The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents

Urolithiasis Clinical Trial

Official title:

Randomized, Single Center Controlled Trial of the Effect of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents in Patients With Urolithiasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022952
• Other study ID #: Stone_MD_forgotten_stent
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: St. Petersburg State Pavlov Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents

Description:

Inclusion Criteria:

1. Male and female patients aged 18 to 80 years who have a Ch 4.7-6.0 polyurethane ureteral stent

Exclusion Criteria:

1. Active phase of urinary tract infection

2. Insufficient level of social adaptation

3. The patient does not have a smartphone with Internet access

All patients will be randomized into 2 groups:

• group A - patients who used the Stone MD mobile application

• group B - patients who did not use the mobile application Patients are to be assigned a randomization number that will match their treatment. Block randomization using 10 blocks is to be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.

"Stent Radar" - part of the "Stone MD" mobile application. This tool is designed for the patient to remove the ureteral stent using a mobile application within the time period prescribed by the doctor. After the operation, the patient independently enters the data related to the installation of the stent in the Stent Radar section of the Stone MD mobile application. This data includes: the name of the stent, the side of insertion, and the estimated date of removal. In a few days, a push notification appears in the application stating that it is necessary to consult a doctor for the timely removal of the stent. Thus, it is almost impossible to forget to remove the stent.

At discharge, we strongly recommend that all patients install the Stone MD mobile app on their smartphone. In the postoperative period, all patients will be monitored. In the event that 2 weeks after the expected date of removal, the patient does not get in touch, he will receive a call from the clinic, reminding him of the necessary visit (to remove the stent).

Primary assessed outcomes:

1. Number of patients who removed the stent on time in both groups

2. Number of patients who delayed stent removal in both groups (less than 14 days)

3. Number of patients who forgot to remove the stent in both groups (removed the stent more than 14 days from the expected date of removal)

Secondary assessed outcomes:

1. Assessment of Stone-free status after surgery by performing computed tomography of kidneys and urinary tract without intravenous contrasting 1 month after surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male and female patients aged 18 to 80 years who have a Ch 4.7-6.0 polyurethane ureteral stent

Exclusion Criteria:

1. Active phase of urinary tract infection

2. Insufficient level of social adaptation

3. The patient does not have a smartphone with Internet access

Related Conditions & MeSH terms

• Urinary Calculi
• Urolithiasis

Intervention

Other:
• Stone MD stent radar
Mobile app

Locations

Country	Name	City	State
Russian Federation	First Pavlov Saint Petersburg University	Saint Petersburg
Russian Federation	Saint Petersburg State University Hospital	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removed on time	Number of patients who removed the stent on time in both groups	30 days
Primary	Delayed stent removal	Number of patients who delayed stent removal in both groups (less than 14 days)	30 days
Primary	Forgotten stent removal	Number of patients who forgot to remove the stent in both groups (removed the stent more than 14 days from the expected date of removal)	30 days