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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lasse Petersen, Dr. med. univ.
- Número de teléfono: +41 56 486 3083
- Correo electrónico: lasse.petersen@ksb.ch
Ubicaciones de estudio
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Canton of Aargau
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Baden, Canton of Aargau, Suiza, 5404
- Kantonsspital Baden AG, Department of Urology
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Contacto:
- Lasse Petersen, Dr.med. univ.
- Número de teléfono: 0041 56 486 3083
- Correo electrónico: lasse.petersen@ksb.ch
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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 activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Identification of the underlying cause of macroscopic haematuria during the index cystoscopy
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to source identification
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Trastornos de la micción
- Hemorragia
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la vejiga urinaria
- Hematuria
Otros números de identificación del estudio
- 2026-00787 (Otro identificador: EKNZ (Ethikkommission Nordwest- und Zentralschweiz))
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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