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

NCT ID: NCT06022952

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-12-01

Brief Summary

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

Detailed Description

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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

Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Patients who have used the Stone MD mobile app

Group Type ACTIVE_COMPARATOR

Stone MD stent radar

Intervention Type OTHER

Mobile app

Group B

Patients who have not used the Stone MD mobile app

Group Type ACTIVE_COMPARATOR

Stone MD stent radar

Intervention Type OTHER

Mobile app

Interventions

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Stone MD stent radar

Mobile app

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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First Pavlov Saint Petersburg University

Saint Petersburg, , Russia

Site Status RECRUITING

Saint Petersburg State University Hospital

Saint Petersburg, , Russia

Site Status RECRUITING

Countries

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Russia

Facility Contacts

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Dmitriy Gorelov, MD

Role: primary

+79217964892

Nariman Gadzhiev, MD

Role: primary

+79214311436

Other Identifiers

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Stone_MD_forgotten_stent

Identifier Type: -

Identifier Source: org_study_id

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