Trial reportNeuromodulation : journal of the International Neuromodulation Society2025
A First-In-Human Feasibility Study of a New Implantable Tibial Nerve Stimulator for Overactive Bladder Syndrome.
Trial report in Neuromodulation : journal of the International Neuromodulation Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04115228 (Clinical Feasibility Study, Implantable Tibial Nerve Stimulator), which is not on this map. Cited by 2 papers.
What it found
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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.
Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Who cites it
2 citing papers in PubMed.
- The impact of transcutaneous tibial nerve stimulation on brain function in patients with overactive bladder: a prospective longitudinal self-controlled study.Frontiers in human neuroscience · 2026Article
- Emerging Implantable Tibial Nerve Stimulation Devices for Overactive Bladder.International neurourology journal · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
objectivesThis study aimed to evaluate the preliminary feasibility and safety of a new implantable tibial nerve stimulator device in patients with overactive bladder (OAB). MATERIALS AND
methodsTen patients with OAB in whom conservative treatments had failed participated in the study. All patients received daily stimulation therapy for two weeks and weekly stimulation therapy for 13 weeks, at the lowest electrical output amplitude at which paresthesia or motor response occurred. OAB symptoms (three-day bladder diary), quality-of-life scores (OAB-questionnaire Short Form), and patient global response (GRA) were assessed at each follow-up visit.
resultsAmong the patients enrolled (mean age 68 years), seven were OAB-wet and three OAB-dry. After 13 weeks of therapy delivery, a reduction in the number of daily voids during waking hours (8.5 ± 2.5 to 6.3 ± 1.9; p = 0.016), incontinence episodes (2.5 ± 1.8 to 0.3 ± 0.5; p < 0.001), and the daily voids associated with urgency (7.6 ± 3.1 to 3.0 ± 3.1; p < 0.001) was reported. Eight of the ten subjects were classified as responders for ≥one OAB component, with one patient reporting worsened symptoms of urgency (+6%). All ten patients reported global improvement in symptoms on the GRA with a median score of 6. Improvements in OAB severity and health-related quality-of-life scores were noted from pre- to posttreatment across participants (p < 0.001). No serious adverse effects were noted.
conclusionThis first-in-human pilot study allowed for capture of preliminary safety and effectiveness information on a new implantable tibial nerve stimulator device in the population of interest to adequately power a larger, pivotal randomized study. CLINICAL
trial registrationThe Clinicaltrials.gov registration number for the study is NCT04115228.
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