Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
NCT ID: NCT06434831
Last Updated: 2024-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-07-02
2026-12-02
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ANI will be recorded during the SNM.
Medical device for SNM: Interstim II, Interstim micro
ANI will be used during the SNM (2 hours)
Interventions
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Medical device for SNM: Interstim II, Interstim micro
ANI will be used during the SNM (2 hours)
Eligibility Criteria
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Inclusion Criteria
* 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
* Sacral neuromodulation (last 3 months)
* Botulinum toxin A intra-detrusor injection (last 9 months)
* Pregnancy in progress
* Administrative reasons
* Guardianship/curatorship
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Other Identifiers
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2023_195
Identifier Type: -
Identifier Source: org_study_id
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