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

Recruiting now · Not applicable

Conditions studied: Bladder Hyperactivity, Sacral Neuromodulation

In brief

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.

Key facts

Study ID

NCT06434831

Run by

University Hospital, Lille

People needed

40

Starts

2024-02-14

Expected to finish

2026-12-02

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• chu de Lille — Lille, France (enrolling)

Full record on ClinicalTrials.gov

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