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Remote Monitoring of Uroflowmetry

Primary Purpose

Lower Urinary Tract Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Uroflowmetry
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lower Urinary Tract Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute for Urology and Reproductive Health, Sechenov University.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with LUTS

Arm Description

Patients who are indicated for uroflowmetry

Outcomes

Primary Outcome Measures

Uroflowmetry during 24 hours
Registration of remote uroflowmetry using portable uroflowmeter during 24 hours

Secondary Outcome Measures

Full Information

First Posted
August 6, 2020
Last Updated
July 21, 2021
Sponsor
I.M. Sechenov First Moscow State Medical University
Collaborators
Institute for Digital Medicine (WisDM)
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1. Study Identification

Unique Protocol Identification Number
NCT04506697
Brief Title
Remote Monitoring of Uroflowmetry
Official Title
Study of Remote Monitoring of Urination Dynamics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University
Collaborators
Institute for Digital Medicine (WisDM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with LUTS
Arm Type
Experimental
Arm Description
Patients who are indicated for uroflowmetry
Intervention Type
Procedure
Intervention Name(s)
Uroflowmetry
Intervention Description
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.
Primary Outcome Measure Information:
Title
Uroflowmetry during 24 hours
Description
Registration of remote uroflowmetry using portable uroflowmeter during 24 hours
Time Frame
1 day

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Enikeev, M.D., Ph.D.
Phone
+79670897154
Email
dvenikeev@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Taratkin
Phone
+79670897154
Email
marktaratkin@gmail.com
Facility Information:
Facility Name
Institute for Urology and Reproductive Health, Sechenov University.
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Enikeev, M.D., Ph.D
Phone
+7 9670897154
Email
enikeev-dv@1msmu.ru
First Name & Middle Initial & Last Name & Degree
Mark Taratkin, MD
Phone
+7 9670897154
Email
marktaratkin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Monitoring of Uroflowmetry

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