Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male of female ≥ 18 years
OAB syndrome
Indication for a two-staged SNM
Under general anaesthesia with Remifentanil and Propofol
Disqualifiers
Tibial neuro-stimulation (last 3 months)
Sacral neuromodulation (last 3 months)
Botulinum toxin A intra-detrusor injection (last 9 months)
Pregnancy in progress
Trial design
Design model
Single group
Treatments tested in this trial
Medical device for SNM: Interstim X or Interstim micro
DeviceANI will be used during the SNM (2 hours)
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: ANI (Analgesia nociception index) will be recorded during the SNM (Sacral neuromodulation).Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
1 yearSecondary 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
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.
Time frame
1 year2
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov