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

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ClinicalTrials.gov Identifier: NCT06022952
Recruitment Status : Recruiting
First Posted : September 5, 2023
Last Update Posted : September 5, 2023
Sponsor:
Information provided by (Responsible Party):
St. Petersburg State Pavlov Medical University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2023
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 1, 2023
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Removed on time [ Time Frame: 30 days ]
    Number of patients who removed the stent on time in both groups

  2. Delayed stent removal [ Time Frame: 30 days ]
    Number of patients who delayed stent removal in both groups (less than 14 days)

  3. Forgotten stent removal [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022952


Locations
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Russian Federation
First Pavlov Saint Petersburg University Recruiting
Saint Petersburg, Russian Federation, 197342
Contact: Dmitriy Gorelov, MD    +79217964892    dsgorelov@mail.ru   
Saint Petersburg State University Hospital Recruiting
Saint Petersburg, Russian Federation
Contact: Nariman Gadzhiev, MD    +79214311436    nariman.gadjiev@gmail.com   
Sponsors and Collaborators
St. Petersburg State Pavlov Medical University
More Information
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Responsible Party: St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier: NCT06022952    
Other Study ID Numbers: Stone_MD_forgotten_stent
First Posted: September 5, 2023    Key Record Dates
Last Update Posted: September 5, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urolithiasis
Urinary Calculi
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Calculi
Pathological Conditions, Anatomical