Reproductibility of Cystometry in Multiple Sclerosis Patient

NCT03451175 | Completed

• 1 other identifier: P. GREEN 0001
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Overactive Detrusor; Multiple Sclerosis; Reproductibility; Cystometry

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Comparaison of urodynamic parameters between naive treatment patient and non naive treatment patients

  1 Day : during the urodynamic assessment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple sclerosis patients with overactive detrusor consulting in neurobiology center.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pierre and Marie Curie University: lead

Study Sites (1)

Service de Neuro-urology, hôpital Tenon

Paris, France

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Multiple Sclerosis; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Gerard AMARENCO, PhD

  GREEN GRC-01, Neuro-urology, hôpital Tenon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neuro-Urology Department, Tenon Hospital

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: March 1, 2018
• Study Start: July 2, 2017
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

FR (1)