Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms
NCT ID: NCT06263556
Last Updated: 2024-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2024-01-17
2024-12-05
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pelvic floor exercises and Transcutaneous tibial nerve stimulation
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
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
Transcutaneous posterior tibial nerve stimulation
Patients in TTSN group will receive posterior tibial nerve stimulation based on the protocol explained before.
Pelvic floor exercises and Sham Stimulation
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.
Pelvic floor exercises
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
Sham stimulation
Patients in sham stimulation group will receive sham stimulation based on the protocol explained before.
Interventions
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Pelvic floor exercises
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
Transcutaneous posterior tibial nerve stimulation
Patients in TTSN group will receive posterior tibial nerve stimulation based on the protocol explained before.
Sham stimulation
Patients in sham stimulation group will receive sham stimulation based on the protocol explained before.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital
OTHER_GOV
Responsible Party
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Sibel Caglar Okur
Principal Investigator
Principal Investigators
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Sibel CAGLAR
Role: PRINCIPAL_INVESTIGATOR
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Arda can Kasap
Role: STUDY_CHAIR
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Locations
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Cetinel B, Ozkan B, Can G. The validation study of ICIQ-SF Turkish version. Turkish J Urol 2004;30(3):332-338.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2023/389
Identifier Type: -
Identifier Source: org_study_id
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