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Air vs. Liquid: A Study on Cystoscopy Performance and Visibility Enhancement in Macrohematuria Cases (AIROSCOPY)

31. mai 2026 oppdatert av: Lukas J Hefermehl, Kantonsspital Baden

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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Sveits
    • Canton of Aargau
      • Baden, Canton of Aargau, Sveits, 5404
        • Kantonsspital Baden AG, Department of Urology
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: Air-based flexible cystoscopy
Flexible cystoscopy with manual air insufflation (up to 240 ml) via bladder syringe for bladder distension and visualisation.
Aktiv komparator: 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.
Fremgangsmåte: Saline-based flexible cystoscopy
Flexible cystoscopy with manual saline irrigation (up to 240 ml, 0.9% NaCl) via bladder syringe for bladder distension and visualisation.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Identification of the underlying cause of macroscopic haematuria during the index cystoscopy
Tidsramme: Immediately after completion of the index cystoscopy (intraoperative)
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.
Immediately after completion of the index cystoscopy (intraoperative)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to source identification
Tidsramme: Intraoperative
Minutes from insertion of the cystoscope to first identification of the bleeding source during the index cystoscopy.
Intraoperative
Total procedure duration
Tidsramme: Intraoperative
Minutes from insertion to removal of the cystoscope during the index cystoscopy.
Intraoperative
Urologist-rated visibility
Tidsramme: Immediately after index cystoscopy
5-point Likert scale (1 = very poor to 5 = excellent), completed by the operating urologist immediately after the index cystoscopy.
Immediately after index cystoscopy
Patient comfort
Tidsramme: Immediately after index cystoscopy
Description: 5-point Likert scale (1 = very uncomfortable to 5 = very comfortable), completed by the patient immediately after the index cystoscopy.
Immediately after index cystoscopy

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kantonsspital Baden

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. februar 2028

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

25. mai 2026

Først innsendt som oppfylte QC-kriteriene

25. mai 2026

Først lagt ut (Faktiske)

1. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-00787 (Annen identifikator: EKNZ (Ethikkommission Nordwest- und Zentralschweiz))

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

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