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

University Hospital, Lille

Status: Not yet enrolling

Conditions: Bladder Hyperactivity; Sacral Neuromodulation

Treatments: Device: Medical device for SNM: Interstim II, Interstim micro

Study type: Interventional

Funder types: Other

Identifiers

NCT06434831

2023_195

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

ANI will be recorded during the SNM.

Experimental group

Treatment:

Device: Medical device for SNM: Interstim II, Interstim micro