Clinical trial NCT03650179: Influence of the Urine Stream Interruption Exercise on the Micturition
Official title: Influence of the Urine Stream Interruption Exercise on the Micturition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voiding Function
Keywords: urine stream interruption exercise
voiding function
pelvic floor muscles exercise
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting for an urodynamic assessment in a neuro-urology and functional explorations department

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* urological or neurological disease

Primary outcomes:
measure: post-void residual volume
timeFrame: 1 Day : during the urodynamic assessment
Secondary outcomes:
measure: maximal flow rate
timeFrame: 1 Day : during the urodynamic assessment
measure: time to reach the maximal flow rate
timeFrame: 1 Day : during the urodynamic assessment
measure: voiding time
timeFrame: 1 Day : during the urodynamic assessment
measure: the slope of the uroflowmetry (corresponding to the flow velocity acceleration)
timeFrame: 1 Day : during the urodynamic assessment
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Neuro-urology, Tenon hospital
Study officials:
affiliation: GREEN GRC-01, Neuro-urology department, Hôpital Tenon
name: Gérard Amarenco, PhD
role: PRINCIPAL_INVESTIGATOR
References: