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NCT Number: NCT06434831

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

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.

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Key information

Conditions

Bladder Hyperactivity Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Sacral Neuromodulation Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical device for SNM: Interstim X or Interstim micro

Device

ANI will be used during the SNM (2 hours)

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

    Time frame: 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 outcomes

  1. 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

    Time frame: 1 year

    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.

  2. 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

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

DRI

CONTACT

[email protected]

0033320444145

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: ESTIME

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 30, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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