NCT01617512

Brief Summary

The purpose of this study is to determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 15, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

1.4 years

First QC Date

December 15, 2011

Last Update Submit

April 10, 2014

Conditions

Urinary Disorders

Outcome Measures

Primary Outcomes (1)

  • Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data.

    Intrinsic characteristics (sensitivity, specificity, ROC curve) of the test for detecting in automated way the activities among all the daily accelerometer data

    6 months

Secondary Outcomes (1)

  • Score of satisfaction with the use of the medical device, assessed by the patients

    6 months

Interventions

LIS302DL accelerometerDEVICE

Recording for 24 hours accelerations related to daily physical activity of the patient.

Eligibility Criteria

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

You may qualify if:

  • man
  • patients fitted with artificial urinary sphincter
  • patients affiliated to social security or similar regime

You may not qualify if:

  • patient do not speak french
  • patient unable to express his consent
  • patient hospitalize without consent
  • patient under legal protection
  • patient deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Grenoble, France

Location

Study Officials

  • Alexandre Moreau-gaudry, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 15, 2011

First Posted

June 12, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations

FR(1)