- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03650179
Influence of the Urine Stream Interruption Exercise on the Micturition
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75020
- Department of Neuro-urology, Tenon hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- follow in neuro-urology for functional digestive disease
- Appointment for urodynamic assessment
Exclusion Criteria:
- urological or neurological disease
Study Plan
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.
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Observational study : No intervention.
Only exporting data
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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
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comparison between post-void residual volume during normal micturition and exercise of urine stream interruption
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1 Day : during the urodynamic assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximal flow rate
Time Frame: 1 Day : during the urodynamic assessment
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comparison between maximal flow rate during normal micturition and exercise of urine stream interruption
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1 Day : during the urodynamic assessment
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time to reach the maximal flow rate
Time Frame: 1 Day : during the urodynamic assessment
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comparison between time to reach maximal flow rate during normal micturition and exercise of urine stream interruption
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1 Day : during the urodynamic assessment
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voiding time
Time Frame: 1 Day : during the urodynamic assessment
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comparison between the voiding time during normal micturition and exercise of urine stream interruption
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1 Day : during the urodynamic assessment
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the slope of the uroflowmetry (corresponding to the flow velocity acceleration)
Time Frame: 1 Day : during the urodynamic assessment
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comparison between the slope of the uroflowmetry during normal micturition and exercise of urine stream interruption
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1 Day : during the urodynamic assessment
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Collaborators and Investigators
Investigators
- Principal Investigator: Gérard Amarenco, PhD, GREEN GRC-01, Neuro-urology department, Hôpital Tenon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P GREEN GRC 01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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