Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status: Enrolling

Conditions: Lower Urinary Tract Symptoms; Multiple Sclerosis

Treatments: Device: Transcutaneous posterior tibial nerve stimulation; Behavioral: Pelvic floor exercises; Device: Sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06263556

2023/389

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Pelvic floor exercises and Transcutaneous tibial nerve stimulation

Experimental group

Description:

Patients in this group will receive pelvic floor exercise program as described before and transcutaneous tibial nerve stimulation (TTNS). The intervention will comprise 12 session of transcutaneous tibial nerve stimulation (Twice a week, for 6 continuous weeks). Each session will last 30 minutes. Two self adhesive surface electrodes will be positioned according to the protocol used by Booth et al and Sonmez et al, with the negative electrode 2 cm behind the medial malleolus, and positive electrode 10 cm proximal to it. Correct positioning will be determined by noting a hallux reaction (plantar flexion of great toe). Stimulation will be delivered at fixed frequency of 20 Hz and pulse width of 200 ms. The intensity level of the stimulation current (range 0-50 mA) will be determined once hallux reaction is observed, according to patient's tolerance.

Treatment:

Behavioral: Pelvic floor exercises

Device: Transcutaneous posterior tibial nerve stimulation

Pelvic floor exercises and Sham Stimulation

Sham Comparator group

Description:

Patients in this group will receive pelvic floor exercise program as described before and Sham stimulation. The intervention will comprise 12 session of sham stimulation. (Twice a week, for 6 continuous weeks) Each session will last 30 minutes. Two self adhesive surface electrodes will be positioned According to the protocol used by Booth et al, with the negative electrode 2 cm behind the lateral malleolus, and positive electrode 10 cm proximal to it, therefore avoiding the posterior tibial nerve. The stimulation current will be reduced to 2 mA once the tingling sensation is obtained and patients will be informed that they may not feel electrical sensation during the session. Stimulation will be delivered at fixed frequency of 20 Hz and pulse width of 200 ms. If willing, patients in this group will receive TTNS treatment after the study is completed.

Treatment:

Device: Sham stimulation

Behavioral: Pelvic floor exercises