Migraine Medication Effects on Urinary Symptoms

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.

Conditions

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

Interventions

DRUG

Rimegepant

Rimegepant (Nurtec®), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.

DRUG

Ubrogepant

Ubrogepant (Ubrelvy™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.

DRUG

Atogepant

Atogepant (Qulipta™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.

DRUG

Eptinezumab

Eptinezumab (Vyepti®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.

DRUG

Fremanezumab

Fremanezumab (Ajovy®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.

DRUG

Galcanezumab

Galcanezumab (Emgality®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.

DRUG

Erenumab

Erenumab (Aimovig®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.

DRUG

Botulinum toxin A

Botolinum toxin A (Botox) injections into extracranial muscles, dosage at discretion of clinical provider, for treatment of migraines.

Sponsors & Collaborators

• The Cleveland Clinic

  lead OTHER

Principal Investigators

• Howard B Goldman, MD · The Cleveland Clinic

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-05

Primary Completion

2026-05-31

Completion

2026-12-31

Countries

• United States

Study Locations