Remote Monitoring of Uroflowmetry
Sponsor
I.M. Sechenov First Moscow State Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04506697
Collaborator
Institute for Digital Medicine (WisDM) (Other)
30
1
1
21.7
1.4
Study Details
Study Description
Brief Summary
The aim of the study is to assess the possibility of using remote monitoring of urination.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of Remote Monitoring of Urination Dynamics
Actual Study Start Date
:
Mar 12, 2020
Anticipated Primary Completion Date
:
Dec 31, 2021
Anticipated Study Completion Date
:
Dec 31, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients with LUTS Patients who are indicated for uroflowmetry |
Procedure: Uroflowmetry
The patient is given a portable uroflowmeter for performing uroflowmetry at home, and the NetHealth app is installed on his smartphone. The patient registers his account in the app. A personal uroflowmeter is paired with the patient's smartphone using the installed app via a Bluetooth connection. The investigator trains the patient how to use the app and how to conduct uroflowmetry at home. The patient within 1 day (24 hours) at home performs uroflowmetry during all urination, including night urination.
|
Outcome Measures
Primary Outcome Measures
- Uroflowmetry during 24 hours [1 day]
Registration of remote uroflowmetry using portable uroflowmeter during 24 hours
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Men over 18 years old.
-
The patient has performed uroflowmetry according to indications in the hospital no later than 7 days before the planned inclusion in the trial.
-
Qmax = or <15 ml / sec.
-
The patient has a smartphone (with Android 4.0 and higher, iOS 10.0 and higher) with Internet access
Exclusion Criteria:
-
A patient with emergency conditions requiring surgical treatment
-
Intellectual and cognitive abilities of the patient that do not allow him to follow the doctor's instructions and make it difficult to use the smartphone.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute for Urology and Reproductive Health, Sechenov University. | Moscow | Russian Federation | 119991 |
Sponsors and Collaborators
- I.M. Sechenov First Moscow State Medical University
- Institute for Digital Medicine (WisDM)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Dmitry Enikeev, MD, PhD,
Deputy Director for Research,
I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier:
NCT04506697
Other Study ID Numbers:
- CM-001
First Posted:
Aug 10, 2020
Last Update Posted:
Jul 22, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: