NCT06434831

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Hyperactivity
• Sacral Neuromodulation

Interventions

Type	Name	Description
DEVICE	Medical device for SNM: Interstim II, Interstim micro	ANI will be used during the SNM (2 hours)

Timeline

• Start date: 2024-07-02
• Primary completion: 2026-12-02
• Completion: 2026-12-02
• First posted: 2024-05-30
• Last updated: 2024-05-30