Remote Monitoring of Uroflowmetry

NCT ID: NCT04506697

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with LUTS

Patients who are indicated for uroflowmetry

Group Type EXPERIMENTAL

Uroflowmetry

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Institute for Digital Medicine (WisDM)

OTHER

Sponsor Role collaborator

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Dmitry Enikeev, MD, PhD

Deputy Director for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Urology and Reproductive Health, Sechenov University.

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Dmitry Enikeev, M.D., Ph.D.

Role: CONTACT

+79670897154

Mark Taratkin

Role: CONTACT

+79670897154

Facility Contacts

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Dmitry Enikeev, M.D., Ph.D

Role: primary

+7 9670897154

Mark Taratkin, MD

Role: backup

+7 9670897154

Other Identifiers

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CM-001

Identifier Type: -

Identifier Source: org_study_id

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