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Completed

NCT Number: NCT03451175

Reproductibility of Cystometry in Multiple Sclerosis Patient

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

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Key information

Conditions

Lower Urinary Tract Symptoms Autoimmune Diseases Autoimmune Diseases of the Nervous System Cystometry Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Male Urogenital Diseases Multiple Sclerosis Nervous System Diseases Overactive Bladder Overactive Detrusor Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Neuro-urology, hôpital Tenon

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Reproductibility of urodynamic Capacity Cystometric Maximum (CCM)

    Time frame: 1 Day : during the urodynamic assessment

    Reproductibility of Capacity cystometric maximum (in ml) in the three cystometries evaluated using an intra class correlation

  2. Reproductibility of urodynamic : Pressure maximum

    Time frame: 1 Day : during the urodynamic assessment

    Reproductibility of Pressure Maximum (in cmH2O) in the three cystometries evaluated using an intra class correlation

  3. Reproductibility of urodynamic : Pressure of the first involuntary detrusor contraction (IDC)

    Time frame: 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

  4. Reproductibility of urodynamic : volume of filling for the first IDC

    Time frame: 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 outcomes

  1. Comparaison of urodynamic parameters between naive treatment patient and non naive treatment patients

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pierre and Marie Curie University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 1, 2018
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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