Remote Monitoring of Uroflowmetry

Study of Remote Monitoring of Urination Dynamics

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

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: Procedure: Uroflowmetry

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Taratkin; Phone Number: +79670897154; Email: marktaratkin@gmail.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Institute for Urology and Reproductive Health, Sechenov University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uroflowmetry during 24 hours	Registration of remote uroflowmetry using portable uroflowmeter during 24 hours	1 day

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Collaborators: Institute for Digital Medicine (WisDM)

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 12, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (ACTUAL): August 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: CM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No