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

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

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

Study Overview

• Status: Recruiting
• Conditions: Urolithiasis
• Intervention / Treatment: Other: Stone MD stent radar

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • Recruiting
    • Saint Petersburg State University Hospital
    • Contact: Nariman Gadzhiev, MD; Phone Number: +79214311436; Email: nariman.gadjiev@gmail.com
  • Saint Petersburg, Russian Federation, 197342
    • Recruiting
    • First Pavlov Saint Petersburg University
    • Contact: Dmitriy Gorelov, MD; Phone Number: +79217964892; Email: dsgorelov@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Patients who have used the Stone MD mobile app	Other: Stone MD stent radar; Mobile app
Active Comparator: Group B; Patients who have not used the Stone MD mobile app	Other: Stone MD stent radar; Mobile app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Removed on time	Number of patients who removed the stent on time in both groups	30 days
Delayed stent removal	Number of patients who delayed stent removal in both groups (less than 14 days)	30 days
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

Collaborators and Investigators

• Sponsor: St. Petersburg State Pavlov Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: Stone_MD_forgotten_stent

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No