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Comparative study of encrustation and bacterial colonization of ureteral stents with anti adhesive and bacteria repelling coating versus uncoated stents

Comparative study of encrustation and bacterial colonization of ureteral stents with anti adhesive and bacteria repelling coating versus uncoated stents - CLEANUS

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025298
Enrollment
300
Registered
2021-10-21
Start date
2022-04-20
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N20

Interventions

Group 1: Uncoated ureteral stent Group 2: Coated ureteral stent

Sponsors

UroNova GmbH medizinische Implantate
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with renal colic that cannot be controlled with medication, severe obstruction with consecutive urinary congestion and / or increasing retention values ??in accordance with the S2k guideline for diagnosis, therapy and metaphylaxis of urolithiasis. After complicated procedures using ureterorenoscopy, in the case of residual fragments or complications that require treatment In the case of Steinstrasse and fever / urinary tract infection (accumulation of stone fragments in the ureter, which do not pass spontaneously and / or block urine transport) Age:> 18 years Written declaration of consent available

Exclusion criteria

Exclusion criteria: Patients for whom a ureteral stent cannot be used due to the anatomical conditions. Insufficient mental, linguistic, or physical ability to participate in the study. ECOG> 3 (Eastern Co-operative of Oncology Group) Refusal to participate in the clinical trial. Planned long-term supply or foreseeable long indwelling time of the ureteral stent (> 30 days). Participation in another clinical trial within the last 30 days. Patients who are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Measurement of the weight of encrustation after 30 days indwelling time

Secondary

MeasureTime frame
Evaluation of the grade of ureteral stent symptoms 7 days after insertion and 7 days after removal

Countries

Germany

Contacts

Public ContactSascha Pahernik

Urological Clinic, Klinikum Nürnberg

urologie@klinikum-nuernberg.de+49 911 3982372

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026