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Enrolling by invitation NCT06212661

Migraine Medication Effects on Urinary Symptoms

— Observational Overactive Bladder Bladder Pain Syndrome Migraine Disorders Overactive Bladder Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ubrogepant, Rimegepant, Atogepant, Eptinezumab.
Who it may be relevant to
Registry conditions: Overactive Bladder, Bladder Pain Syndrome, Migraine Disorders, Overactive Bladder Syndrome. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Ubrogepant
    Ubrogepant (Ubrelvy™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
  • Drug Rimegepant
    Rimegepant (Nurtec®), 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.

Primary outcome measures

  • changes in OAB symptoms [Time frame: 3 months]
Secondary outcome measures (2)
  • changes in bladder pain symptoms [Time frame: 3 months]
  • rates of LUTS and LUTS-related quality of life (QoL) in patients with chronic refractory migraine. [Time frame: 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Cleveland Clinic, Main Campus — Cleveland

Identifiers

NCT: NCT06212661 · 23-1101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗