Clinical trial NCT03451175: Reproductibility of Cystometry in Multiple Sclerosis Patient
Official title: Reproductibility of Cystometry in Multiple Sclerosis Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Cystometry
Multiple Sclerosis
Overactive Bladder
Overactive Detrusor
Keywords: Overactive Detrusor
Multiple Sclerosis
Reproductibility
Cystometry
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple sclerosis patients with overactive detrusor consulting in neurobiology center.

Brief summary: This study evaluates the reproductibility (quantitative and qualitative) of cystometry in mutiple sclerosis patients.

Detailed description: Some studies have evaluated the reproductibility of urodynamics in women with stress incontinence, and demonstrated a poor reproductibility of urodynamic parameters for a part of the studies and a good reproductibility for the others. There is only three studies investigating the reproductibility of repeated cystometries in patients with overactive detrusor and neurogenic lower tract dysfunction. The most common etiology in these studies is spinal cord injury. Only one article includes MS patients with lower urinary tract symptoms (22 patients among 226 with other etiologies).

The aim of this study was to assess the short term reproductibility in multiple sclerosis patients with qualitative and quantitative urodynamic data.

The authors conducted a prospective analysis in our Neuro-urology department of a University Hospital . All patient with Multiple Sclerosis referred for urinary disorders, coming for a urodynamic evaluation with multiple cystometries during the study were included if they had a detrusor overactivity for a filling of 300 ml or less on the first cystometry. The main exclusion criteria were a significate difference between the filling volume during the study and the volume truly of water truly collected after catheterization, an urinary tract infection, or an other acute disease.The investigators performed a first cystometry and looked for a detrusor overactivity, if the investigators discovered an involuntary detrusor contraction for a filling of 300 ml or less, the authors realized two others cystometries (filling rate of 50 mL/min) after informed consent. The volume and pressure at which the first and the maximal involuntary detrusor contraction, MCC were documented.

Eligibility criteria: Inclusion Criteria:

* All patient with Multiple Sclerosis referred for urinary disorders,
* coming for a urodynamic evaluation with multiple cystometries during the study - detrusor overactivity for a filling of 300 ml or less on the first cystometry.

Exclusion Criteria:

* significate difference between the filling volume during the study and the volume truly of water truly collected after catheterization,
* an urinary tract infection,
* an other acute disease.

Primary outcomes:
measure: Reproductibility of urodynamic Capacity Cystometric Maximum (CCM)
timeFrame: 1 Day : during the urodynamic assessment
measure: Reproductibility of urodynamic : Pressure maximum
timeFrame: 1 Day : during the urodynamic assessment
measure: Reproductibility of urodynamic : Pressure of the first involuntary detrusor contraction (IDC)
timeFrame: 1 Day : during the urodynamic assessment
measure: Reproductibility of urodynamic : volume of filling for the first IDC
timeFrame: 1 Day : during the urodynamic assessment
Secondary outcomes:
measure: Comparaison of urodynamic parameters between naive treatment patient and non naive treatment patients
timeFrame: 1 Day : during the urodynamic assessment
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Neuro-urology, hôpital Tenon
Study officials:
affiliation: GREEN GRC-01, Neuro-urology, hôpital Tenon
name: Gerard AMARENCO, PhD
role: PRINCIPAL_INVESTIGATOR
References: