NCT03650179

Brief Summary

This study assess micturition characteristic during and after a urine stream interruption exercise in patient without neurological or urologic disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

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

Study Start

First participant enrolled

August 23, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1 month

First QC Date

August 27, 2018

Last Update Submit

September 24, 2019

Conditions

Voiding Function

Keywords

urine stream interruption exercisevoiding functionpelvic floor muscles exercise

Outcome Measures

Primary Outcomes (1)

  • post-void residual volume

    comparison between post-void residual volume during normal micturition and exercise of urine stream interruption

    1 Day : during the urodynamic assessment

Secondary Outcomes (4)

  • maximal flow rate

    1 Day : during the urodynamic assessment

  • time to reach the maximal flow rate

    1 Day : during the urodynamic assessment

  • voiding time

    1 Day : during the urodynamic assessment

  • the slope of the uroflowmetry (corresponding to the flow velocity acceleration)

    1 Day : during the urodynamic assessment

Study Arms (1)

Patients enrolled in the cohort

Patients over 18 years old, consulting for functional digestive disease, without neurologic or urologic disease, and performing an urodynamic examination in neuro-urology and functional explorations department.

Other: Observational study : No intervention

Interventions

Observational study : No interventionOTHER

Observational study : No intervention. Only exporting data

Patients enrolled in the cohort

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting for an urodynamic assessment in a neuro-urology and functional explorations department

You may qualify if:

  • follow in neuro-urology for functional digestive disease
  • Appointment for urodynamic assessment

You may not qualify if:

  • urological or neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuro-urology, Tenon hospital

Paris, 75020, France

Location

Study Officials

  • Gérard Amarenco, PhD

    GREEN GRC-01, Neuro-urology department, Hôpital Tenon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neuro-urology department, Tenon hospital

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 28, 2018

Study Start

August 23, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)