The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents
Primary Purpose
Urolithiasis
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Stone MD stent radar
Sponsored by
About this trial
This is an interventional prevention trial for Urolithiasis
Eligibility Criteria
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: Active phase of urinary tract infection Insufficient level of social adaptation The patient does not have a smartphone with Internet access
Sites / Locations
- First Pavlov Saint Petersburg UniversityRecruiting
- Saint Petersburg State University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Patients who have used the Stone MD mobile app
Patients who have not used the Stone MD mobile app
Outcomes
Primary Outcome Measures
Removed on time
Number of patients who removed the stent on time in both groups
Delayed stent removal
Number of patients who delayed stent removal in both groups (less than 14 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)
Secondary Outcome Measures
Full Information
NCT ID
NCT06022952
First Posted
August 28, 2023
Last Updated
August 28, 2023
Sponsor
St. Petersburg State Pavlov Medical University
1. Study Identification
Unique Protocol Identification Number
NCT06022952
Brief Title
The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Petersburg State Pavlov Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents
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:
Active phase of urinary tract infection
Insufficient level of social adaptation
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:
Number of patients who removed the stent on time in both groups
Number of patients who delayed stent removal in both groups (less than 14 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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Patients who have used the Stone MD mobile app
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients who have not used the Stone MD mobile app
Intervention Type
Other
Intervention Name(s)
Stone MD stent radar
Intervention Description
Mobile app
Primary Outcome Measure Information:
Title
Removed on time
Description
Number of patients who removed the stent on time in both groups
Time Frame
30 days
Title
Delayed stent removal
Description
Number of patients who delayed stent removal in both groups (less than 14 days)
Time Frame
30 days
Title
Forgotten stent removal
Description
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)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Active phase of urinary tract infection
Insufficient level of social adaptation
The patient does not have a smartphone with Internet access
Facility Information:
Facility Name
First Pavlov Saint Petersburg University
City
Saint Petersburg
ZIP/Postal Code
197342
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitriy Gorelov, MD
Phone
+79217964892
Email
dsgorelov@mail.ru
Facility Name
Saint Petersburg State University Hospital
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nariman Gadzhiev, MD
Phone
+79214311436
Email
nariman.gadjiev@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents
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