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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-02-14 with a primary completion date of 2026-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06434831 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Hyperactivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06434831 currently recruiting?
Yes, NCT06434831 is actively recruiting participants. Contact the research team at drs-promotion@chu-lille.fr for enrollment information.
Where is the NCT06434831 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT06434831 clinical trial?
NCT06434831 is sponsored by University Hospital, Lille. The trial plans to enroll 40 participants.