Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis; Lower Urinary Tract Symptoms

• Registration Number: NCT06263556
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.

Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS.

Detailed Description

This is a single-centered, prospective, single blind, randomized controlled study of patients with MS who suffer lower urinary track symptoms. All patients will be informed of the details of all the procedures and of the details of the study. After the written informed consent is obtained, patients will be distributed to two equal groups using randomized number table.

At the beginning and end of the study, post-void residue (PVR) will be calculated with ultrasonography, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Quality of Life( I-QOL), 3 day bladder diary (number of urination, urge, incontinence, nocturia) forms will be administered.

Patients will be evaluated via PVR, urodynamic measurements, ICIQ-SF, I-QOL and bladder diary.

Study Timeline

• Study Start: 2024-01-17
• Status Verified: 2024-02
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16
• Primary Completion: 2024-11-05
• Study Completion: 2024-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Volunteer Adults (Age 18-50)
• Diagnosis of Multiple Sclerosis
• Expanded Disability Status Scale (EDSS) 0-6,5
• Lower urinary track symptoms (Urinary incontinence, urgency, nocturia and/or urinary frequency)
• Diagnosis of bladder disfunction with Urodynamic study within 1 months

Exclusion Criteria

• Age less then 18
• Pacemaker or implantable defibrillator usage
• Diabetic polyuria
• Bleeding diathesis or severe bleeding tendency
• Pelvic floor disfunction or nerve damage effecting tibial nerve
• Currently pregnant or planning pregnancy
• Active urinary infection
• Active malignancy
• Severe mental disability
• Cognitive deficit
• Expanded Disability Status Scale (EDSS) greater than or equal to 7
• Unable to attend to TPTNS treatment 2 times a week
• Urodynamic findings of bladder outlet obstruction
• Surgical history because of urinary incontinence
• Urologic surgical history because of lower urinary track disfunction or symptoms
• Diagnosis of prostatic enlargement
• Diagnosis of pelvic organ prolapse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incontinence Quality of Life (I-QOL)	6 weeks (Before and after the treatment)	I-QOL is used for evaluation of quality of life in patients with incontinence. It comprises 22 questions presented under three subscales: limiting behavior, psychosocial impact, and social embarrassment. All the questions are based on a five-point Likert scale (1 = a lot, 2 = quite a bit, 3 = moderate, 4 = a little, and 5 = not at all). Points obtained by each question are added together which results in a total point of 0 to 110. This total point is then recalculated to take a value between 0-100 for better understand. Higher scores indicate a better quality of life. Validation of turkish version is available.

Secondary Outcome Measures

Name	Time	Method
Bladder diary	6 weeks (Before and after the treatment)	2 or 3 day bladder diary is recommended by European Association of Urology in patients with lower urinary track symptoms. Urination frequency, urgency, incontinence and nocturia will be evaluated using 3 day bladder diary.
Post-void residue (PVR)	6 weeks (Before and after the treatment)	Post-void residue (PVR) will be calculated with ultrasonography. Evaluation will be made by same person in all patients after urination, in supine position transabdominally with 2-5 Mhz convex probe using E-Saote Mylab Seven (Italy) device.
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)	6 weeks (Before and after the treatment)	ICIQ-SF allows the assessment of incontinence's severity, frequency and its impact on quality of life. ICIQ-SF scoring is also a practical and reliable method for baseline and post-treatment evaluation of patients with urge incontinence. It contains six questions. First and second questions are about demographics and the sixth question is about conditions that lead to incontinence. First, second and sixth questions have no point value. Total score varies between 0 and 21 and is obtained by adding third, fourth and fifth question's points. Higher scores indicate greater problems with incontinence. Validation of turkish version is available.

Trial Locations

Locations (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital; 🇹🇷 Istanbul, Turkey