Trial reportWorld journal of urology2019
Remotely programmed sacral neuromodulation for the treatment of patients with refractory overactive bladder: a prospective randomized controlled trial evaluating the safety and efficacy of a novel sacral neuromodulation device.
Trial report in World journal of urology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.
- Reprogramming Sacral Neuromodulation for Sub-Optimal Outcomes: Evidence and Recommendations for Clinical Practice.Neuromodulation : journal of the International Neuromodulation Society · 2021Pooled it
- Advancing women's health: innovative applications of sacral neuromodulation in pelvic floor dysfunctions.Archives of gynecology and obstetrics · 2025Review
- Sacral neuromodulation remote programming in patients with refractory lower urinary tract dysfunction: China's experience during the COVID-19 pandemic.Frontiers in medicine · 2023Article
- Physical Agent-Based Treatments for Overactive Bladder: A Review.Journal of clinical medicine · 2022Review
- Telemedicine in Surgical Care in Low- and Middle-Income Countries: A Scoping Review.World journal of surgery · 2022Article
- Randomized clinical trials assessing third-line therapies to treat non-neurogenic overactive bladder syndrome: a review about methodology.International urogynecology journal · 2021Review
- Intermediate-term results of a prospective, multicenter study on remote programming sacral neuromodulation for refractory overactive bladder.Translational andrology and urology · 2021Article
- Variable- versus constant-frequency sacral neuromodulation in black-zone overactive bladder patients: a study protocol for a multicenter, prospective, randomized, blind, self-controlled trial.Translational andrology and urology · 2021Article
- Variable frequency stimulation of sacral neuromodulation in black-zone overactive bladder patients: a case report.Translational andrology and urology · 2020Article
- [Application and progress of neuromodulation in lower urinary tract dysfunction].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2020Review
- [Sacral neuromodulation in under- and overactive detrusor-quo vadis? : Principles and developments].Der Urologe. Ausg. A · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 7 institutions in 1 country.
Funding
Abstract
purposeThe efficacy and safety of a novel remotely programmed BetterStim sacral neuromodulation (SNM) system was evaluated in patients with refractory overactive bladder (OAB) in a prospective, controlled, multicenter trial.
methodsA total of 84 patients referred for SNM therapy from October 2015 to January 2018 were studied. Of the patients who qualified for implantation, 37 and 33 were randomly assigned to treatment and control groups, respectively. Patients in the treatment group underwent stimulation upon implantation, while stimulation was delayed in the control group for 3 months. Follow-up visits, consisting of voiding diary outcome, questionnaires regarding overactive bladder symptom score (OABSS) and quality of life were conducted at 1, 3, and 6-month post-implantation.
resultsCompared with the control group, subjects in the treatment group exhibited statistically significant improvement in OAB symptoms at 3 months. The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months. At 6 months, there were no significant differences in key voiding diary variables between the two groups. Further, this study demonstrated sustained improvement in urinary symptom interference in OAB patients. In addition, nearly all patients expressed great satisfaction with the remote-programming methods. No serious adverse events occurred, and device-related adverse events rate was 12.86%.
conclusionThis clinical study demonstrates subjective and objective success of the BetterStim SNM system. Importantly, our data suggest that remote programming can be safely used as a viable option for the conventional programming with a high degree of patient satisfaction.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.