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Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Lille
NCT06434831 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Overactive bladder syndrome (OAB) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence. Sacral neuromodulation (SNM) is now one of the second-line treatments for OAB. The mode of action of SNM is still poorly understood but a number of data from recent scientific literature suggest that SNM may act, among other things, by altering the balance of the autonomic nervous system (ANS) - located at the interface between the urinary tract and the brain structures regulating the functioning of the urinary tract. The aim of this study would therefore be to develop a predictive tool for the effectiveness of SNM.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male of female ≥ 18 years * OAB syndrome * Indication for a two-staged SNM * Under general anaesthesia with Remifentanil and Propofol * Patient who has given written consent to participate in the trial * Patient willing to comply with all study procedures and duration Exclusion Criteria: * Tibial neuro-stimulation (last 3 months) * Sacral neuromodulation (last 3 months) * Botulinum toxin A intra-detrusor injection (last 9 months) * Pregnancy in progress * Administrative reasons * Guardianship/curatorship
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What it tests

  • Medical device for SNM: Interstim X or Interstim micro
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Where

1 site
chu de Lille
Lille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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