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

Phase 3
Recruiting
Conditions
N20
Calculus of kidney and ureter
Registration Number
DRKS00025298
Lead Sponsor
roNova GmbH medizinische Implantate
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
300
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

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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Measurement of the weight of encrustation after 30 days indwelling time
Secondary Outcome Measures
NameTimeMethod
Evaluation of the grade of ureteral stent symptoms 7 days after insertion and 7 days after removal
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