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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03650179
Other study ID # P GREEN GRC 01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 23, 2018
Est. completion date September 30, 2018

Study information

Verified date September 2019
Source Pierre and Marie Curie University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- follow in neuro-urology for functional digestive disease

- Appointment for urodynamic assessment

Exclusion Criteria:

- urological or neurological disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational study : No intervention
Observational study : No intervention. Only exporting data

Locations

Country Name City State
France Department of Neuro-urology, Tenon hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Pierre and Marie Curie University

Country where clinical trial is conducted

France, 

Outcome

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