UrolithiasisNCT06022952
The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents
A study testing Stone MD stent radar in people with Urolithiasis, run by St. Petersburg State Pavlov Medical University at 2 sites in Russia.
Trial summary
The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Stone MD stent radar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Feb 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male and female patients aged 18 to 80 years who have a Ch 4.7-6.0 polyurethane ureteral stent
Who cannot join
- Active phase of urinary tract infection
- Insufficient level of social adaptation
- The patient does not have a smartphone with Internet access
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
First Pavlov Saint Petersburg University
Saint Petersburg, 197342
Dmitriy Gorelov, MD, +79217964892, dsgorelov@mail.ru
- Recruiting
Saint Petersburg State University Hospital
Saint Petersburg
Nariman Gadzhiev, MD, +79214311436, nariman.gadjiev@gmail.com
About this study
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
The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents
Read the detailed description
Inclusion Criteria:
- 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:
- Assessment of Stone-free status after surgery by performing computed tomography of kidneys and urinary tract without intravenous contrasting 1 month after surgery
- Conditions
- Urolithiasis
- Being tested
- Stone MD stent radar
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stone MD stent radarOther
Mobile app
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients who have used the Stone MD mobile app Receives: Other: Stone MD stent radar |
| Group B | Active comparator | Patients who have not used the Stone MD mobile app Receives: Other: Stone MD stent radar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removed on time
Number of patients who removed the stent on time in both groups
Measured: 30 days
Delayed stent removal
Number of patients who delayed stent removal in both groups (less than 14 days)
Measured: 30 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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Feb 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022952
- Sponsor's protocol ID
- Stone_MD_forgotten_stent
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06022952
- Acronym / sponsor ID
- Stone_MD_forgotten_stent
- Conditions
- Urolithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents
Detailed description
Inclusion Criteria:
- 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:
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Stone MD stent radarPatients who have used the Stone MD mobile app |
| Group B | Active comparator | Other: Stone MD stent radarPatients who have not used the Stone MD mobile app |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Male and female patients aged 18 to 80 years who have a Ch 4.7-6.0 polyurethane ureteral stent
Key exclusion criteria (3 listed)
- Active phase of urinary tract infection
- Insufficient level of social adaptation
- The patient does not have a smartphone with Internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stone MD stent radarMobile app | Other | Group A, Group B |
Primary outcome
Removed on time
Time frame: 30 days
Number of patients who removed the stent on time in both groups
Delayed stent removal
Time frame: 30 days
Number of patients who delayed stent removal in both groups (less than 14 days)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Urolithiasis
Enrolling by invitationObservational study
Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
Urolithiasis, Intrarenal Pressure
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saint Petersburg State University Hospital
Saint Petersburg, Russia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stone MD stent radar in people with Urolithiasis, run by St. Petersburg State Pavlov Medical University at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Removed on time (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.