Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms

NCT06263556 | Recruiting

• 1 other identifier: 2023/389
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms

Keywords

Multiple Sclerosis; Lower Urinary Track Symptoms; LUTS; Posterior tibial nerve stimulation; TPTNS; TTNS

Outcome Measures

Primary Outcomes (1)

• Incontinence Quality of Life (I-QOL)

  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.

  6 weeks (Before and after the treatment)

Secondary Outcomes (3)

• Post-void residue (PVR)

  6 weeks (Before and after the treatment)

• Bladder diary

  6 weeks (Before and after the treatment)

• International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

  6 weeks (Before and after the treatment)

Study Arms (2)

Pelvic floor exercises and Transcutaneous tibial nerve stimulation

EXPERIMENTAL

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.

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

Pelvic floor exercises and Sham Stimulation

SHAM COMPARATOR

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.

Behavioral: Pelvic floor exercises; Device: Sham stimulation

Interventions

Pelvic floor exercises BEHAVIORAL

Patients will be informed about pelvic floor muscles functions and written material will be given for home training. Exercise program will be planned as 1 set, 3 times per day. Each set will include 10 pelvic floor contractions. Patient will be instructed to squeeze their pelvic muscles and keep them contracted for 8 seconds. Due to fatigue and spasticity patients may experience, patients will set their own resting periods between contractions. Patients will be told to avoid contracting abdominal and gluteal muscles and avoid holding their breathe during the exercise. Patients will be instructed to perform exercise as following: 1. Lie on your back. Take a deep breathe. Relax your abdominal muscles as you breathe out. 2. Focus on your pelvic floor muscles. Squeeze your muscles as you are trying to stop the flow of your urine and stay contracted for 8 seconds, then relax. 3. Repeat when you feel ready. You need to repeat this 10 times. 4. Repeat this exercise 3 times per day

Pelvic floor exercises and Sham Stimulation; Pelvic floor exercises and Transcutaneous tibial nerve stimulation

Transcutaneous posterior tibial nerve stimulation DEVICE

Patients in TTSN group will receive posterior tibial nerve stimulation based on the protocol explained before.

Pelvic floor exercises and Transcutaneous tibial nerve stimulation

Sham stimulation DEVICE

Patients in sham stimulation group will receive sham stimulation based on the protocol explained before.

Pelvic floor exercises and Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (15)

• Kabay SC, Yucel M, Kabay S. Acute effect of posterior tibial nerve stimulation on neurogenic detrusor overactivity in patients with multiple sclerosis: urodynamic study. Urology. 2008 Apr;71(4):641-5. doi: 10.1016/j.urology.2007.11.135.

  PMID: 18387393 BACKGROUND

• Perez DC, Chao CW, Jimenez LL, Fernandez IM, de la Llave Rincon AI. Pelvic floor muscle training adapted for urinary incontinence in multiple sclerosis: a randomized clinical trial. Int Urogynecol J. 2020 Feb;31(2):267-275. doi: 10.1007/s00192-019-03993-y. Epub 2019 Jun 10.

  PMID: 31183535 BACKGROUND

• Celiker Tosun O, Kaya Mutlu E, Ergenoglu AM, Yeniel AO, Tosun G, Malkoc M, Askar N, Itil IM. Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial. Clin Rehabil. 2015 Jun;29(6):525-37. doi: 10.1177/0269215514546768. Epub 2014 Aug 20.

  PMID: 25142280 BACKGROUND

• Booth J, Hagen S, McClurg D, Norton C, MacInnes C, Collins B, Donaldson C, Tolson D. A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care. J Am Med Dir Assoc. 2013 Apr;14(4):270-4. doi: 10.1016/j.jamda.2012.10.021. Epub 2012 Nov 30.

  PMID: 23206722 BACKGROUND

• Sonmez R, Yildiz N, Alkan H. Efficacy of percutaneous and transcutaneous tibial nerve stimulation in women with idiopathic overactive bladder: A prospective randomised controlled trial. Ann Phys Rehabil Med. 2022 Jan;65(1):101486. doi: 10.1016/j.rehab.2021.101486. Epub 2021 Nov 11.

  PMID: 33429090 BACKGROUND

• Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.

  PMID: 15227649 BACKGROUND

• Cetinel B, Ozkan B, Can G. The validation study of ICIQ-SF Turkish version. Turkish J Urol 2004;30(3):332-338.

  BACKGROUND

• Seckiner I, Yesilli C, Mungan NA, Aykanat A, Akduman B. Correlations between the ICIQ-SF score and urodynamic findings. Neurourol Urodyn. 2007;26(4):492-494. doi: 10.1002/nau.20389.

  PMID: 17304520 BACKGROUND

• Wagner TH, Patrick DL, Bavendam TG, Martin ML, Buesching DP. Quality of life of persons with urinary incontinence: development of a new measure. Urology. 1996 Jan;47(1):67-71; discussion 71-2. doi: 10.1016/s0090-4295(99)80384-7.

  PMID: 8560665 BACKGROUND

• Patrick DL, Martin ML, Bushnell DM, Yalcin I, Wagner TH, Buesching DP. Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology. 1999 Jan;53(1):71-6. doi: 10.1016/s0090-4295(98)00454-3.

  PMID: 9886591 BACKGROUND

• Ozerdogan N, Beji NK, Yalcin O. Urinary incontinence: its prevalence, risk factors and effects on the quality of life of women living in a region of Turkey. Gynecol Obstet Invest. 2004;58(3):145-50. doi: 10.1159/000079422. Epub 2004 Jun 29.

  PMID: 15237249 BACKGROUND

• Eyigor S, Karapolat H, Akkoc Y, Yesil H, Ekmekci O. Quality of life in patients with multiple sclerosis and urinary disorders: reliability and validity of Turkish-language version of Incontinence Quality of Life Scale. J Rehabil Res Dev. 2010;47(1):67-71. doi: 10.1682/jrrd.2009.08.0132.

  PMID: 20437328 BACKGROUND

• Groen J, Pannek J, Castro Diaz D, Del Popolo G, Gross T, Hamid R, Karsenty G, Kessler TM, Schneider M, 't Hoen L, Blok B. Summary of European Association of Urology (EAU) Guidelines on Neuro-Urology. Eur Urol. 2016 Feb;69(2):324-33. doi: 10.1016/j.eururo.2015.07.071. Epub 2015 Aug 22.

  PMID: 26304502 BACKGROUND

• Nambiar AK, Bosch R, Cruz F, Lemack GE, Thiruchelvam N, Tubaro A, Bedretdinova DA, Ambuhl D, Farag F, Lombardo R, Schneider MP, Burkhard FC. EAU Guidelines on Assessment and Nonsurgical Management of Urinary Incontinence. Eur Urol. 2018 Apr;73(4):596-609. doi: 10.1016/j.eururo.2017.12.031. Epub 2018 Feb 3.

  PMID: 29398262 BACKGROUND

• Roehrborn CG, Peters PC. Can transabdominal ultrasound estimation of postvoiding residual (PVR) replace catheterization? Urology. 1988 May;31(5):445-9. doi: 10.1016/0090-4295(88)90746-7.

  PMID: 3284155 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sibel CAGLAR

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

• Arda can Kasap

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  STUDY CHAIR

Central Study Contacts

Sibel CAGLAR

CONTACT

+905333365651; dr.sibelcaglar@gmail.com

Arda Can KASAP

CONTACT

+905384590119; drardakasap@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized and assigned to either group.

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 16, 2024
• Study Start: January 17, 2024
• Primary Completion: November 5, 2024
• Study Completion: December 5, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)