacral neuromodulation for refractory overactive bladder.

ABSTRACT:

Background

To evaluate the efficacy and safety of a novel remote programming sacral neuromodulation (SNM) system (BetterStim system) in the treatment of patients with refractory overactive bladder (OAB) for 3 years.

Methods

A total of 8 centers in China enrolled 84 patients with OAB. Following test stimulation 70 patients underwent implantation using BetterStim. All patients returned for follow-up at 3 and 6 months postoperatively. After that, the visits were conducted by telephone. Outcomes of voiding diaries, the overactive bladder symptom score (OABSS), questionnaires regarding OAB-related quality of life (OAB-qol), and adverse events (AEs) were evaluated at each visit. The clinical therapeutic success was defined as ≥50% improvement from baseline in any of the voiding diary variables or average voids/day return to normal voiding (<8 voids/day). The analysis is a modified Completers analysis.

Results

At the 36-month follow-up, the success rate was 79% for overall OAB symptoms, 69% for urge urinary incontinence (UUI) and 42% for urgency frequency (UF). The average number of voids/day decreased from 29.2±14.9 at baseline to 17.6±11.2 at 3 years, the average volume/void increased from 94.7±54.2 to 151.4±80.8 mL, the urgency reduced from 3.0±1.4 to 1.8±1.7 (all P<0.001). For patients with urge incontinence, mean leaking episodes/day decreased from 8.1±7.6 at baseline to 2.1±3.5 at three years (P<0.05). The devices were explanted in 8 (11.4%) patients. There were no remote programming-related AEs or device-related serious AEs that occurred.

Conclusions

The Intermediate-term results demonstrated that BetterStim SNM system with remote programming is safe and effective for patients with refractory OAB.

SUBMITTER: Zhang Y

PROVIDER: S-EPMC8185673 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Publications

Intermediate-term results of a prospective, multicenter study on remote programming sacral neuromodulation for refractory overactive bladder.

Zhang Yaoguang Y Meng Lingfeng L Zhang Peng P Tian Xiaojun X Chen Guoqing G Li Yan Y Zhang Yong Y Xu Zhihui Z Wei Zhongqing Z Zhang Wei W Ma Lulin L Shi Benkang B Liao Limin L Wang Jianye J

Translational andrology and urology 20210501 5

<h4>Background</h4>To evaluate the efficacy and safety of a novel remote programming sacral neuromodulation (SNM) system (BetterStim system) in the treatment of patients with refractory overactive bladder (OAB) for 3 years.<h4>Methods</h4>A total of 8 centers in China enrolled 84 patients with OAB. Following test stimulation 70 patients underwent implantation using BetterStim. All patients returned for follow-up at 3 and 6 months postoperatively. After that, the visits were conducted by telephon ...[more]

PMID: 34159077

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Project description:ObjectiveSacral 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.MethodsThis 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.ResultsA 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.ConclusionTo 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.

Project description:ObjectivesSacral neuromodulation is an effective, minimally invasive treatment for refractory lower urinary tract dysfunction. However, regular postoperative programming is crucial for the maintenance of the curative effects of electronic sacral stimulator devices. The outbreak of coronavirus disease 2019 (COVID-19) limited the ability of practitioners to perform traditional face-to-face programming of these stimulators. Therefore, this study aimed to evaluate the application of remote programming technology for sacral neuromodulation during the COVID-19 pandemic in China.Materials and methodsWe retrospectively collected data including baseline and programming information of all patients with lower urinary tract dysfunction who underwent sacral neuromodulation remote programming in China after the outbreak of COVID-19 (i.e., December 2019). The patients also completed a self-designed telephone questionnaire on the subject.ResultsA total of 51 patients from 16 centers were included. They underwent 180 total remote programming visits, and 118, 2, 25, and 54 voltage, current, pulse width, and frequency adjustments, respectively, were performed. Additionally, remote switching on and off was performed 8 times; impedance test, 54 times; and stimulation contact replacement, 25 times. The demand for remote programming was the highest during the first 6 months of sacral neuromodulation (average, 2.39 times per person). In total, 36 out of the 51 patients completed the questionnaire survey. Of these, all indicated that they chose remote programming to minimize unnecessary travel because they had been affected by COVID-19. The questionnaire also showed that remote programming could reduce the number of patient visits to the hospital, save time, reduce financial costs, and would be easy for patients to master. All surveyed patients indicated that they were satisfied with remote programming and were willing to recommend it to other patients.ConclusionRemote programming for sacral neuromodulation is feasible, effective, safe, and highly recommended by patients with refractory lower urinary tract dysfunction. Remote programming technology has great development and application potential in the post-pandemic era.

Project description:BackgroundThe curative effect of sacral neuromodulation (SNM), used to treat overactive bladder (OAB) patients, is definite. However, some patients still have recurrent symptoms after SNM and unsatisfactory symptom improvement after repeated adjustments of the stimulation parameters combined with oral drugs. These are referred to as black-zone OAB patients. The described SNM is the standard method, which involves a constant-frequency stimulation (CFS) of the patient's specific sacral nerve. A new treatment strategy, which combines the advantages of high-frequency and low-frequency stimulations to generate variable-frequency stimulation (VFS), has not yet undergone a formal randomized clinical trial. Therefore, we designed this clinical trial to evaluate the efficacy and safety of VFS-SNM and CFS-SNM in the treatment of black-zone OAB patients.MethodsWe designed a multicenter, prospective, randomized, blinded, self-controlled trial with a 12-week follow-up period. The trial randomly divides the enrolled patients into CFS-SNM and VFS-SNM groups. The main evaluation index is the comparative effectiveness of VFS-SNM and CFS-SNM at the last follow-up. The secondary evaluation indices include the change in the OAB symptom score, the quality of life (QOL) score, and the visual analog scale compared with the baseline period at each follow-up time point.DiscussionPrevious studies and our pre-experimental results suggest that black-zone OAB patients may benefit from VFS-SNM. Twelve weeks of VFS-SNM are effective in 40%, and the non-inferior cutoff value is 10% (80% power, 0.05 significance level, 20% loss to follow up). Thus, the calculated sample size is 37 cases each for CFS and VFS groups. The trial is expected to be carried out in 18 centers, but centers will be added or removed as appropriate depending on specific implementation conditions. Clinical researchers at each center will be responsible for screening qualified participants. This is the first randomized controlled trial to comprehensively evaluate the efficacy and safety of VFS-SNM in black-zone OAB patients, which will provide high-quality clinical evidence and may provide new clinical options for such patients.Trial registrationChinese Clinical Trial Registry: ChiCTR2000036677, registration date: 24 August 2020.

Project description:Overactive bladder (OAB) is a common urological disease, reducing patient quality of life (QoL). Sacral neuromodulation (SNM) is a treatment option used when conservative treatment is inadequate. However, constant frequency stimulation-SNM (CFS-SNM) may not be sufficiently effective in achieving targeted symptom reduction in some patients. For such black-zone patients, a different treatment strategy is needed. Variable frequency stimulation (VFS) has been used for deep-brain stimulation treatment in patients with Parkinson's disease with positive outcomes. Accordingly, in this study, we hypothesized the promising outcomes of VFS-SNM in black-zone OAB patients. Here, we evaluated the efficacy and safety of VFS-SNM viz-a-viz CFS-SNM in a black-zone patient with refractory OAB whose frequent micturition symptoms were not relieved after undergoing traditional conservative treatment. A 50-year-old male patient was treated with CFS-SNM at our hospital in October 2016, but his symptoms recurred after administering multiple medications and program-controlled parameter adjustments. We then treated the patient with VFS-SNM in March 2020. A 2-week follow-up through telephonic interviews was conducted; the improvements in voiding symptoms were evaluated by calculating the OAB symptom score (OABSS) and OAB-related QoL (OAB-QoL) score. We observed that OABSS was significantly lower after VFS-SNM than after CFS-SNM. Further, we observed that VFS-SNM significantly improved daytime and nocturnal micturition frequency, as evident from the reduced OABSSs from after CFS-SNM to after VFS-SNM. The main reason for patient dissatisfaction after CFS-SNM was the increased average daily micturition frequency and urgency. VFS-SNM controlled the micturition frequency to within the patient's acceptable range, significantly improving the patient's QoL (40% improvement in OAB-QoL score). To the best of our knowledge, this is the first case report on the use of VFS-SNM with positive outcomes in a black-zone OAB patient, suggesting that VFS-SNM is not inferior to CFS-SNM in the treatment of black-zone patients.

Dataset Information

Intermediate-term results of a prospective, multicenter study on remote programming sacral neuromodulation for refractory overactive bladder.

Background

Methods

Results

Conclusions

Publications

Intermediate-term results of a prospective, multicenter study on remote programming sacral neuromodulation for refractory overactive bladder.

Similar Datasets

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