How sacral neuromodulation affects the autonomic nervous system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• chu de Lille
  Lille, France Recruiting

Study contacts

• Study coordinator: Dri
• Email: drs-promotion@chu-lille.fr
• Phone: 0033320444145

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.