Bladder Hyperactivity, Sacral Neuromodulation
Conditions
Keywords
Bladder hyperactivity, autonomic nervous system, sacral neuromodulation, urodynamic assessment, heart rate variability
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.
Interventions
DEVICEMedical device for SNM: Interstim X or Interstim micro
ANI will be used during the SNM (2 hours)
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
Countries
France
Contacts
CONTACTDRI
Outcome results
None listed