Air vs. Liquid: A Study on Cystoscopy Performance and Visibility Enhancement in Macrohematuria Cases
Starting soon · Not applicable
Conditions studied: Macrohematuria
In brief
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).
Key facts
- Study ID
- NCT07618221
- Run by
- Kantonsspital Baden
- People needed
- 40
- Starts
- 2026-07-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kantonsspital Baden AG, Department of Urology — Baden, Canton of Aargau, Switzerland
Full record on ClinicalTrials.gov
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