An observational study in Overactive Bladder, Bladder Pain Syndrome and Migraine Disorders, sponsored by The Cleveland Clinic. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by The Cleveland Clinic · Observational
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.
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 169 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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CGRP inhibitors, including:
Any of the following symptoms during the last month:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
Botolinum toxin A (Botox) Injection into extracranial muscles to treat migraine. Dosage and duration according to provider's clinical decision
Drug: Botulinum toxin A
Ubrogepant (Ubrelvy™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
Also known as: Ubrelvy
Rimegepant (Nurtec®), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
Also known as: Nurtec
Atogepant (Qulipta™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
Also known as: Qulipta
Eptinezumab (Vyepti®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
Also known as: Vyepti
Fremanezumab (Ajovy®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
Also known as: Ajovy
Galcanezumab (Emgality®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
Also known as: Emgality
Erenumab (Aimovig®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
Also known as: Aimovig
Botolinum toxin A (Botox) injections into extracranial muscles, dosage at discretion of clinical provider, for treatment of migraines.
Also known as: Botox
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
Plan to share: No — no plan to share with other researchers
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Jun 2027, 38 months after the start.
Of 46 non-industry observational studies under Urinary Bladder, Overactive, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's planned 38 months is close to that.
Counting every sponsor, half of 59 studies reached it within 32 months; a quarter within 17 and three quarters within 45.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 19, 2026: primary completion May 2026 → Jun 2027 and completion Dec 2026 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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