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).
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
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
Parallel
Air-based flexible cystoscopy
Procedure/SurgeryFlexible cystoscopy with manual air insufflation (up to 240 ml) via bladder syringe for bladder distension and visualisation.
Saline-based flexible cystoscopy
Procedure/SurgeryFlexible cystoscopy with manual saline irrigation (up to 240 ml, 0.9% NaCl) via bladder syringe for bladder distension and visualisation.
Identification of the underlying cause of macroscopic haematuria during the index cystoscopy
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.
Time to source identification
Minutes from insertion of the cystoscope to first identification of the bleeding source during the index cystoscopy.
Total procedure duration
Minutes from insertion to removal of the cystoscope during the index cystoscopy.
Urologist-rated visibility
5-point Likert scale (1 = very poor to 5 = excellent), completed by the operating urologist immediately after the index cystoscopy.
Patient comfort
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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