Multiple Sclerosis and Overactive Bladder Treatment

NCT05312138 | Completed

• 1 other identifier: patak
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary symptoms are frequently seen in patients with Multiple Sclerosis (MS). Early evaluation of the patients in terms of the urinary system, planning the appropriate treatment and following up at regular intervals are extremely important in terms of preventing urinary system complications. Neuromodulation applications are used reliably in the urological treatment of MS patients. The aim of this study was to compare the efficacy of different neuromodulation techniques, transcutaneous posterior tibial nerve stimulation and repetitive transcranial magnetic stimulation, in patients with MS reporting lower urinary tract symptoms.

Conditions

Neurogenic Bladder Dysfunction

Keywords

Multiple Sclerosis; Overactive Bladder; Neurogenic Bladder; Electrical stimulation

Outcome Measures

Primary Outcomes (6)

• Urodynamics Test

  While the bladder is being filled, it will be carried out to measure the pressures in the bladder and in the abdomen, to examine the nerves that provide bladder contractions, and to explain the cases of urinary incontinence or inability by examining the bladder contraction pressures and electrical activity during urination.

  "10 days" the amount of change after 10 days from the baseline

• Extended Disability Status Scale (EDSS)

  It is the most commonly used scale to assess disability in MS. EDSS scoring is based on the neurological examination results of eight functional systems and the patient's ambulation status. Functional systems are listed as pyramidal, cerebellar, brainstem, sensory, bladder and intestinal, visual, cerebral, and others. A score of 0-10 is given.0 denotes normal neurological examination, 10 denotes death due to MS. 1.0-4.5 refers to fully ambulatory, 5.0-9.5 refers to impaired ambulation. From 7.0 onwards there is wheelchair use and increasingly bed dependency.

  "10 days" the amount of change after 10 days from the baseline

• Overactive Bladder Questionnaire-V8 (OAB-V8)

  The severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and too many (5) it consists of 8 questions that can be graded. The total score can vary between 0 and 40.

  "10 days" the amount of change after 10 days from the baseline

• Incontinence Quality of Life -I-QOL

  It consists of a total of 22 questions with three sub-dimensions. Sub-dimensions; limitation of behaviors (1,2,3,4,10,11,13,20 items), psychosocial influence (5,6,7,9,15,16,17,21,22 items) and social isolation (8,12 ,14,18,19 items). All items are evaluated with a five-point Likert type (1= too much, 2= a quite, 3= moderately, 4= a little, 5= not at all) and the Likert types are recalculated to take a value between 0-100 points in order to better understand the total score calculated. Higher scores indicate better quality of life.

  "10 days" the amount of change after 10 days from the baseline

• Voiding Diary

  It is recommended to present the information given by the patients in an objective way. Although not entirely diagnostic, diary data can reveal normal and abnormal conditions. The 3-day voiding diary is a viable, reliable and valid tool in the evaluation of patients with lower urinary tract symptoms.

  "10 days" the amount of change after 10 days from the baseline

• Incontinence Severity Index (ISI)

  It consists of 2 questions, and the total score is obtained by multiplying the frequency of urinary incontinence and the amount of urine leaked, and the score range varies between 1-12. According to their score, 1-2 points are light; 3-6 points average; 8-9 points indicate severe and 12 points very severe urinary incontinence.

  "10 days" the amount of change after 10 days from the baseline

Study Arms (2)

Transcutaneous Posterior Tibial Nerve Stimulation Group

EXPERIMENTAL

The treatment will be carried out by the physiotherapist using the TenStem Eco Basic device.

Device: Transcutaneous Posterior Tibial Nerve Stimulation

Repetitive Transcranial Magnetic Stimulation Group

ACTIVE COMPARATOR

The treatment will be applied with a Power Mag device.

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

The treatment will be internally cooled 70 mm double coil and 110 mm round coil, accompanied by a physiotherapist and neurologist. The coil will be placed on the precentral gyrus. Practices will be held, with each session lasting 20 minutes. Cortical excitability will be provided by high frequency (HF) stimulation (5-Hz).

Repetitive Transcranial Magnetic Stimulation Group

Transcutaneous Posterior Tibial Nerve Stimulation DEVICE

The treatment parameters will be applied with a pulse current time of 200 μsec, a fixed frequency of 10 Hz, a treatment time of 20 minutes, and a current intensity that the patient can tolerate, which will not cause flexion in the big toe or fan movement in the other fingers. Self-adhesive surface electrodes will be used for stimulation. During the treatment, the patient will lie on his back. The negative electrode will be placed 2 cm posterior to the medial malleolus and the positive electrode will be placed 10 cm proximal.

Transcutaneous Posterior Tibial Nerve Stimulation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Woman
• Volunteer to participate in the study
• Neurogenic overactive bladder due to MS
• EDSS \<7.0
• Not benefiting from pharmacological treatment

You may not qualify if:

• With urinary tract infection
• Diagnosed with diabetes mellitus
• Using diuretic medication
• Using clean intermittent catheterization
• Having a history of different urological diseases
• Those who have conditions that would be contraindicated for electrical stimulation (pacemaker, brain pacemaker, prosthesis)

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• Nardone R, Versace V, Sebastianelli L, Brigo F, Golaszewski S, Christova M, Saltuari L, Trinka E. Transcranial magnetic stimulation and bladder function: A systematic review. Clin Neurophysiol. 2019 Nov;130(11):2032-2037. doi: 10.1016/j.clinph.2019.08.020. Epub 2019 Sep 3.

  PMID: 31541980 BACKGROUND

• de Seze M, Raibaut P, Gallien P, Even-Schneider A, Denys P, Bonniaud V, Game X, Amarenco G. Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study. Neurourol Urodyn. 2011 Mar;30(3):306-11. doi: 10.1002/nau.20958. Epub 2011 Feb 8.

  PMID: 21305588 BACKGROUND

• Abboud H, Hill E, Siddiqui J, Serra A, Walter B. Neuromodulation in multiple sclerosis. Mult Scler. 2017 Nov;23(13):1663-1676. doi: 10.1177/1352458517736150.

  PMID: 29115915 BACKGROUND

• Fingerman JS, Finkelstein LH. The overactive bladder in multiple sclerosis. J Am Osteopath Assoc. 2000 Mar;100(3 Suppl):S9-12.

  PMID: 10763312 BACKGROUND

• Atak Cakir P, Guzelburc V, Birday E, Hanoglu L, Mutluay F. Effect of neuromodulation on neurogenic bladder in women with multiple sclerosis: a pilot randomized controlled trial. Neurodegener Dis Manag. 2025 Apr-Jun;15(2-3):57-64. doi: 10.1080/17582024.2025.2488712. Epub 2025 Apr 11.

  PMID: 40211880 DERIVED

• Atak Cakir P, Mutluay F, Hanoglu L, Guzelburc V. Effect of transcutaneous posterior tibial nerve stimulation and repetitive transcranial magnetic stimulation on neurogenic overactive bladder symptoms in female patients with multiple sclerosis: The study protocol of a randomized controlled study. Front Neurol. 2022 Oct 28;13:1011502. doi: 10.3389/fneur.2022.1011502. eCollection 2022.

  PMID: 36388236 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Overactive; Urinary Bladder, Neurogenic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Pınar Atak Çakır

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: April 5, 2022
• Study Start: June 8, 2021
• Primary Completion: October 8, 2022
• Study Completion: December 7, 2022
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)