By InvitationNot Applicable

Migraine Medication Effects on Urinary Symptoms

United States200 participantsStarted 2024-04-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

changes in OAB symptoms

Timeframe: 3 months

Trial details

NCT IDNCT06212661

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Overactive Bladder trials