Skip to content

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".

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". - Uroli I

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029633
Enrollment
50
Registered
2022-07-26
Start date
2022-07-08
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

N20

Interventions

Group 1: Study participants in the intervention group will receive access to the Uroli app and the Medipee device with urine test strips for 250 determinations at recruitment and before discharge from

Sponsors

Medipee GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Study Objective: 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. The individual endpoints defined, including the measurement instruments used for this purpose, can be found in the attached study document (" Endpoints"). The measurement variables will be collected at T0 and after 3 months (T1). Translated with www.DeepL.com/Translator (free version)

Countries

Germany

Contacts

Public ContactAlexander Winter

Klinikum Oldenburg, Universitätsklinik für Urologie

winter.alexander@klinikum-oldenburg.de04414032302

Outcome results

None listed

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