Onset of Lower Urinary Tract Symptoms in Multiple Sclerosis Patients

NCT06226831 | Unknown

• 1 other identifier: MS001
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective, non-interventional case-control study, the patients were asked about their first lower-urinary tract symptoms and the date of their onset, using a structured interview. The information was matched with the medical records.

Conditions

Lower Urinary Tract Symptoms; Multiple Sclerosis

Keywords

Multiple Sclerosis; Lower-Urinary Tract Symptoms; Urinary Urgency; Cerebellar and/or Pyramidal Symptoms

Outcome Measures

Primary Outcomes (1)

• LUTS onset

  The time of LUTS onset in relation to the diagnosis of MS diagnosis (before or after) will be observed in months, during the structured interviews with the study subjects.

  1 hour of structured interview

Secondary Outcomes (2)

• Course of disease (clinical examination)

  5 years

• Course of disease (EDSS scale)

  5 years

Study Arms (2)

MS with LUTS

Patients with multiple sclerosis with LUTS symptoms.

Other: Structured interview

MS without LUTS

Patients with multiple sclerosis without LUTS symptoms.

Other: Structured interview

Interventions

Structured interview OTHER

In-person structured interviews will be performed by the investigators.

MS with LUTS; MS without LUTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with the diagnosis of MS, with or without LUTS.

You may qualify if:

• diagnosis of multiple sclerosis
• adult patients
• signed informed consent

You may not qualify if:

• \- none

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (13)

• Dilokthornsakul P, Valuck RJ, Nair KV, Corboy JR, Allen RR, Campbell JD. Multiple sclerosis prevalence in the United States commercially insured population. Neurology. 2016 Mar 15;86(11):1014-21. doi: 10.1212/WNL.0000000000002469. Epub 2016 Feb 17.

  PMID: 26888980 BACKGROUND

• Rosati G. The prevalence of multiple sclerosis in the world: an update. Neurol Sci. 2001 Apr;22(2):117-39. doi: 10.1007/s100720170011.

  PMID: 11603614 BACKGROUND

• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.

  PMID: 12559262 BACKGROUND

• Nortvedt MW, Riise T, Myhr KM, Landtblom AM, Bakke A, Nyland HI. Reduced quality of life among multiple sclerosis patients with sexual disturbance and bladder dysfunction. Mult Scler. 2001 Aug;7(4):231-5. doi: 10.1177/135245850100700404.

  PMID: 11548982 BACKGROUND

• Khalaf KM, Coyne KS, Globe DR, Malone DC, Armstrong EP, Patel V, Burks J. The impact of lower urinary tract symptoms on health-related quality of life among patients with multiple sclerosis. Neurourol Urodyn. 2016 Jan;35(1):48-54. doi: 10.1002/nau.22670. Epub 2014 Oct 18.

  PMID: 25327401 BACKGROUND

• Khalaf KM, Coyne KS, Globe DR, Armstrong EP, Malone DC, Burks J. Lower urinary tract symptom prevalence and management among patients with multiple sclerosis. Int J MS Care. 2015 Jan-Feb;17(1):14-25. doi: 10.7224/1537-2073.2013-040.

  PMID: 25741223 BACKGROUND

• Al Dandan HB, Coote S, McClurg D. Prevalence of Lower Urinary Tract Symptoms in People with Multiple Sclerosis: A Systematic Review and Meta-analysis. Int J MS Care. 2020 Mar-Apr;22(2):91-99. doi: 10.7224/1537-2073.2019-030.

  PMID: 32410904 BACKGROUND

• Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.

  PMID: 24871874 BACKGROUND

• KURTZKE JF. A new scale for evaluating disability in multiple sclerosis. Neurology. 1955 Aug;5(8):580-3. doi: 10.1212/wnl.5.8.580. No abstract available.

  PMID: 13244774 BACKGROUND

• Medina-Polo J, Adot JM, Allue M, Arlandis S, Blasco P, Casanova B, Matias-Guiu J, Madurga B, Meza-Murillo ER, Muller-Arteaga C, Rodriguez-Acevedo B, Vara J, Zubiaur MC, Lopez-Fando L. Consensus document on the multidisciplinary management of neurogenic lower urinary tract dysfunction in patients with multiple sclerosis. Neurourol Urodyn. 2020 Feb;39(2):762-770. doi: 10.1002/nau.24276. Epub 2020 Jan 15.

  PMID: 31943361 BACKGROUND

• Krhut J, Hradilek P, Zapletalova O. Analysis of the upper urinary tract function in multiple sclerosis patients. Acta Neurol Scand. 2008 Aug;118(2):115-9. doi: 10.1111/j.1600-0404.2008.00992.x. Epub 2008 Feb 25.

  PMID: 18307573 BACKGROUND

• Phe V, Pakzad M, Curtis C, Porter B, Haslam C, Chataway J, Panicker JN. Urinary tract infections in multiple sclerosis. Mult Scler. 2016 Jun;22(7):855-61. doi: 10.1177/1352458516633903. Epub 2016 Feb 18.

  PMID: 26892318 BACKGROUND

• Correale J, Fiol M, Gilmore W. The risk of relapses in multiple sclerosis during systemic infections. Neurology. 2006 Aug 22;67(4):652-9. doi: 10.1212/01.wnl.0000233834.09743.3b. Epub 2006 Jul 26.

  PMID: 16870812 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Multiple Sclerosis

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

Study Officials

• Jan Krhut, prof.,MD, PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: June 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)