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Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder

29 de maio de 2013 atualizado por: KYU-SUNG LEE, Samsung Medical Center

Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder (Phase Ⅳ)

For many years, antimuscarinics have been first-line pharmacological treatment for OAB. A recent meta-analysis of randomised, controlled trials on antimuscarinic treatment of OAB concluded that the drugs provide significant improvements in OAB symptoms compared with placebo but that the benefits are of limited clinical significance. The analysis questioned the clinical significance of the trial results, one reason for which was the lack of data on the use of sensitive patient-driven criteria. Traditional symptomatic and urodynamic measures of treatment success may be meaningful to clinicians but often have little meaning to patients. Therefore, patient-reported outcomes (PROs), which provide a subjective measure of a patient's response to treatment, are useful. Recently, clinicians treating OAB have begun to recognize the value of PROs but still overlook the treatment efficacy in terms of patient-reported goal achievement (PGA).

Patients with OAB have combination of symptoms and the extent to which individual OAB symptoms affect patients varies. Also each patient can have different goal for the treatment. Therefore, assessing the degree of goal achievement in each patient can provide a new aspect of treatment benefit.

This controlled study will advance the understanding of OAB in terms of patient-centered treatments goals and goal achievement and will provide a new aspect of treatment benefit.

Visão geral do estudo

Descrição detalhada

  1. Objectives

    1. Primary objective: To explore the "Patient-reported Goal Attainment (PGA)" after 12 weeks of treatment with tolterodine extended-release (ER) 4mg in female overactive bladder (OAB) patients.
    2. Secondary objective: To explore the patient-reported treatment goals and the efficacy of tolterodine on the patient-reported outcomes (PROs), micturition diary parameters, and safety parameters from baseline to 12 weeks of treatment in female OAB patients.
  2. Specific aim

    : To compare the efficacy of tolterodine ER 4mg with that of placebo, on PROs in terms of PGA after 12 weeks of treatment in female OAB patients.

  3. Experimental/research design

    1. 12-week randomized, placebo-controlled, double-blind, parallel-group, prospective study in Korean women with symptoms of OAB
    2. Treatment: Each patient will receive tolterodine ER (4 mg, qd) or placebo (randomized in the ratio of 1:1) for 12 weeks.
    3. Time schedule Start date: 01/Jan/2009 Finish date: 01/Sep/2009 Duration of washout: 7 days Duration of run-in: 7 days Duration of enrollment period: 5 months Duration of treatment period: 12 weeks Completion of analysis: 6 weeks

Tipo de estudo

Intervencional

Inscrição (Real)

56

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.

Locais de estudo

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

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  1. Female aged ≥ 18 and ≤ 80 years
  2. Symptoms of OAB as verified by the screening 3 day micturition diary, defined by:

    Mean urinary frequency ≥8 times/24 hours Mean number of urgency episodes ≥ 2 episode/24 hours

  3. Symptoms of OAB for ≥ 3 months.
  4. Ability and willingness to correctly complete the micturition diary and questionnaire
  5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

  1. Subjects with stress incontinence or mixed stress/urge incontinence where stress incontinence is the predominant component based on prior history.
  2. Significant hepatic or renal disease, defined as having twice the upper limit of the reference range for serum concentrations of aspartate amino- transferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine.
  3. Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
  4. Symptomatic acute urinary tract infection (UTI) during the run-in period
  5. Recurrent UTI defined as having been treated for symptomatic UTI > 4 times in the last year
  6. Diagnosed or suspected interstitial cystitis
  7. Clinically significant bladder outlet obstruction or poor detrusor function defined by clinical symptoms and investigator's opinion according to local standard of care
  8. Previous history of major urethral and/or bladder surgery
  9. History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason.
  10. Subjects with neuropathology that could affect the lower urinary tract or nerve supply
  11. Patients with marked cystocele or other clinically significant pelvic prolapse.
  12. Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer
  13. Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with: Any anticholinergic drugs other than trial drug Any drug treatment for overactive bladder
  14. On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
  15. Subjects currently taking tricyclic antidepressants, diuretics or alpha blockers who have not been on a stable dose of these medications for at least one month
  16. Current administration of a selective serotonin reuptake inhibitor (SSRI) and has not been on a stable dose for at least three months
  17. Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study
  18. An indwelling catheter or practicing intermittent self-catheterization
  19. Use of any investigational drug within 1 months preceding the start of the study
  20. Patients with chronic constipation or history of severe constipation
  21. Pregnant or nursing women
  22. Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study start and not agreeing to use such methods during the entire study period and for at least 1 month thereafter *Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy).
  23. Any other condition which makes the patient unsuitable for inclusion.

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: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Placebo uma vez ao dia
Identical Placebo once daily
Experimental: Tolterodine ER
Tolterodine ER 4mg once daily
Tolterodine extended-release (ER) 4mg once daily for 12 weeks
Outros nomes:
  • Detrusitol ER 4mg

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Percentage of goal attainment using visual analog scale (VAS) at visit 3 and 4
Prazo: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)

Medidas de resultados secundários

Medida de resultado
Prazo
Assessment of patient-reported treatment goal
Prazo: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks)
Patient-reported outcomes
Prazo: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
Micturition diary efficacy parameters
Prazo: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
Safety parameters
Prazo: visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),
visit 3 (treatment 4 weeks) and 4 (treatment 12 weeks),

Colaboradores e Investigadores

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

Patrocinador

Colaboradores

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

1 de fevereiro de 2009

Conclusão Primária (Real)

1 de janeiro de 2012

Conclusão do estudo (Real)

1 de janeiro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

2 de fevereiro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de fevereiro de 2009

Primeira postagem (Estimativa)

4 de fevereiro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

30 de maio de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de maio de 2013

Última verificação

1 de maio de 2013

Mais Informações

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 .

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