Overactive BladderNCT06212661
Migraine Medication Effects on Urinary Symptoms
An observational study of Overactive Bladder and Bladder Pain Syndrome, run by The Cleveland Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder, Bladder Pain Syndrome, Migraine Disorders
- What is being tested?
- Ubrogepant, Rimegepant and Atogepant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 11Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic, Main Campus
Cleveland, Ohio, 44195
About this study
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.
Read the 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.
- Conditions
- Overactive Bladder, Bladder Pain Syndrome, Migraine Disorders, Overactive Bladder Syndrome, Overactive Detrusor, Migraine
- Being tested
- Ubrogepant, Rimegepant, Atogepant, Eptinezumab, Fremanezumab
- Medical subject headings
- Urinary Bladder, Overactive, Cystitis, Interstitial, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UbrogepantDrug
Also called Ubrelvy
Ubrogepant (Ubrelvy™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
RimegepantDrug
Also called Nurtec
Rimegepant (Nurtec®), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
AtogepantDrug
Also called Qulipta
Atogepant (Qulipta™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
EptinezumabDrug
Also called Vyepti
Eptinezumab (Vyepti®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
FremanezumabDrug
Also called Ajovy
Fremanezumab (Ajovy®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
GalcanezumabDrug
Also called Emgality
Galcanezumab (Emgality®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
ErenumabDrug
Also called Aimovig
Erenumab (Aimovig®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
Botulinum toxin ADrug
Also called Botox
Botolinum toxin A (Botox) injections into extracranial muscles, dosage at discretion of clinical provider, for treatment of migraines.
| Study group | Role | What they receive |
|---|---|---|
| CGRP inhibitor | * Ubrogepant (Ubrelvy™)
* Rimegepant (Nurtec®)
* Atogepant (Qulipta™)
* Eptinezumab (Vyepti®)
* Fremanezumab (Ajovy®)
* Galcanezumab (Emgality®)
* Erenumab (Aimovig®) dosage and duration according to provider's clinical decision. Receives: Drug: Ubrogepant; Drug: Rimegepant; Drug: Atogepant; Drug: Eptinezumab; Drug: Fremanezumab; Drug: Galcanezumab; Drug: Erenumab | |
| BoNTA extracranial muscle injections | Botolinum toxin A (Botox) Injection into extracranial muscles to treat migraine. Dosage and duration according to provider's clinical decision Receives: Drug: Botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start5 Apr 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Goldman, MD, The Cleveland Clinic
- Investigators
- Howard B Goldman, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212661
- Sponsor's protocol ID
- 23-1101
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Medication Effects on Urinary Symptoms
- ClinicalTrials.gov ID
- NCT06212661
- Acronym / sponsor ID
- 23-1101
- Conditions
- Overactive Bladder, Bladder Pain Syndrome, Migraine Disorders, Overactive Bladder Syndrome, Overactive Detrusor, Migraine
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGRP inhibitor | – | Drug: Ubrogepant, Drug: Rimegepant, Drug: Atogepant, Drug: Eptinezumab, Drug: Fremanezumab, Drug: Galcanezumab, Drug: Erenumab* Ubrogepant (Ubrelvy™) * Rimegepant (Nurtec®) * Atogepant (Qulipta™) * Eptinezumab (Vyepti®) * Fremanezumab (Ajovy®) * Galcanezumab (Emgality®) * Erenumab (Aimovig®) dosage and duration according to provider's clinical decision. |
| BoNTA extracranial muscle injections | – | Drug: Botulinum toxin ABotolinum toxin A (Botox) Injection into extracranial muscles to treat migraine. Dosage and duration according to provider's clinical decision |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Female Patients > 18 years
- Refractory migraine, planned treatment with either:
- CGRP inhibitors, including:
- BoNTA extracranial muscle injections
- Any of the following symptoms during the last month:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UbrogepantAlso: UbrelvyUbrogepant (Ubrelvy™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches. | Drug | CGRP inhibitor |
| RimegepantAlso: NurtecRimegepant (Nurtec®), oral, dosage at discretion of clinical provider, for treatment of migraine headaches. | Drug | CGRP inhibitor |
| AtogepantAlso: QuliptaAtogepant (Qulipta™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches. | Drug | CGRP inhibitor |
| EptinezumabAlso: VyeptiEptinezumab (Vyepti®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches. | Drug | CGRP inhibitor |
| FremanezumabAlso: AjovyFremanezumab (Ajovy®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches. | Drug | CGRP inhibitor |
| GalcanezumabAlso: EmgalityGalcanezumab (Emgality®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches. | Drug | CGRP inhibitor |
| ErenumabAlso: AimovigErenumab (Aimovig®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches. | Drug | CGRP inhibitor |
| Botulinum toxin AAlso: BotoxBotolinum toxin A (Botox) injections into extracranial muscles, dosage at discretion of clinical provider, for treatment of migraines. | Drug | BoNTA extracranial muscle injections |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. no plan to share with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Howard B Goldman, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder and Bladder Pain Syndrome, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in OAB symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.