Abstract
Purpose
The aim of this prospective 12-month follow-up study is to evaluate the persistence of the treatment effect achieved during the initial course of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in patients with overactive bladder (OAB).
Methods
This study enrolled 21 female patients who participated in two previous clinical studies designed to assess the efficacy and safety of peroneal eTNM®. The patients were left without subsequent OAB treatment and were invited to attend regular follow-up visits every 3 months. The patient’s request for additional treatment was considered an indicator of the withdrawal of the treatment effect of the initial course of peroneal eTNM®. The primary objective was the proportion of patients with persisting treatment effect at follow-up visit 12 months after initial course of peroneal eTNM®. Descriptive statistics are presented using median, correlation analyses were computed using a nonparametric Spearman correlation.
Results
The proportion of patients with persistent therapeutic effect of the initial course of peroneal eTNM® was 76%, 76%, 62% and 48% at 3, 6, 9 and 12 months, respectively. There was a significant correlation between patient reported outcomes and the number of severe urgency episodes with or without urgency incontinence as reported by patients at each follow-up visit (p = 0.0017).
Conclusion
The treatment effect achieved during the initial phase of peroneal eTNM® persists for at least 12 months in 48% of patients. It is likely that the duration of effects is dependent on the length of the initial therapy.
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Data availability
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Acknowledgements
The authors are grateful to L. Horčička and L. Slobodník for their contribution to the data acquisition.
Funding
The primary trials were funded by STIMVIA™, Ostrava, Czech Republic. The present follow-up study did not receive any funding from public or private sources.
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MR: contributed to study concept, data acquisition, data analysis, and manuscript revision; JK: contributed to study concept, study design, data acquisition, data analysis, interpretation of data, and manuscript writing; MG: contributed to study concept, data acquisition, and manuscript revision; BFMB: contributed to study concept, study design, data analysis, interpretation of data, manuscript revision, and supervision; PZ: contributed to study design, data analysis, interpretation of data, manuscript writing, manuscript editing, and supervision.
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Conflict of interest
Michal Rejchrt is an investigator for STIMVIA; Jan Krhut is a consultant and investigator for STIMVIA; Marcel Gärtner an investigator for STIMVIA; Bertil Blok is a member of the Scientific Advisory Board at STIMVIA; Peter Zvara has no conflicts of interest to declare.
Informed consent
Informed consent was obtained from all individual participants included in the study.
Research involving human participants and/or animals
The study was conducted in accordance with the principles of the Declaration of Helsinki, World Medical Association. An independent institutional ethics committee of Příbram Regional Hospital approved this study protocol, data collection plan, and ICF (Nr.PB205/21). The primary trials were registered under ClinicalTrial.gov nr. 05211193 and EudraCT nr. 2019-003321-14.
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Rejchrt, M., Krhut, J., Gärtner, M. et al. Effect duration of the initial course of peroneal electrical Transcutaneous NeuroModulation in patients with overactive bladder. World J Urol 41, 1629–1634 (2023). https://doi.org/10.1007/s00345-023-04394-z
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DOI: https://doi.org/10.1007/s00345-023-04394-z