Remote Monitoring of Uroflowmetry

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Study of Remote Monitoring of Urination Dynamics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506697
• Other study ID #: CM-001
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Dmitry Enikeev, M.D., Ph.D.
• Phone: +79670897154
• Email: dvenikeev[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess the possibility of using remote monitoring of urination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men over 18 years old.

2. The patient has performed uroflowmetry according to indications in the hospital no later than 7 days before the planned inclusion in the trial.

3. Qmax = or <15 ml / sec.

4. The patient has a smartphone (with Android 4.0 and higher, iOS 10.0 and higher) with Internet access

Exclusion Criteria:

1. A patient with emergency conditions requiring surgical treatment

2. 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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Institute for Urology and Reproductive Health, Sechenov University.	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University	Institute for Digital Medicine (WisDM)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uroflowmetry during 24 hours	Registration of remote uroflowmetry using portable uroflowmeter during 24 hours	1 day