- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00971646
Cohort Study: Perceptual Urge Sensation
Over the past few years it has become clear that our understanding of bladder physiology is inadequate to explain urge incontinence. This has forced us to re-evaluate what we know and do not know about bladder function and dysfunction. This has led to the identification and study of novel systems within the bladder that may contribute to abnormal sensations.
The investigators now suspect that the organic changes occurring in the bladder are not the whole story. For one group of patients with pathological urge there is growing evidence suggesting that there may be a strong psychological component. The idea now being put forward is that normal afferent peripheral information is perceived as abnormal and excessive, resulting in an increased desire to go to the bathroom: 'perceptual urge'. It is important to identify this group of patients since it will direct their treatment towards more cognitive approaches. Also, if such a psychological aetiology can be eliminated it would lead to a more focused and effective management of peripheral pathology with surgery or pharmacology.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Limburg
-
Maastricht, Limburg, Holanda, 6202 AZ
- Maastricht University Medical Centre
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The study population consists of two groups: 1: patients with OAB; 2: patients with osteoporosis.
The patients with OAB will be reqruited from the outpatient clinic and website designed for patients with overactive bladder symptoms.
The patients with osteoporosis will be recruited from an electronic patient database.
Descrição
Inclusion Criteria (for patients with OAB):
- Patients older than 18 years with OAB diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days of these three days they keep a micturation diary with a VAS score for urge sensation.
Patients should have at least one episode of urge: sudden compelling desire to void which can not be postponed.
- Well versed in Dutch.
Inclusion Criteria (for patients with osteoporosis):
- Patients older than 18 years with osteoporosis joined into the Fast Guide cohort program.
- Well versed in Dutch.
Exclusion Criteria (for patients with OAB):
- Patients with stress-urinary incontinence
- Presence of post void residual urine > 100cc determined by ultrasound
- Presence of urinary tract infection, determined by urine sticks. Patients with urinary tract infection will be treated by antibiotics. After resolution of the infection, the patient can re-enter the study if the urine is sterile at that moment.
Exclusion Criteria (for patients with osteoporosis):
- Urinary complaints or urologic history
- Presence of postvoid residual urine > 100cc determined by ultrasound
- Presence of urinary tract infection, determined by urine sticks. Patients that present with urinary tract infection will be definitively excluded from participation.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
OAB
Patients with overactive bladder syndrome
|
On the micturition diary patients are asked to note every void and drink.
With every void they are asked to estimate their bladder volume and grade their degree of desire to void.
This questionnaire is designed to screen for the presence of a mood disorder.
This questionnaire grades the health condition of the subject.
The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.
|
|
Osteoporosis
Patients with osteoporosis
|
On the micturition diary patients are asked to note every void and drink.
With every void they are asked to estimate their bladder volume and grade their degree of desire to void.
This questionnaire is designed to screen for the presence of a mood disorder.
This questionnaire grades the health condition of the subject.
The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Defining differences in self-consciousness and HADS scores in patients with OAB
Prazo: 1 year
|
1 year
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Defining differences between self-consciousness and HADS scores between the two cohorts
Prazo: 1 year
|
1 year
|
|
Defining differences in quality of life between the two cohorts
Prazo: 1 year
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Gommert van Koeveringe, MD, PhD, urologist, Maastricht University Medical Centre
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 09-1234567
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 .