Migraine Medication Effects on Urinary Symptoms
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- changes in OAB symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Rimegepant (Drug)
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.
干预措施: Ubrogepant (Drug)
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.
干预措施: Atogepant (Drug)
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.
干预措施: Eptinezumab (Drug)
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.
干预措施: Fremanezumab (Drug)
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.
干预措施: Galcanezumab (Drug)
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.
干预措施: Erenumab (Drug)
BoNTA extracranial muscle injections
Botolinum toxin A (Botox) Injection into extracranial muscles to treat migraine. Dosage and duration according to provider's clinical decision
干预措施: Botulinum toxin A (Drug)
结局指标
主要结局
changes in OAB symptoms
时间窗: 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.
次要结局
- changes in bladder pain symptoms(3 months)
- rates of LUTS and LUTS-related quality of life (QoL) in patients with chronic refractory migraine.(3 months)
研究者
Howard Goldman, MD
Principal investigator / Professor and Vice Chair (Quality and Patient Safety) Glickman Urologic and Kidney Institute
The Cleveland Clinic