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

NCT06434831 | Recruiting

• 1 other identifier: 2023_195
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Hyperactivity; Sacral Neuromodulation

Keywords

Bladder hyperactivity; autonomic nervous system; sacral neuromodulation; urodynamic assessment; heart rate variability

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  1 year

Secondary Outcomes (2)

• SDNN (Standard Deviation of all normal-to-normal RR intervals (milliseconds)) and RMSSD (Root Mean Square of Successive Differences between normal-to-normal RR intervals (milliseconds)) at baseline and during standardized electrical stimulation

  1 year

• LF (Low-Frequency power of heart rate variability (ms²)) and HF (High-Frequency power of heart rate variability (ms²)) components of heart rate variability at baseline and during standardized electrical stimulation

  1 year

Study Arms (1)

ANI (Analgesia nociception index) will be recorded during the SNM (Sacral neuromodulation).

EXPERIMENTAL

Device: Medical device for SNM: Interstim X or Interstim micro

Interventions

Medical device for SNM: Interstim X or Interstim micro DEVICE

ANI will be used during the SNM (2 hours)

ANI (Analgesia nociception index) will be recorded during the SNM (Sacral neuromodulation).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

chu de Lille

Lille, France

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

DRI

CONTACT

0033320444145; drs-promotion@chu-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: May 30, 2024
• Study Start: February 14, 2024
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)