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

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.

Study Overview

• Status: Recruiting
• Conditions: Sacral Neuromodulation; Bladder Hyperactivity
• Intervention / Treatment: Device: Medical device for SNM: Interstim X or Interstim micro

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DRI; Phone Number: 0033320444145; Email: drs-promotion@chu-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • CHU de Lille
    • Contact: DRI; Phone Number: 0033320444145; Email: drs.promotion@chu-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANI (Analgesia nociception index) will be recorded during the SNM (Sacral neuromodulation).	Device: Medical device for SNM: Interstim X or Interstim micro; ANI will be used during the SNM (2 hours)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Comparison of time-domain heart rate variability parameters at baseline and during a standardized electrical stimulation protocol (14 Hz, 210 µs, amplitude to elicit anal motor response) randomly delivered at the level of the four contact points of the quadripolar lead at the time of lead implantation.	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	Comparison of frequency-domain heart rate variability parameters at baseline and during a standardized electrical stimulation protocol (14 Hz, 210 µs, amplitude to elicit anal motor response) randomly delivered at the level of the four contact points of the quadripolar lead at the time of lead implantation.	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): December 2, 2026

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: autonomic nervous system; heart rate variability; sacral neuromodulation; Bladder hyperactivity; urodynamic assessment
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive; Equipment and Supplies
• Other Study ID Numbers: 2023_195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No