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NCT06212661

Migraine Medication Effects on Urinary Symptoms

Enrolling by Invitation
Not specifiedAges 18+Observational
The Cleveland Clinic
~200 participants
Updated 2025-10-01 on ClinicalTrials.gov
What's tested:UbrogepantRimegepantAtogepantEptinezumabFremanezumabGalcanezumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
changes in OAB symptoms
Measured over 3 months

Conditions

Overactive Bladder
Bladder Pain Syndrome
Migraine Disorders
Overactive Bladder Syndrome
Overactive Detrusor
Migraine
Interstitial Cystitis

Explore related trials

Chronic primary bladder pain syndromeInterstitial CystitisMigraineOveractive Bladder

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Howard B Goldman, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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.

What this trial measures

  • changes in OAB symptoms3 months

    To prospectively compare changes in OAB symptoms after beginning CGRP inhibitor treatment for migraine, with changes after beginning local BoNTA injections for migraine as controls. OAB symptom change will be measured using the International Consultation on Incontinence Questionnaire (ICIQ) - Female Lower Urinary Tract Symptoms (FLUTS). ICIQ-FLUTS questionnaire composite OAB score, including urgency, frequency, nocturia and urge incontinence domains (range: 0-16, higher scores indicate worse symptoms). Differences of 2-4 points with a standard deviation of 3-4 points were reported as significant in the literature.