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NOT YET RECRUITING
NCT06434831
NA

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

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-07-02

Completion Date

2026-12-02

Last Updated

2024-05-30

Healthy Volunteers

No

Interventions

DEVICE

Medical device for SNM: Interstim II, Interstim micro

ANI will be used during the SNM (2 hours)