Neurogenic Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis

NCT05587101 | Unknown

• 1 other identifier: KocUrol
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Neurogenic Bladder

Outcome Measures

Primary Outcomes (2)

• Changes in Questionnaire Scores

  Bladder dysfunction

  every 3 months

• Changes in Urodynamics

  Bladder dysfunction

  every 3 months

Interventions

Urodynamic Study (Filling cystometry and pressure-flow study) DIAGNOSTIC_TEST

Under sterile conditions and at lithotomy position, an urethral and a rectal catheter will be inserted. Bladder will be filled by sterile saline slowly. The first feeling of urine, the first sensation of urination and the sensation of severe desire to urinate will be recorded step by step. Vesical, rectal and detrusor pressures will be monitorized during these period. After the strong desire to void sensation, filling cystometry phase will be completed. Sterile saline infusion is stopped. While the patient urinates the vesical, detrusor and rectal pressures, the maximum and average urine flow rates will be recorded.

Questionnaires DIAGNOSTIC_TEST

Bladder diary is an online application. Frequency, nocturia, functional bladder capacities will be reported. More than 8 urination during daytime will be recorded as overactive bladder. More than 1 interruption of sleep for urination at night is nocturia. Functional bladder capacity below 100 ml will be defined as decreased bladder capacity, while capacity over 400 ml will be reported as increased bladder capacity and compliance.

Uroflowmetry DIAGNOSTIC_TEST

Uroflowmetry test consists measuring the maximum urine flow rate, the average urine flow rate, the micturiated volume and postmictional urine volume. The maximum flow rate below 12 ml/sec in males and 18 ml/sec in females will be recorded as emptying phase disorder. Postvoid residual urine volume above 150 ml is a sign of incomplete emptying of bladder.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Multiple Sclerosis diagnosis less than 5 years

You may qualify if:

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

You may not qualify if:

• Patients who are not eligible for completing questionnaires, bladder diaries.
• Patients who have anatomical disorders preventing lithotomy position during urodynamic study.
• Patients in relapsing period of MS
• Patients who have symptoms of urinary tract infection

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koç University

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ersin Köseoğlu

  Koç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tufan Tarcan

CONTACT

0905434948365; bilgi@tufantarcan.com

Ersin Köseoğlu

CONTACT

0905306930442; ekoseoglu@kuh.ku.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 19, 2022
• Study Start: October 19, 2021
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)