NCT06022952

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

August 28, 2023

Last Update Submit

August 28, 2023

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (3)

  • Removed on time

    Number of patients who removed the stent on time in both groups

    30 days

  • Delayed stent removal

    Number of patients who delayed stent removal in both groups (less than 14 days)

    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)

    30 days

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients who have used the Stone MD mobile app

Other: Stone MD stent radar

Group B

ACTIVE COMPARATOR

Patients who have not used the Stone MD mobile app

Other: Stone MD stent radar

Interventions

Stone MD stent radarOTHER

Mobile app

Group AGroup B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Male and female patients aged 18 to 80 years who have a Ch 4.7-6.0 polyurethane ureteral stent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

First Pavlov Saint Petersburg University

Saint Petersburg, 197342, Russia

RECRUITING

Saint Petersburg State University Hospital

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 5, 2023

Study Start

February 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

RU(2)