Pilot study of the digital health application Uroli based on the BfArM guideline The Fast Track Procedure for Digital Health Applications (DiGA) according to §139e SGB V.

Not Applicable

• Conditions: N20; Calculus of kidney and ureter

• Registration Number: DRKS00029633
• Lead Sponsor: Medipee GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-26
• Study Completion: 2023-10-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with renal/ureteral stone (ICD-10: N20) who require personalized stone metaphylaxis, regardless of stone type and regardless of initial occurrence or recurrence; individuals 18 years of age and older; regular use of a smartphone, including use of apps to ensure usability of the Uroli app; accessibility via e-mail

Exclusion Criteria

Patients with acute symptoms of urolithiasis; Patients who are medically judged to be limited in fluid intake due to other medical conditions or patients with markedly impaired renal function as defined by a serum creatinine level >2mg/dl; Individuals who have been determined by an investigator to be unable to participate in the study; Individuals under the age of 18; Not owning or regularly using their own smartphone; Not having their own email address; Individuals without consent to participate in the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study Objective:<br>To evaluate the effectiveness of the Uroli app in supporting metaphylaxis of adult patients with urolithiasis after acute treatment of a renal or ureteral stone compared to metaphylaxis without the Uroli app in terms of medical benefit and patient-relevant structural and procedural improvements.<br><br>The individual endpoints defined, including the measurement instruments used for this purpose, can be found in the attached study document ( Endpoints).<br><br>The measurement variables will be collected at T0 and after 3 months (T1).<br><br>Translated with www.DeepL.com/Translator (free version)