Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
行为疗法或索利那新疗法治疗帕金森病泌尿系统症状
基本信息
- 批准号:10063075
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-04-01 至 2022-03-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAdultAgeAnti-CholinergicsAntiparkinson AgentsAreaBehavior TherapyBehavioralBenchmarkingBladderBladder ControlBradykinesiaBrainCNS processingCaregiver BurdenCaringClinicalCognitiveConsultationsDiseaseEquilibriumEvaluationExerciseExercise TherapyFrequenciesFunctional ImagingFutureGenderGeneral PopulationGlareGoalsHealthHealthcareImpaired cognitionImpairmentIncontinenceIndividualInstitutionalizationInternationalInterventionLeadLearningMeasuresModelingMotor SkillsMuscle ContractionNervous System controlNeuraxisNeurodegenerative DisordersNeuronal PlasticityNeuropsychologyNocturiaOutcomeOutcome MeasureOveractive BladderParkinson DiseaseParticipantPatientsPelvic Floor MusclePersonal SatisfactionPersonsPharmaceutical PreparationsPharmacotherapyPhysical FunctionPhysical MedicinePopulationPrevalenceQuestionnairesRandomizedRandomized Controlled TrialsRehabilitation therapyResearchRisk FactorsSeveritiesSignal TransductionSiteSpouse CaregiverStructureSymptomsTimeTrainingTremorUnited StatesUrge IncontinenceUrinary IncontinenceVeteransVoiceWomanafferent nerveassociated symptombasebehavioral studyburden of illnesscognitive functioncommon symptomcomparative effectivenesscompare effectivenessdesigndisabilityevidence baseexecutive functionfallsimprovedmenmicturition urgencymortalitymotor disordermotor skill learningmotor symptomneuromechanismnon-motor symptomnovel strategiespatient safetyprimary outcomereduce symptomsresearch and developmentresponsesensory inputtreatment guidelinestreatment optimizationtreatment responseurinary
项目摘要
The number of persons with Parkinson Disease (PD) in the United States is expected to double by 2030 as the
population ages. Importantly, this increase in the prevalence of PD will have greater impact within the
Department of Veterans Affairs (VA) because the Veteran population is older than the general population and
Veterans with PD are more likely than those without PD to rely solely on VA for their health care. While PD is
often characterized by the motor symptoms of the disease (tremor, bradykinesia, rigidity), non-motor symptoms
such as urinary symptoms correlate more closely with impaired well-being as the disease progresses.
However, the impact of urinary symptoms in PD extends beyond worsened well-being. The urinary symptoms
of overactive bladder (OAB), including urgency, frequency, and nocturia, with or without urinary incontinence,
are the most common urinary symptoms of PD. OAB symptoms are associated with falls (a cause of
increased mortality in PD), with spouse/caregiver stress, and, ultimately with institutionalization, thus it is
critical that we optimize the care of urinary symptoms for Veterans with PD.
Several studies suggest abnormal central nervous system processing of sensory input from bladder
afferent nerves contributes to OAB symptoms in PD, possibly because of delayed recognition of bladder
fullness. This mirrors findings in non-PD populations with OAB. In the non-PD OAB population, pelvic floor
muscle contractions diminish bladder muscle contraction and recent evidence demonstrates that behavioral
training with pelvic floor muscle exercises improves the cortical integration of bladder afferent signals. Pelvic
floor muscle exercise-based behavioral therapy for OAB symptoms requires individuals to learn a motor skill
and implement an adaptive behavioral strategy to delay the need to void. Because of its effectiveness
compared to drug therapy, pelvic floor muscle exercise-based behavioral therapy is recommended first-line in
men and women with OAB who do not have PD. However, the most recent clinical guidelines for the treatment
of urinary symptoms in PD recommend treatment with anticholinergic drugs. While some anticholinergic drugs
are effective in reducing symptoms of OAB, it is important to note that there is a glaring lack of an empirical
evidence base to promote these drugs in the setting of PD given that they add to the anticholinergic burden of
antiparkinsonian therapy, and may worsen the cognitive and autonomic burdens of the illness. Therefore,
randomized controlled trials (RCTs) are needed to optimize treatment paradigms for urinary symptoms in PD.
We propose a three-site, RCT conducted at the Atlanta (lead site), Birmingham and Richmond VA's to
establish non-inferiority of pelvic floor muscle exercise-based behavioral therapy compared to drug therapy for
OAB symptoms in adults with PD. Groups will be stratified by OAB symptom severity, PD motor symptom
severity, gender, and site. We will randomize 90 participants in order to complete the study in 80 participants,
assuming 85% power and a non-inferiority margin for the OAB symptom score of 15% at 12-weeks. The
primary outcome measure will be urinary symptom severity as measured by the International Consultation on
Incontinence Questionnaire(ICIQ)-OAB symptom score collected at 3 time points during the study: baseline, 6
weeks, and 12 weeks. Our benchmark for successful treatment will be a ≥ 2 point reduction in the ICIQ-OAB
symptom score, which corresponds with perceived benefit in preliminary studies of behavioral therapy
treatment for OAB symptoms in PD. To evaluate the primary efficacy outcome, we will utilize a random effects
mixed model and adjust for baseline OAB symptom score severity. Additionally, in order to better understand
central control mechanisms of bladder function, we will determine if domain-specific cognitive function impacts
the response to exercise-based behavioral therapy or drug therapy for urinary symptoms. At baseline and 12
weeks, randomized participants will undergo a brief neuropsychological battery. Understanding how domain-
specific cognitive function impacts response to treatment may inform new targets for rehabilitation therapy.
预计到2030年,美国帕金森病(PD)患者的数量将翻一番,因为
人口老龄化。重要的是,帕金森病患病率的增加将在
退伍军人事务部(VA),因为退伍军人人口比普通人口年龄更大,
患有帕金森病的退伍军人比没有帕金森病的退伍军人更有可能完全依赖退伍军人管理局的医疗保健。而PD则是
通常以疾病的运动症状(震颤、运动迟缓、僵硬)、非运动症状为特征
例如,随着疾病的发展,尿路症状与受损的幸福感更密切相关。
然而,帕金森病患者的尿路症状的影响远远超出了恶化的幸福感。尿路症状
膀胱过度活动症(OAB),包括尿急、尿频和夜尿,伴或不伴尿失禁,
是帕金森病最常见的尿路症状。OAB症状与跌倒(跌倒的原因之一)有关
帕金森病死亡率增加),配偶/照顾者压力,最终与制度化,因此
关键是我们要优化帕金森病退伍军人的尿路症状护理。
几项研究表明,来自膀胱的感觉输入的中枢神经系统异常处理
传入神经参与了帕金森病患者的OAB症状,可能是因为对膀胱的延迟识别
丰满。这反映了在患有OAB的非PD人群中的发现。在非帕金森病OAB人群中,盆底
肌肉收缩减少了膀胱肌肉的收缩,最近的证据表明,行为
配合盆底肌肉训练可改善膀胱传入信号的皮质整合。骨盆
针对OAB症状的基于地板肌肉锻炼的行为疗法要求个人学习运动技能
并实施一种适应性行为策略,以推迟作废的需要。因为它的有效性
与药物疗法相比,以盆底肌肉锻炼为基础的行为疗法被推荐为
患有OAB但没有帕金森病的男性和女性。然而,最新的临床治疗指南
有尿路症状的帕金森病患者建议使用抗胆碱能药物治疗。而一些抗胆碱能药物
在减少OAB症状方面是有效的,但重要的是要注意到,明显缺乏经验
在帕金森病背景下推广这些药物的证据基础,因为它们增加了
抗帕金森症治疗,并可能加重疾病的认知和自主神经负担。因此,
需要随机对照试验(RCT)来优化PD患者尿路症状的治疗方案。
我们建议在亚特兰大(牵头地点)、伯明翰和里士满进行三个地点的RCT,以
建立以盆底肌肉锻炼为基础的行为疗法与药物疗法的非劣势
成人帕金森病患者的OAB症状。将按OAB症状严重程度、PD运动症状
严重程度、性别和地点。我们将随机抽取90名参与者,以便在80名参与者中完成研究,
假设能量为85%,12周时OAB症状评分为15%,非自卑边际。这个
主要结果衡量标准将是由国际尿路疾病咨询委员会衡量的尿路症状严重程度。
大小便失禁问卷(ICIQ)-在研究过程中的3个时间点收集的OAB症状评分:基线,6
几周,还有12周。我们成功治疗的基准将是ICIQ-OAB的≥降低2个百分点
症状评分,与行为疗法初步研究中感知到的益处相对应
帕金森病患者OAB症状的治疗。为了评估初步疗效结果,我们将利用随机效应
混合模型,并根据基线OAB症状评分严重程度进行调整。此外,为了更好地了解
膀胱功能的中枢控制机制,我们将确定特定领域的认知功能是否会影响
对以运动为基础的行为疗法或药物疗法治疗泌尿症状的反应。在基线和12
几周后,随机分组的参与者将接受短暂的神经心理测试。了解领域如何-
特定的认知功能对治疗反应的影响可能为康复治疗提供新的靶点。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Elizabeth Camille Vaughan其他文献
Elizabeth Camille Vaughan的其他文献
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{{ truncateString('Elizabeth Camille Vaughan', 18)}}的其他基金
Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
行为疗法或索利那新疗法治疗帕金森病泌尿系统症状
- 批准号:
10623149 - 财政年份:2018
- 资助金额:
-- - 项目类别:
Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
行为疗法或索利那新疗法治疗帕金森病泌尿系统症状
- 批准号:
10385702 - 财政年份:2018
- 资助金额:
-- - 项目类别:
Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
行为疗法或索利那新疗法治疗帕金森病泌尿系统症状
- 批准号:
9648034 - 财政年份:2018
- 资助金额:
-- - 项目类别:
Behavioral therapy to treat urinary symptoms in Parkinson's disease
行为疗法治疗帕金森病的泌尿系统症状
- 批准号:
8201976 - 财政年份:2012
- 资助金额:
-- - 项目类别:
Behavioral therapy to treat urinary symptoms in Parkinson's disease
行为疗法治疗帕金森病的泌尿系统症状
- 批准号:
8838206 - 财政年份:2012
- 资助金额:
-- - 项目类别:
Behavioral therapy to treat urinary symptoms in Parkinson's disease
行为疗法治疗帕金森病的泌尿系统症状
- 批准号:
8424826 - 财政年份:2012
- 资助金额:
-- - 项目类别:
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