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

• Sponsor: St. Petersburg State Pavlov Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06022952
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 10
• Patients Per Site: 100
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urolithiasis	Other: Stone MD stent radar	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Removed on time [30 days]

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

2. Delayed stent removal [30 days]

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

3. Forgotten stent removal [30 days]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Pavlov Saint Petersburg University	Saint Petersburg		Russian Federation	197342
2	Saint Petersburg State University Hospital	Saint Petersburg		Russian Federation

Sponsors and Collaborators

• St. Petersburg State Pavlov Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Petersburg State Pavlov Medical University
• ClinicalTrials.gov Identifier: NCT06022952
• Other Study ID Numbers: Stone_MD_forgotten_stent
• First Posted: Sep 5, 2023
• Last Update Posted: Sep 5, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urolithiasis; Urinary Calculi

Study Results

No Results Posted as of Sep 5, 2023