NCT06434831 Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
| NCT ID | NCT06434831 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Bladder Hyperactivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-02-14 |
| Primary Completion | 2026-08-20 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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