Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms

Last updated: February 9, 2024
Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Interstitial Cystitis

Multiple Sclerosis

Treatment

Pelvic floor exercises

Transcutaneous posterior tibial nerve stimulation

Sham stimulation

Clinical Study ID

NCT06263556
2023/389
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 urinaryfrequency)
  • Diagnosis of bladder disfunction with Urodynamic study within 1 months

Exclusion

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

Total Participants: 64
Treatment Group(s): 3
Primary Treatment: Pelvic floor exercises
Phase:
Study Start date:
January 17, 2024
Estimated Completion Date:
December 05, 2024

Study 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.

Connect with a study center

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    Istanbul,
    Turkey

    Active - Recruiting

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