NCT04506697

Brief Summary

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

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

March 12, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1.8 years

First QC Date

August 6, 2020

Last Update Submit

July 21, 2021

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

  • Uroflowmetry during 24 hours

    Registration of remote uroflowmetry using portable uroflowmeter during 24 hours

    1 day

Study Arms (1)

Patients with LUTS

EXPERIMENTAL

Patients who are indicated for uroflowmetry

Procedure: Uroflowmetry

Interventions

UroflowmetryPROCEDURE

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.

Patients with LUTS

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men over 18 years old.
  • Qmax = or \<15 ml / sec.
  • The patient has a smartphone (with Android 4.0 and higher, iOS 10.0 and higher) with Internet access

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

+79670897154dvenikeev@gmail.com

Mark Taratkin

CONTACT

+79670897154marktaratkin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director for Research

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

March 12, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)