How sacral neuromodulation affects the autonomic nervous system
Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
We will test whether sacral neuromodulation changes autonomic nervous system activity in adults with overactive bladder who are undergoing a two-stage SNM implant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT06434831 on ClinicalTrials.gov |
What this trial studies
Adults with overactive bladder scheduled for a two-stage sacral neuromodulation implant at CHU de Lille will undergo urodynamic testing and autonomic measurements including heart rate variability before and during device stimulation. The study uses commercial InterStim X or InterStim Micro devices and records physiological responses under standardized general anesthesia with remifentanil and propofol to characterize ANS changes linked to stimulation. Investigators will compare urodynamic parameters and autonomic signals to identify patterns associated with clinical response. The aim is to develop a predictive tool to help determine which patients are likely to benefit from SNM.
Who should consider this trial
Good fit: Adults (age ≥18) with overactive bladder who are candidates for a two-stage sacral neuromodulation implant and can undergo general anesthesia are the ideal participants.
Not a fit: People who recently had tibial nerve stimulation or sacral neuromodulation, recent intradetrusor botulinum toxin, pregnant individuals, or those under guardianship are unlikely to qualify and may not benefit from the study's findings.
Why it matters
Potential benefit: If successful, the study could help predict who will respond to sacral neuromodulation and reduce unnecessary implants.
How similar studies have performed: Small physiologic studies have suggested SNM can alter autonomic measures such as heart rate variability, but leveraging these signals as a reliable predictive tool remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille
- chu de Lille — Lille, France (Recruiting)
Study contacts
- Study coordinator: Dri
- Email: drs-promotion@chu-lille.fr
- Phone: 0033320444145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.