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Clinical Trial Summary

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.


Clinical Trial Description

Common urinary urgency syndromes may be related to over-activation of bladder afferent pathways involving CGRP signaling. CGRP (calcitonin gene related protein) is a neurotransmitter in afferent pathways also involved in central nociception and hypersensitization. CGRP-targeted therapies, approved for migraine treatment, have the potential to alleviate lower urinary tract symptoms, but these possible effects have not been studied in humans. This is a prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06212661
Study type Observational
Source The Cleveland Clinic
Contact
Status Enrolling by invitation
Phase
Start date April 5, 2024
Completion date May 2026

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