Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Pilot Deprescribing of Antimuscarinic Overactive Bladder Medications in Parkinson Disease

31 de maio de 2026 atualizado por: Allison Willis, Corporal Michael J. Crescenz VA Medical Center

Evaluating the Effect of Deprescribing Antimuscarinic Overactive Bladder Medications on Cognitive Function and Quality of Life of Individuals With Parkinson Disease: A Pharmacist-led Series of N-of-1 Trials

This is an unblinded, non-randomized National Institute of Health (NIH) Stage I of Behavioral Intervention Development trial. The investigators will enroll 20 subjects with Parkinson disease (PD) for a series of 20 of N-of-1 trials. The investigators will use a single-arm crossover titration/reversal design ("ON" [A] vs. "OFF" [B]) with up to 4 periods. All participants will follow the sequence ABAB. Each period will last up to 10 weeks, allowing for sufficient time for up-titration and onset of drug action, and down-titration and washout. Each participant will have the option to participate in less (2-3) or more (3-4) periods depending on whether additional information is needed to make an informed decision about continuing or discontinuing the overactive bladder (OAB) antimuscarinic at the end of the study. The intervention drug will be an OAB antimuscarinic, previously prescribed to the participants by their physician. The investigators will reduce the dose of each OAB antimuscarinic by 25-50% every 1-2 weeks during the "OFF" [B] period, with the goal to completely discontinue the medication.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Corporal Michael J. Crescenz VA Medical Center
        • Contato:
        • Contato:
        • Investigador principal:
          • Allison Willis, MD, MS
        • Subinvestigador:
          • Thanh Phuong Pham Nguyen, PharmD, MBA, MSCE

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. 60+ years old at time of enrollment
  2. Have a diagnosis of Parkinson disease (PD) made by a movement disorders specialist
  3. Life expectancy of at least six months
  4. Are on an antimuscarinic for overactive bladder (OAB) symptoms (without concurrent use of a beta-3 agonist) for at least 3 months
  5. Are able to provide informed consent
  6. Are able to complete online surveys/questionnaires
  7. Are able to receive telephone calls and Zoom calls/telehealth meeting

Exclusion Criteria:

  1. Have untreated or uncontrolled hypertension (blood pressure [BP] ≥180/110 mmHg),
  2. Have active urinary tract infection (UTI) or chronic/recurrent UTI (≥2 UTIs in six months or ≥3 in one year)
  3. Have moderate or severe hepatic impairment (Child-Pugh Score Class B or C)
  4. Have severe renal impairment (Estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.72 m2) or end-stage renal disease (on dialysis or renal replacement therapy)
  5. Have prior history of hypersensitivity or intolerance to mirabegron or vibegron
  6. Have existing cognitive impairment (Montreal Cognitive Assessment [MoCA] score <22/30) or psychiatric disorder that preclude informed consent
  7. Have any other condition that, in Principal Investigator (PI) and Co-PI's opinion, makes the individual unsuitable for study participation
  8. On non-oral form of OAB antimuscarinics, the oral solution formulation of oxybutynin chloride or the oral suspension formulation of solifenacin succinate (due to complicated tapering process)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: AB(AB) arm
All participants will follow a single-arm AB(AB) sequence. During the initial "ON" [A] period, participants will continue their overactive bladder antimuscarinic at their maintenance dose for up to 10 weeks. This will be followed by an "OFF" [B] period of up to 10 weeks, during which the antimuscarinic will be gradually tapered by approximately 25%-50% every 1-2 weeks until the lowest effective dose or complete discontinuation is reached. A second AB sequence may be repeated, if needed.
Medicamento: Overactive bladder antimuscarinic deprescribing
During the "ON" [A] period (up to 10 weeks), the participant will continue taking their overactive bladder antimuscarinic at their maintenance dose. During the "OFF" [B] period (i.e., deprescribing), which will last up to 10 weeks, the antimuscarinic dose will be gradually tapered by 25%-50% every 1-2 weeks until the lowest effective dose or complete discontinuation is achieved. Alternative treatment with mirabegron (pharmacologic) may be initiated, as clinically indicated, if the participant experiences intolerable recurrence of overactive bladder symptoms after discontinuation of the antimuscarinic.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Effects of deprescribing overactive bladder antimuscarinics on cognitive function
Prazo: MoCA scores will be assessed at baseline (Visit 0) and at the completion of the study (Visit 41 or up to 46 weeks from baseline).
The investigators will evaluate the effects of deprescribing overactive bladder (OAB) antimuscarinics in individuals with Parkinson disease (PD) on their cognitive function, as measured by the change in participant's cognitive function using the Montreal Cognitive Assessment (MoCA) when they are "ON" vs. "OFF" antimuscarinics. The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores indicating greater cognitive impairment.
MoCA scores will be assessed at baseline (Visit 0) and at the completion of the study (Visit 41 or up to 46 weeks from baseline).
Effects of deprescribing overactive bladder antimuscarinics on autonomic symptom burden
Prazo: SCOPA-AUT scores will be assessed at baseline (Visit 0) and at the completion of the study (Visit 41 or up to 46 weeks after baseline).
The investigators will evaluate the effects of deprescribing overactive bladder (OAB) antimuscarinics in individuals with Parkinson disease (PD) on autonomic symptom burden, as measured by the change in participant's Scales for Outcomes in Parkinson's - autonomic (SCOPA-AUT) when they are "ON" vs. "OFF" antimuscarinics. SCOPA-AUT total score ranges from 0 to 69, with higher scores indicating greater autonomic symptom burden and worse autonomic dysfunction.
SCOPA-AUT scores will be assessed at baseline (Visit 0) and at the completion of the study (Visit 41 or up to 46 weeks after baseline).
Effects of deprescribing overactive bladder antimuscarinics on quality of life
Prazo: QOL will be assessed at will be made at baseline (visit 0) and at the completion of the study (Visit 41 or up to 46 weeks from baseline).
The investigators will evaluate the effects of deprescribing overactive bladder (OAB) antimuscarinics in individuals with Parkinson disease (PD) on participant's quality of life (QOL), as measured by the change in participant's global impression of change using participant's QOL questionnaires when they are "ON" vs. "OFF" antimuscarinics. The baseline and end-of-study QOL questionnaires include questions about participant's current overall QOL (0=very poor, 1=poor, 2=fair, 3=good, 4=very good), current bladder-related QOL (0=very poor, 1=poor, 2=fair, 3=good, 4=very good), and current overall well-being affected by side effects of antimuscarinics (0=extremely, 1=quite a bit, 2=moderately, 3=a little, 4=not at all, 5=not applicable). The end-of-study QOL questionnaire include a question about overall state of health since the start of the study (0=very much worse, 1=minimally worse, 2=no change, 3=minimally improved, 4=very much improved). Higher scores indicate better QOL.
QOL will be assessed at will be made at baseline (visit 0) and at the completion of the study (Visit 41 or up to 46 weeks from baseline).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Features of a feasible and pragmatic protocol for deprescribing N-of-1 trials
Prazo: These elements will be estimated at the conclusion of the study, once all participants have completed study participation (after Visit 41 or after week 46 from baseline).
Feasibility and pragmatic features of a deprescribing N-of-1 trial protocol for older adults with Parkinson disease (PD) receiving chronic overactive bladder (OAB) antimuscarinics in a neurology specialty center will be evaluated using measures including, but not limited to, enrollment rate (participants enrolled/participants approached), retention rate (participants retained through study completion/participants enrolled), study adherence (participants attending 100% of scheduled visits and completing at least 90% of required assessments during the study period/participants enrolled), and time to study completion (weeks from enrollment to trial completion).
These elements will be estimated at the conclusion of the study, once all participants have completed study participation (after Visit 41 or after week 46 from baseline).
Associations between participant and health system characteristics and attitudes toward deprescribing (i.e., satisfaction with current medications)
Prazo: At baseline (Visit 0) and at the completion of the study (Visit 41 or up to week 46 after baseline)
The investigators will explore the association between participant and health system characteristics and their satisfaction with current medication as measured by the Revised Patient Attitudes toward Deprescribing (rPATD) Questionnaire, when possible. The rPATD reports attitudes across 4 domains (burden, appropriateness, concerns about stopping, and involvement), and 2 global questions evaluating satisfaction with current medications and willingness to stop medication(s) if recommended by a physician. Scores range from 0-4, and higher scores indicate stronger agreement with the construct (e.g., greater perceived medication burden, stronger belief in medication inappropriateness, greater concerns about stopping, or greater desire for involvement, greater satisfaction with current medications and greater willingness to stop). The investigators will use participant's answer on satisfaction with current medications for this association.
At baseline (Visit 0) and at the completion of the study (Visit 41 or up to week 46 after baseline)
Associations between participant and health system characteristics and attitudes toward deprescribing (i.e., willingness to deprescribe)
Prazo: At baseline (Visit 0) and at the completion of the study (Visit 41 or up to week 46 after baseline)
The investigators will explore the association between participant and health system characteristics and their willingness to deprescribe as measured by the Revised Patient Attitudes toward Deprescribing (rPATD) Questionnaire, when possible. The rPATD reports attitudes across 4 domains (burden, appropriateness, concerns about stopping, and involvement), and 2 global questions evaluating satisfaction with current medications and willingness to stop medication(s) if recommended by a physician. Scores range from 0-4, and higher scores indicate stronger agreement with the construct (e.g., greater perceived medication burden, stronger belief in medication inappropriateness, greater concerns about stopping, or greater desire for involvement, greater satisfaction with current medications and greater willingness to stop). The investigators will use participant's answer on willingness to deprescribe for this association.
At baseline (Visit 0) and at the completion of the study (Visit 41 or up to week 46 after baseline)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Corporal Michael J. Crescenz VA Medical Center

Colaboradores

National Institute on Aging (NIA)

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de abril de 2027

Conclusão do estudo (Estimado)

1 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de maio de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1889946-4
  • R33AG086944 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever