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Enrolling by Invitation

NCT Number: NCT06212661

Migraine Medication Effects on Urinary Symptoms

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.

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Key information

Conditions

Overactive Bladder Bladder Pain Syndrome Brain Diseases Central Nervous System Diseases Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Headache Disorders Headache Disorders, Primary Interstitial Cystitis Lower Urinary Tract Symptoms Male Urogenital Diseases Migraine Migraine Disorders Nervous System Diseases Overactive Bladder Syndrome Overactive Detrusor Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cleveland Clinic, Main Campus

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ubrogepant

Drug

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

Other names: Ubrelvy

Rimegepant

Drug

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

Other names: Nurtec

Atogepant

Drug

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

Other names: Qulipta

Eptinezumab

Drug

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

Other names: Vyepti

Fremanezumab

Drug

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

Other names: Ajovy

Galcanezumab

Drug

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

Other names: Emgality

Erenumab

Drug

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

Other names: Aimovig

Botulinum toxin A

Drug

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

Other names: Botox

Primary outcomes

  1. changes in OAB symptoms

    Time frame: 3 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.

Secondary outcomes

  1. changes in bladder pain symptoms

    Time frame: 3 months

    To prospectively compare changes in bladder pain symptoms after beginning CGRP inhibitor treatment for migraine, with changes after beginning local BoNTA injections for migraine as controls.

    Bladder / pelvic pain symptom change will be measured using the Female Genitourinary Pain Index (GUPI). The score ranges from 0 to 39, quality of life question score from 0 to 6, and higher scores indicate worse symptoms.

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

    Time frame: 3 months

    To assess rates of LUTS (Lower Urinary Tract Symptoms) and LUTS-related quality of life (QoL) in patients with chronic refractory migraine.

    LUTS will be assessed using the International Consultation on Incontinence Questionnaire (ICIQ) - Female Lower Urinary Tract Symptoms (FLUTS). This questionnaire has 12 symptoms questions scored 0 to 4, overall questionnaire score is 0 to 48 points, and higher scores indicate worse symptoms.

    Bladder / pelvic pain symptoms will be measured using the Female Genitourinary Pain Index (GUPI). The score ranges from 0 to 39, higher scores indicate worse symptoms.

    LUTS-related quality of life question, adopted from the international prostate symptom score (IPSS) or American Urological Association symptom index (AUASI), is scored 0 to 6 and a higher score indicated worse quality of life.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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