Influence of the Urine Stream Interruption Exercise on the Micturition

September 24, 2019 updated by: Gérard Amarenco, Pierre and Marie Curie University
This study assess micturition characteristic during and after a urine stream interruption exercise in patient without neurological or urologic disease.

Study Overview

Status

Completed

Conditions

Detailed Description

Urine stream interruption during voluntary voiding is often performed by women as a pelvic floor muscle exercise to develop urinary strength and avoid urinary incontinence. To our knowledge, there is no recommendation for performing urine stream interruption. Without evidence based data, stooping the urinary flow is reported as a risk of post void residual and urinary infection. The experts did not recommended to practice urine stream interruption as a pelvic floor exercise in urinary incontinence. However, during pelvic floor muscle training for urinary incontinence, exercises of urine stream interruption are often performed without knowledge of their consequences. The aim of this study is to assess micturition characteristic during and after a urine stream interruption exercise.

In this study, the investigators will compare the two uroflowmetries usually done in a Neuro-urology department of a University Hospital. Patient without neurological or urologic disease, consulting for a global evaluation of functional digestive disease and performing an urodynamic study will be included. During the urodynamic evaluation, two uroflowmetries are performed : one conventional uroflowmetry complying with the International Continence Society (ICS) recommendations and one uroflowmetry during exercise of urine stream interruption, as usually done in the department. Each uroflowmetry will be performed when the patient will feel a ''normal'' desire to void. For the urine stream interruption micturition, patients will be asked to "begin the micturition, stop at 3 seconds of micturition, when the stream is interrupt, start again voiding, again stop at 3 seconds of micturition and repeat this maneuver until the end of the micturition". As usual, sonographic estimation of post-void residual volume will complete each uroflowmetry.

The investigators will compare the voiding volume, the post-void residual volume, the maximal flow rate, the time to reach the maximal flow rate, the voiding time and the slope of the uroflowmetry (corresponding to the flow velocity acceleration) between the two uroflowmetries. For each voiding sequence of the urine stream interruption micturition the following parameters will be reported and compared: voiding volume and duration, maximal flow rate, time to reach the maximal flow rate, the latency to restart the micturition between each voiding sequence and the slope of the uroflowmetry.

Statistical analysis will be carried out using R 3.2.3 software (R Development Core Team, http://www.R-project.org) and R studio version 1.0.136. Differences between the two uroflowmetries will be evaluated using Student test. Correlation between the place of the voiding sequence in the urine stream interruption micturition and the different parameters will be evaluated using Pearson's correlations.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75020
        • Department of Neuro-urology, Tenon hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • urological or neurological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Observational study : No intervention. Only exporting data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-void residual volume
Time Frame: 1 Day : during the urodynamic assessment
comparison between post-void residual volume during normal micturition and exercise of urine stream interruption
1 Day : during the urodynamic assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal flow rate
Time Frame: 1 Day : during the urodynamic assessment
comparison between maximal flow rate during normal micturition and exercise of urine stream interruption
1 Day : during the urodynamic assessment
time to reach the maximal flow rate
Time Frame: 1 Day : during the urodynamic assessment
comparison between time to reach maximal flow rate during normal micturition and exercise of urine stream interruption
1 Day : during the urodynamic assessment
voiding time
Time Frame: 1 Day : during the urodynamic assessment
comparison between the voiding time during normal micturition and exercise of urine stream interruption
1 Day : during the urodynamic assessment
the slope of the uroflowmetry (corresponding to the flow velocity acceleration)
Time Frame: 1 Day : during the urodynamic assessment
comparison between the slope of the uroflowmetry during normal micturition and exercise of urine stream interruption
1 Day : during the urodynamic assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gérard Amarenco, PhD, GREEN GRC-01, Neuro-urology department, Hôpital Tenon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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