Migraine Medication Effects on Urinary Symptoms

NCT ID: NCT06212661

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-05
• Study Completion Date: 2026-12-31

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 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.

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 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CGRP inhibitor

• Ubrogepant (Ubrelvy™)
• Rimegepant (Nurtec®)
• Atogepant (Qulipta™)
• Eptinezumab (Vyepti®)
• Fremanezumab (Ajovy®)
• Galcanezumab (Emgality®)
• Erenumab (Aimovig®) dosage and duration according to provider's clinical decision.

Ubrogepant

Intervention Type: DRUG

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

Rimegepant

Intervention Type: DRUG

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

Atogepant

Intervention Type: DRUG

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

Eptinezumab

Intervention Type: DRUG

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

Fremanezumab

Intervention Type: DRUG

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

Galcanezumab

Intervention Type: DRUG

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

Erenumab

Intervention Type: DRUG

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

BoNTA extracranial muscle injections

Botolinum toxin A (Botox) Injection into extracranial muscles to treat migraine. Dosage and duration according to provider's clinical decision

Botulinum toxin A

Intervention Type: DRUG

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

Interventions

Ubrogepant

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

Intervention Type: DRUG

Rimegepant

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

Intervention Type: DRUG

Atogepant

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

Intervention Type: DRUG

Eptinezumab

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

Intervention Type: DRUG

Fremanezumab

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

Intervention Type: DRUG

Galcanezumab

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

Intervention Type: DRUG

Erenumab

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

Intervention Type: DRUG

Botulinum toxin A

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

Intervention Type: DRUG

Other Intervention Names

Ubrelvy; Nurtec; Qulipta; Vyepti; Ajovy; Emgality; Aimovig; Botox

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Howard Goldman, MD

Principal investigator / Professor and Vice Chair (Quality and Patient Safety) Glickman Urologic and Kidney Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Howard B Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic, Main Campus

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

23-1101

Identifier Type: -

Identifier Source: org_study_id