Clinical trial NCT06263556: Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms
Official title: Effectiveness of Transcutaneous Posterior Tibial Nerve Stimulation in Multiple Sclerosis Patients With Lower Urinary Track Symptoms: A Sham Controlled Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lower Urinary Tract Symptoms
Keywords: Multiple Sclerosis
Lower Urinary Track Symptoms
LUTS
Posterior tibial nerve stimulation
TPTNS
TTNS
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized and assigned to either group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incontinence Quality of Life (I-QOL)
timeFrame: 6 weeks (Before and after the treatment)
Secondary outcomes:
measure: Post-void residue (PVR)
timeFrame: 6 weeks (Before and after the treatment)
measure: Bladder diary
timeFrame: 6 weeks (Before and after the treatment)
measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
timeFrame: 6 weeks (Before and after the treatment)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study officials:
affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
name: Sibel CAGLAR
role: PRINCIPAL_INVESTIGATOR
affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
name: Arda can Kasap
role: STUDY_CHAIR
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