Reproductibility of Cystometry in Multiple Sclerosis Patient

Completed

• Conditions: Multiple Sclerosis; Overactive Bladder; Overactive Detrusor; Lower Urinary Tract Symptoms; Cystometry

• Registration Number: NCT03451175
• Lead Sponsor: Pierre and Marie Curie University

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.

Study Timeline

• Study Start: 2017-07-02
• Primary Completion: 2017-11-01
• Study Completion: 2018-01-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-23
• Last Update Submitted: 2018-02-23
• Study First Posted: 2018-03-01
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reproductibility of urodynamic : Pressure maximum	1 Day : during the urodynamic assessment	Reproductibility of Pressure Maximum (in cmH2O) in the three cystometries evaluated using an intra class correlation
Reproductibility of urodynamic : Pressure of the first involuntary detrusor contraction (IDC)	1 Day : during the urodynamic assessment	Reproductibility of pressure of the first involuntary detrusor contraction (in cmH2O) in the three cystometries evaluated using an intra class correlation
Reproductibility of urodynamic Capacity Cystometric Maximum (CCM)	1 Day : during the urodynamic assessment	Reproductibility of Capacity cystometric maximum (in ml) in the three cystometries evaluated using an intra class correlation
Reproductibility of urodynamic : volume of filling for the first IDC	1 Day : during the urodynamic assessment	Reproductibility of volume of filling for the first involuntary detrusor contraction (in cmH2O) in the three cystometries evaluated using an intra class correlation

Secondary Outcome Measures

Name	Time	Method
Comparaison of urodynamic parameters between naive treatment patient and non naive treatment patients	1 Day : during the urodynamic assessment	Comparaison urodynamic parameters (CCM, Maximum pressure, volume filling of the first IDC, pressure of the first IDC) using a T student test

Trial Locations

Locations (1)

Service de Neuro-urology, hôpital Tenon; 🇫🇷 Paris, France