Migraine Medication Effects on Urinary Symptoms

NCT06212661 | Enrolling By Invitation

• 1 other identifier: 23-1101
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• changes in OAB symptoms

  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.

  3 months

Secondary Outcomes (2)

• changes in bladder pain symptoms

  3 months

• rates of LUTS and LUTS-related quality of life (QoL) in patients with chronic refractory migraine.

  3 months

Study Arms (2)

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.

Drug: Ubrogepant; Drug: Rimegepant; Drug: Atogepant; Drug: Eptinezumab; Drug: Fremanezumab; Drug: Galcanezumab; Drug: Erenumab

BoNTA extracranial muscle injections

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

Drug: Botulinum toxin A

Interventions

Ubrogepant DRUG

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

Also known as: Ubrelvy

CGRP inhibitor

Rimegepant DRUG

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

Also known as: Nurtec

CGRP inhibitor

Atogepant DRUG

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

Also known as: Qulipta

CGRP inhibitor

Eptinezumab DRUG

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

Also known as: Vyepti

CGRP inhibitor

Fremanezumab DRUG

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

Also known as: Ajovy

CGRP inhibitor

Galcanezumab DRUG

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

Also known as: Emgality

CGRP inhibitor

Erenumab DRUG

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

Also known as: Aimovig

CGRP inhibitor

Botulinum toxin A DRUG

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

Also known as: Botox

BoNTA extracranial muscle injections

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients age 18 years or over, presenting to the neurology outpatient clinics for treatment of refractory migraine with either CGRP inhibitors or Botulinum toxin extracranial muscle injections, and with at least 1 urinary storage-phase symptom in the past month.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic, Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Cystitis, Interstitial; Migraine Disorders

Interventions

ubrogepant; rimegepant sulfate; atogepant; eptinezumab; fremanezumab; erenumab; galcanezumab; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cystitis; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Howard B Goldman, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator / Professor and Vice Chair (Quality and Patient Safety) Glickman Urologic and Kidney Institute

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: April 5, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)