Status:
TERMINATED
Effectiveness of HYPNOsis Masks During Botulinum TOXin Injections in Idiopathic Overactive Bladder(HypnoTox)
Lead Sponsor:
Centre Hospitalier de Roubaix
Conditions:
Idiopathic Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Monocenter, prospective, randomized, parallel group study (1:1) evaluating the efficacy of self-hypnosis performed by mask on pain and anxiety in patients receiving botulinum toxin injections in the t...
Detailed Description
Day 0: 1st consultation for overactive bladder refractory to drug treatment: verification of inclusion and non-inclusion criteria. Proposal of the study to the patient and handing over of the informat...
Eligibility Criteria
Inclusion
- Woman with non-neurological overactive bladder, confirmed by urodynamic assessment and cystoscopy, having resisted a well-conducted pharmacological treatment (trials of various anticholinergics).
- Age over 18 years
- Having understood the study and agreed to participate (signing of informed consent)
- Beneficiary of a health insurance plan
Exclusion
- Neurological patient: tetraplegic, paraplegic, multiple sclerosis for a reliable pain assessment
- Patients who have already been injected with botulinum toxin in the treatment of this pathology.
- Psychiatric pathology at risk of decompensation with self-hypnosis
- Patients who are difficult to assess because of a psychological disorder that does not allow them to answer questionnaires and pain assessment scales
- Patients under court protection, guardianship or curatorship
Key Trial Info
Start Date :
November 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05352945
Start Date
November 25 2022
End Date
June 25 2024
Last Update
July 10 2024
Active Locations (1)
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1
CH de Roubaix
Roubaix, France, 59100