Neurogenic Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Optimal Diagnostic Algorithm for Neurogenic Lower Urinary Tract Symptoms in Patients With MS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587101
• Other study ID #: KocUrol
• Status: Recruiting
• Start date: October 19, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2022
• Source: Koç University
• Contact: Tufan Tarcan
• Phone: 0905434948365
• Email: bilgi[@]tufantarcan.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Multiple Sclerosis
• Neurogenic Bladder
• Sclerosis
• Urinary Bladder, Neurogenic

Intervention

Diagnostic Test:
• Urodynamic Study (Filling cystometry and pressure-flow study)
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
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
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.

Locations

Country	Name	City	State
Turkey	Koç University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Questionnaire Scores	Bladder dysfunction	every 3 months
Primary	Changes in Urodynamics	Bladder dysfunction	every 3 months