An interventional study of Medical device for SNM: Interstim X or Interstim micro in Bladder Hyperactivity and Sacral Neuromodulation, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
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Exclusion Criteria:
Device: Medical device for SNM: Interstim X or Interstim micro
ANI will be used during the SNM (2 hours)
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 year
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 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.
Time frame: 1 year
Plan to share: No
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