Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms
Effectiveness of Transcutaneous Posterior Tibial Nerve Stimulation in Multiple Sclerosis Patients With Lower Urinary Track Symptoms: A Sham Controlled Prospective Randomized Controlled Study
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Transcutaneous posterior tibial nerve stimulation
Placebo
- Sham stimulation
Given to everyone in the trial
- Pelvic floor exercises
What it measured
Main measures
Incontinence Quality of Life (I-QOL)
6 weeks (Before and after the treatment)
Bladder, bowel and sexual functionQuality of life (reported by participants)
Other measures (3)
Post-void residue (PVR)
6 weeks (Before and after the treatment)
Bladder, bowel and sexual functionBladder diary
6 weeks (Before and after the treatment)
Bladder, bowel and sexual functionInternational Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
6 weeks (Before and after the treatment)
Bladder, bowel and sexual functionQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 50 · EDSS 0 to 6
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
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.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.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.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.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.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.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.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.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.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.
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History
Started
Jan 2024
Main results due
Nov 2024
Finished
Dec 2024