Neurogenic Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis

Sponsor
Koç University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05587101
Collaborator
(none)
30
1
31.4
1

Study Details

Study Description

Brief Summary

There is no consensus in the literature upon the neurourological diagnostic algorithm of the patients with multiple sclerosis (MS). The primary aim of the study is phenotyping the patients with MS. These phenotypes might guide Neurology and Urology specialists during diagnosis and treatment. Secondary aim of this study is to define the presence and severity of urological symptoms' and disorders', involving the patients with diagnosis of MS less than 5 years into a urological follow-up and treatment process. Our study might include 4 visits (the first visit, 3rd month, 6th month and 12th month visit). Questionnaires, uroflowmetry and bladder diary might be repeated on each visit. Filling cystometry and pressure-flow study will be performed only on the first visit. All patients will receive 6 different questionnaires which aim to define the severity and presence of lower urinary tract symptoms. Bladder diary is an online application which will represent at least 3 days of frequency, urgency, incontinence episodes and the amount of fluid intake, and urination. The phenotypes would be defined after performing the first visit diagnostic tools (all of the tools are necessary during the diagnostic algorithm of neurogenic lower urinary tract symptoms). The phenotypes will be defined as: a. no symptoms with normal urodynamics, b. Lower urinary tract symptoms with normal urodynamics, c. no symptoms with abnormal urodynamics, d.lower urinary tract symptoms with abnormal urodynamics. During a follow-up period of 1 year, changes in the bladder diaries and scores in questionnaires of these groups will be compared on each visit.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Urodynamic Study (Filling cystometry and pressure-flow study)
  • Diagnostic Test: Questionnaires
  • Diagnostic Test: Uroflowmetry

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Optimal Diagnostic Algorithm for Neurogenic Lower Urinary Tract Symptoms in Patients With MS
Actual Study Start Date :
Oct 19, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Changes in Questionnaire Scores [every 3 months]

    Bladder dysfunction

  2. Changes in Urodynamics [every 3 months]

    Bladder dysfunction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

The patients who are followed up by Department of Neurology with MS diagnosis less than 5 years

Exclusion Criteria:
  1. Patients who are not eligible for completing questionnaires, bladder diaries.

  2. Patients who have anatomical disorders preventing lithotomy position during urodynamic study.

  3. Patients in relapsing period of MS

  4. Patients who have symptoms of urinary tract infection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Koç University Istanbul Turkey 34010

Sponsors and Collaborators

  • Koç University

Investigators

  • Principal Investigator: Ersin Köseoğlu, Koç University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Koç University
ClinicalTrials.gov Identifier:
NCT05587101
Other Study ID Numbers:
  • KocUrol
First Posted:
Oct 19, 2022
Last Update Posted:
Oct 19, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2022