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
Qualifiers
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
Treatments tested in this trial
- Medical device for SNM: Interstim X or Interstim micro
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov