Air vs. Liquid: A Study on Cystoscopy Performance and Visibility Enhancement in Macrohematuria Cases (AIROSCOPY)
AIROSCOPY - A Prospective, Randomized, Controlled, Single-Centre Superiority Study Comparing Air-Based Versus Saline-Based Flexible Cystoscopy for the Identification of the Bleeding Source in Patients With Macroscopic Haematuria
Macroscopic haematuria is a common urological emergency. Diagnostic cystoscopy is the gold standard for identifying the bleeding source; however, blood and clots within the bladder significantly impair endoscopic visibility when saline is used as the distension medium.
Air-based cystoscopy, a technique first described in the 19th century, exploits the immiscibility of gas and blood to maintain clear visualisation even during active bleeding. Despite its theoretical advantages, no randomised clinical data exist to support its use.
AIROSCOPY is a prospective, randomised, controlled, single-centre superiority study comparing air-based versus saline-based flexible cystoscopy in patients with macroscopic haematuria (Grade III-V). Patients are randomised 1:1. Only the index cystoscopy (first randomised modality) contributes to all study endpoints. A second cystoscopy with the alternative modality is performed solely for patient safety to ensure no diagnostic disadvantage from study participation. This second examination is not analysed.
The primary endpoint is identification of the bleeding source during the index cystoscopy (binary: yes/no). Secondary endpoints include time to source identification, total procedure duration, urologist-rated visibility (Likert scale), and patient comfort (Likert scale).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background: Continuous bladder irrigation (CBI) is the current standard management for haematuria, but can delay diagnostic cystoscopy. Gas-based cystoscopy may allow earlier and clearer visualisation of the bladder mucosa.
Design: Prospective, randomised (1:1), controlled, parallel-group, open-label, single-centre superiority trial. Randomisation is stratified by haematuria grade and history of transurethral resection (TUR-B/P), using REDCap.
Intervention: Index cystoscopy with either air (up to 240 ml by syringe) or saline (up to 240 ml by syringe), according to randomisation. A second cystoscopy with the alternative medium follows immediately, exclusively to ensure no diagnostic disadvantage for the patient (results not analysed).
Sample size: N=40 (20 per arm), based on detection rates of 86% (air) vs. 38% (saline), two-sided α=0.05, 80% power, with 20% attrition allowance.
Statistics: Chi-square test (Fisher's exact test) for the primary endpoint; risk ratio and risk difference with 95% CI reported.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Lasse Petersen, Dr. med. univ.
- Número de telefone: +41 56 486 3083
- E-mail: lasse.petersen@ksb.ch
Locais de estudo
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Canton of Aargau
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Baden, Canton of Aargau, Suíça, 5404
- Kantonsspital Baden AG, Department of Urology
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Contato:
- Lasse Petersen, Dr.med. univ.
- Número de telefone: 0041 56 486 3083
- E-mail: lasse.petersen@ksb.ch
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Persistent macroscopic haematuria Grade III-V within 48 hours after hospitalisation
- Age ≥ 18 years
- Unexplained macroscopic haematuria requiring diagnostic cystoscopy
- Ability to give written informed consent
Exclusion Criteria:
- Pregnant or lactating women
- Haemodynamic instability or urgent need for operative or interventional cystoscopy (requiring cystoscopy within < 24 hours of screening)
- Ureteral stent in situ
- Active urinary tract infection
- Transurethral resection of the bladder (TURB) or prostate (TURP) within the last 6 weeks
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Air Cystoscopy
Flexible cystoscopy using air as the distension medium (up to 240 ml, manually administered via bladder syringe).
This is the index cystoscopy for patients randomised to air.
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Flexible cystoscopy with manual air insufflation (up to 240 ml) via bladder syringe for bladder distension and visualisation.
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Comparador Ativo: Saline Cystoscopy
Flexible cystoscopy using 0.9% saline as the distension medium (up to 240 ml, manually administered via bladder syringe).
Standard-of-care procedure.
This is the index cystoscopy for patients randomised to saline.
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Flexible cystoscopy with manual saline irrigation (up to 240 ml, 0.9% NaCl) via bladder syringe for bladder distension and visualisation.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Identification of the underlying cause of macroscopic haematuria during the index cystoscopy
Prazo: Immediately after completion of the index cystoscopy (intraoperative)
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Binary outcome (yes/no).
Assessed in real time by the operating urologist during the index procedure and documented immediately after completion.
'Yes' if a specific bleeding source (e.g., tumour, prostate bleeding, stone, vascular lesion) is identified; 'No' otherwise.
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Immediately after completion of the index cystoscopy (intraoperative)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to source identification
Prazo: Intraoperative
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Minutes from insertion of the cystoscope to first identification of the bleeding source during the index cystoscopy.
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Intraoperative
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Total procedure duration
Prazo: Intraoperative
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Minutes from insertion to removal of the cystoscope during the index cystoscopy.
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Intraoperative
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Urologist-rated visibility
Prazo: Immediately after index cystoscopy
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5-point Likert scale (1 = very poor to 5 = excellent), completed by the operating urologist immediately after the index cystoscopy.
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Immediately after index cystoscopy
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Patient comfort
Prazo: Immediately after index cystoscopy
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Description: 5-point Likert scale (1 = very uncomfortable to 5 = very comfortable), completed by the patient immediately after the index cystoscopy.
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Immediately after index cystoscopy
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-00787 (Outro identificador: EKNZ (Ethikkommission Nordwest- und Zentralschweiz))
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