Clinical trial NCT06022952: 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
Overall status: RECRUITING
Phase: NA
Conditions: Urolithiasis
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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

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:

1. Active phase of urinary tract infection
2. Insufficient level of social adaptation
3. The patient does not have a smartphone with Internet access

Primary outcomes:
measure: Removed on time
timeFrame: 30 days
measure: Delayed stent removal
timeFrame: 30 days
measure: Forgotten stent removal
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: First Pavlov Saint Petersburg University
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State University Hospital
Study officials:
References: