- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04426682
Incontinence Surgery and Urodynamics Parameters
In Patients Who Underwent Incontinence Surgery and Who Had Postoperative Recurrence Comparison of Urodynamics Parameters Performed in Preoperative and Postoperative Period
In patients who have previously had incontinence surgery due to stress incontinence (Midurethral slings (tvt, tot, etc.)), the symptoms may return in the following years and the patient can reapply with urinary incontinence. Urodynamic evaluation is important before stress incontinence surgery to confirm clinical diagnosis based on symptoms and findings and to determine the factors that may affect the effectiveness of surgery and the possibility of complications. Urodynamics evaluation is performed in the preoperative period in patients scheduled for incontinence. Urodynamics evaluation is performed again in patients who applied with post-operative recurrence due to surgery failure or different reasons.
It is aimed to show whether there is a difference between the urodynamics parameters of these patients who were examined preoperatively and the urodynamics parameters examined in case of postoperative failure. Thus, the primary goal; to show which of these parameters has deterioration or if the surgical method is insufficient if it is within certain limits or urinary incontinence may recur.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Istanbul, Peru, 33404
- Kanuni Sultan Suleyman Training and Research Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients who have previously undergone surgery for stress incontinence
- Those who are symptomatic again in their post-operative follow-up (urinary incontinence),
- Patients who underwent preoperative and postoperative urodynamics
Exclusion Criteria:
- Those with chronic diseases or medications that may cause urinary incontinence
- Patients with mixed or urge incontinence
- Patients who are not symptomatic postoperatively
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Controle de caso
- Perspectivas de Tempo: Retrospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
post-operative urinary incontinents
In patients who have previously had incontinence surgery due to stress incontinence, symptoms may return in the following years, and the patient may reapply with urinary incontinence.
The first group will consist of postoperative urinary incontinence recurrent patients.
Patients whose urodynamics are reperformed due to recurrence are the study group.
|
Urodynamics evaluation is performed in the preoperative period in patients whose operation is planned due to incontinence. Urodynamics evaluation is performed again in patients who applied with postoperative relapse due to surgery failure or different reasons. It will be shown whether there is a difference between the urodynamics parameters of preoperatively examined patients and those of urodynamics examined in case of postoperative failure. |
without postoperative urinary incontinence
Patients who previously had incontinence surgery due to stress incontinence and who did not have postopertive urinary incontinence but whose urodynamics were repeated during the routine controls will constitute the control group.
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Urodynamics evaluation is performed in the preoperative period in patients whose operation is planned due to incontinence. Urodynamics evaluation is performed again in patients who applied with postoperative relapse due to surgery failure or different reasons. It will be shown whether there is a difference between the urodynamics parameters of preoperatively examined patients and those of urodynamics examined in case of postoperative failure. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
urodynamics parameters V max
Prazo: 5 YEARS
|
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; V max (voiding speed) cm3
|
5 YEARS
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urodynamics parameters bladder complians
Prazo: 5 YEARS
|
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians
|
5 YEARS
|
urodynamics parameters valsalva leak point pressure
Prazo: 5 YEARS
|
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; valsalva leak point pressure (mmhg)
|
5 YEARS
|
urodynamics parameters abdominal leak point pressure
Prazo: 5 YEARS
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urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; abdominal leak point pressure (mmhg)
|
5 YEARS
|
urodynamics parameters P det
Prazo: 5 YEARS
|
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)
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5 YEARS
|
urodynamics parameters P abd
Prazo: 5 YEARS
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urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P abdominal (P abd) (mmhg)
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5 YEARS
|
urodynamics parameters P urethral
Prazo: 5 YEARS
|
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P urethral (mmhg)
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5 YEARS
|
urodynamics parameters UPP
Prazo: 5 YEARS
|
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; urethral pressure profile (UPP)
|
5 YEARS
|
Colaboradores e Investigadores
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 (Real)
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
Outros números de identificação do estudo
- ATADEK / 2020.06
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