Reproductibility of Cystometry in Multiple Sclerosis Patient

NCT ID: NCT03451175

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-02
• Study Completion Date: 2018-01-01

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.

Conditions

Lower Urinary Tract Symptoms; Cystometry; Multiple Sclerosis; Overactive Bladder; Overactive Detrusor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre and Marie Curie University

OTHER

Sponsor Role: lead

Responsible Party

Gérard Amarenco

Head of Neuro-Urology Department, Tenon Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerard AMARENCO, PhD

Role: PRINCIPAL_INVESTIGATOR

GREEN GRC-01, Neuro-urology, hôpital Tenon

Locations

Service de Neuro-urology, hôpital Tenon

Paris, , France

Countries

France

Other Identifiers

P. GREEN 0001

Identifier Type: -

Identifier Source: org_study_id