Clinical trial NCT06212661: Migraine Medication Effects on Urinary Symptoms
Official title: Migraine Medication Effects on Urinary Symptoms
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Overactive Bladder
Bladder Pain Syndrome
Migraine Disorders
Overactive Bladder Syndrome
Overactive Detrusor
Migraine
Interstitial Cystitis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: changes in OAB symptoms
timeFrame: 3 months
Secondary outcomes:
measure: changes in bladder pain symptoms
timeFrame: 3 months
measure: rates of LUTS and LUTS-related quality of life (QoL) in patients with chronic refractory migraine.
timeFrame: 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Howard B Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References: