Status:
ENROLLING_BY_INVITATION
Migraine Medication Effects on Urinary Symptoms
Lead Sponsor:
The Cleveland Clinic
Conditions:
Overactive Bladder
Bladder Pain Syndrome
Eligibility:
FEMALE
18+ years
Brief 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 t...
Detailed 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 pathw...
Eligibility Criteria
Inclusion
- Female Patients \> 18 years
- Refractory migraine, planned treatment with either:
- CGRP inhibitors, including:
- CGRP small molecule receptor antagonists ("gepants"): Ubrogepant, Rimegepant, Atogepant.
- CGRP monoclonal antibodies: Eptinezumab, Fremanezumab, Galcanezumab.
- CGRP receptor monoclonal antibodies: Erenumab.
- BoNTA extracranial muscle injections
- Any of the following symptoms during the last month:
- Urinating too often (frequency).
- Having a sudden urge to urinate that's difficult to hold back (urgency).
- Having a sudden urge to urinate and urine leaking before you make it to the toilet (urge incontinence).
Exclusion
- Age \< 18 years
- CGRP treatment within the last 12 months or BoNTA (head / bladder) last 6 months.
- Patient (or medical decision-maker) unable to provide informed consent or unable to answer questionnaire.
- Unable to urinate, eg: post cystectomy, indwelling catheter, on intermittent self catheterization, ESRD w/ anuria.
- Prior bladder BoNTA in last 12 months.
Key Trial Info
Start Date :
April 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06212661
Start Date
April 5 2024
End Date
December 1 2026
Last Update
October 1 2025
Active Locations (1)
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1
Cleveland Clinic, Main Campus
Cleveland, Ohio, United States, 44195