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

Not Applicable

Not yet recruiting

• Conditions: Bladder Hyperactivity; Sacral Neuromodulation

• Registration Number: NCT06434831
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Study Start: 2024-07-02
• Primary Completion: 2026-12-02
• Study Completion: 2026-12-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comparison of HFVI analysed through HRV at baseline and during standardized stimulation protocol randomly delivered at the level of the 4contact points of the quadripolar lead at the time of lead implantation between the effective and noneffective groups	1 year	Comparison of HFVI (high frequence variability index) analysed through heart rate variability (HRV) at baseline and during a standardized stimulation protocol (14 Hz, 210 mcs, amplitude to elicit anal motor response) randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation, between the effective and non-effective groups.

Secondary Outcome Measures

Name	Time	Method
Comparison of other HRV parameters at baseline and during a standardized stimulation protocol randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation	1 year	Comparison of other HRV parameters (SDNN, RMSSD, HF, LF) at baseline and during a standardized stimulation protocol (14 Hz, 210 mcs, amplitude to elicit anal motor response) randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation,