Reproductibility of Cystometry in Multiple Sclerosis Patient

Multiple Sclerosis Clinical Trial

Official title:

Reproductibility of Cystometry in Multiple Sclerosis Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451175
• Other study ID #: P. GREEN 0001
• Status: Completed
• Phase: N/A
• First received: February 11, 2018
• Last updated: February 23, 2018
• Start date: July 2, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: February 2018
• Source: Pierre and Marie Curie University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 1, 2018
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystometry
• Lower Urinary Tract Symptoms
• Multiple Sclerosis
• Overactive Bladder
• Overactive Detrusor
• Sclerosis
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
France	Service de Neuro-urology, hôpital Tenon	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	Reproductibility of urodynamic Capacity Cystometric Maximum (CCM)	Reproductibility of Capacity cystometric maximum (in ml) in the three cystometries evaluated using an intra class correlation	1 Day : during the urodynamic assessment
Primary	Reproductibility of urodynamic : Pressure maximum	Reproductibility of Pressure Maximum (in cmH2O) in the three cystometries evaluated using an intra class correlation	1 Day : during the urodynamic assessment
Primary	Reproductibility of urodynamic : Pressure of the first involuntary detrusor contraction (IDC)	Reproductibility of pressure of the first involuntary detrusor contraction (in cmH2O) in the three cystometries evaluated using an intra class correlation	1 Day : during the urodynamic assessment
Primary	Reproductibility of urodynamic : volume of filling for the first IDC	Reproductibility of volume of filling for the first involuntary detrusor contraction (in cmH2O) in the three cystometries evaluated using an intra class correlation	1 Day : during the urodynamic assessment
Secondary	Comparaison of urodynamic parameters between naive treatment patient and non naive treatment patients	Comparaison urodynamic parameters (CCM, Maximum pressure, volume filling of the first IDC, pressure of the first IDC) using a T student test	1 Day : during the urodynamic assessment