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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Post-void residue (PVR) | Post-void residue (PVR) will be calculated with ultrasonography. Evaluation will be made by same person in all patients after urination, in supine position transabdominally with 2-5 Mhz convex probe using E-Saote Mylab Seven (Italy) device. | 6 weeks (Before and after the treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sibel CAGLAR | Contact | +905333365651 | dr.sibelcaglar@gmail.com | |
| Arda Can KASAP | Contact | +905384590119 | drardakasap@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakirkoy Dr. Sadi Konuk Research and Training Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18387393 | 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. | |
| 31183535 | 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. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Patients will be randomized and assigned to either group.
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|
| Transcutaneous posterior tibial nerve stimulation | Device | Patients in TTSN group will receive posterior tibial nerve stimulation based on the protocol explained before. |
|
| Sham stimulation | Device | Patients in sham stimulation group will receive sham stimulation based on the protocol explained before. |
|
| Bladder diary |
2 or 3 day bladder diary is recommended by European Association of Urology in patients with lower urinary track symptoms. Urination frequency, urgency, incontinence and nocturia will be evaluated using 3 day bladder diary. |
| 6 weeks (Before and after the treatment) |
| International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) | ICIQ-SF allows the assessment of incontinence's severity, frequency and its impact on quality of life. ICIQ-SF scoring is also a practical and reliable method for baseline and post-treatment evaluation of patients with urge incontinence. It contains six questions. First and second questions are about demographics and the sixth question is about conditions that lead to incontinence. First, second and sixth questions have no point value. Total score varies between 0 and 21 and is obtained by adding third, fourth and fifth question's points. Higher scores indicate greater problems with incontinence. Validation of turkish version is available. | 6 weeks (Before and after the treatment) |
| 25142280 | 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. |
| 23206722 | 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. |
| 33429090 | 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. |
| 15227649 | 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 | Cetinel B, Ozkan B, Can G. The validation study of ICIQ-SF Turkish version. Turkish J Urol 2004;30(3):332-338. |
| 17304520 | 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. |
| 8560665 | 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. |
| 9886591 | 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. |
| 15237249 | 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. |
| 20437328 | 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. |
| 26304502 | 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. |
| 29398262 | 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. |
| 3284155 | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |