Migraine Medication Effects on Urinary Symptoms

Migraine Clinical Trial

Official title:

Migraine Medication Effects on Urinary Symptoms

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06212661
• Other study ID #: 23-1101
• Status: Enrolling by invitation
• Start date: April 5, 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Migraine
• Migraine Disorders
• Overactive Bladder
• Overactive Bladder Syndrome
• Overactive Detrusor
• Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• Ubrogepant
Ubrogepant (Ubrelvy™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
• Rimegepant
Rimegepant (Nurtec®), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
• Atogepant
Atogepant (Qulipta™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
• Eptinezumab
Eptinezumab (Vyepti®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
• Fremanezumab
Fremanezumab (Ajovy®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
• Galcanezumab
Galcanezumab (Emgality®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
• Erenumab
Erenumab (Aimovig®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
• Botulinum toxin A
Botolinum toxin A (Botox) injections into extracranial muscles, dosage at discretion of clinical provider, for treatment of migraines.

Locations

Country	Name	City	State
United States	Cleveland Clinic, Main Campus	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	changes in bladder pain symptoms	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.	3 months
Secondary	rates of LUTS and LUTS-related quality of life (QoL) in patients with chronic refractory migraine.	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.	3 months