Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke

Urinary Bladder, Overactive Clinical Trial

Official title:

Efficacy of Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke: A Randomized Placebo-controlled Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385769
• Other study ID #: PamukkaleU.ftr-NYildiz-3
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2024
• Source: Pamukkale University
• Contact: Emre Bezmez, M.D.
• Phone: +905319902220
• Email: emrebezmez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.

The main questions aimed to be answered are:

What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: February 28, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 40 and above with stable ischemic or hemorrhagic stroke.

• Patients with neurogenic detrusor overactivity symptoms accompanied by urinary incontinence complaints and a urinary frequency of 9 or more.

• Patients diagnosed with detrusor overactivity on urodynamic evaluation.

• Patients with hemiplegia lasting between 30 days and 1 year.

• Ability to understand procedures, benefits, and potential side effects.

• Patients scoring 22 or above on the Mini Mental Test.

Exclusion Criteria:

• Patients with post-stroke neurogenic detrusor overactivity receiving or previously received pharmacological treatment.

• Patients using intermittent catheterization or permanent catheterization as a bladder emptying method.

• Patients with a history of urinary incontinence and/or urinary retention before stroke.

• History of past urogynecological surgery.

• Presence of urinary tract infection, bladder tumor, or cardiac pacemaker.

• Significant fluid infusion requirement affecting urination or use of medication affecting bladder function.

• Patients who have received botulinum toxin injection for post-stroke neurogenic detrusor overactivity.

• Patients with postvoid residual volume above 150 mL.

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Other:
• Transcutaneous tibial nerve stimulation (TTNS)
The TTNS will be conducted unilaterally, with the patient in a supine position, using a surface electrode dual stimulation channel stimulation device. Two self-adhesive round surface electrodes will be positioned with the negative electrode 2 cm behind the medial malleolus and the positive electrode 10 cm proximal to it. The ground electrode will be placed on the ipsilateral limb. Channel 1 will provide active stimulation, while channel 2 will remain inactive.
• Sham Transcutaneous tibial nerve stimulation (TTNS)
Sham TTNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the TTNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (20)

Araujo TG, Schmidt AP, Sanches PRS, Silva Junior DP, Rieder CRM, Ramos JGL. Transcutaneous tibial nerve home stimulation for overactive bladder in women with Parkinson's disease: A randomized clinical trial. Neurourol Urodyn. 2021 Jan;40(1):538-548. doi: 10.1002/nau.24595. Epub 2020 Dec 16. — View Citation

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. — View Citation

Culha MG, Degirmentepe RB, Ozbir S, Cakir SS, Homma Y. Turkish validation of the overactive bladder symptom score (OABSS) and evaluation of mirabegron treatment response. Int Urogynecol J. 2019 Dec;30(12):2121-2126. doi: 10.1007/s00192-019-04054-0. Epub 2019 Jul 22. — View Citation

Eftekhar T, Teimoory N, Miri E, Nikfallah A, Naeimi M, Ghajarzadeh M. Posterior tibial nerve stimulation for treating neurologic bladder in women: a randomized clinical trial. Acta Med Iran. 2014;52(11):816-21. — View Citation

Erden E, Ersoz M, Erden E, Tiftik T. Urodynamic findings and therapeutic approaches for neurogenic lower urinary tract dysfunction in patients with thoracic spinal cord injury. Ir J Med Sci. 2023 Oct;192(5):2513-2520. doi: 10.1007/s11845-022-03239-9. Epub 2022 Dec 1. — View Citation

Gaspard L, Tombal B, Opsomer RJ, Castille Y, Van Pesch V, Detrembleur C. [Physiotherapy and neurogenic lower urinary tract dysfunction in multiple sclerosis patients: a randomized controlled trial]. Prog Urol. 2014 Sep;24(11):697-707. doi: 10.1016/j.purol.2014.05.003. Epub 2014 Jun 19. French. — View Citation

Gross T, Schneider MP, Bachmann LM, Blok BF, Groen J, Hoen LA, Castro-Diaz D, Padilla Fernandez B, Del Popolo G, Musco S, Hamid R, Ecclestone H, Karsenty G, Phe V, Pannek J, Kessler TM. Transcutaneous Electrical Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review. Eur Urol. 2016 Jun;69(6):1102-11. doi: 10.1016/j.eururo.2016.01.010. Epub 2016 Jan 29. — View Citation

Hagerty JA, Richards I, Kaplan WE. Intravesical electrotherapy for neurogenic bladder dysfunction: a 22-year experience. J Urol. 2007 Oct;178(4 Pt 2):1680-3; discussion 1683. doi: 10.1016/j.juro.2007.03.188. Epub 2007 Aug 17. — View Citation

Kim SJ, Choi HW, Cho HJ, Hwang TK, Kim JC. The influence of preoperative bladder outlet obstruction on continence and satisfaction in patients with stress urinary incontinence after midurethral sling. Int Neurourol J. 2010 Dec;14(4):267-71. doi: 10.5213/inj.2010.14.4.267. Epub 2010 Dec 31. — View Citation

Kucukdeveci AA, Yavuzer G, Tennant A, Suldur N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92. — View Citation

Liu Y, Xu G, Luo M, Teng HF. Effects of Transcutaneous Electrical Nerve Stimulation at Two Frequencies on Urinary Incontinence in Poststroke Patients: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2016 Mar;95(3):183-93. doi: 10.1097/PHM.0000000000000360. — View Citation

Monteiro ES, de Carvalho LB, Fukujima MM, Lora MI, do Prado GF. Electrical stimulation of the posterior tibialis nerve improves symptoms of poststroke neurogenic overactive bladder in men: a randomized controlled trial. Urology. 2014 Sep;84(3):509-14. doi: 10.1016/j.urology.2014.05.031. — View Citation

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. — View Citation

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. — View Citation

Parittotokkaporn S, Varghese C, O'Grady G, Svirskis D, Subramanian S, O'Carroll SJ. Non-invasive neuromodulation for bowel, bladder and sexual restoration following spinal cord injury: A systematic review. Clin Neurol Neurosurg. 2020 Jul;194:105822. doi: 10.1016/j.clineuro.2020.105822. Epub 2020 Apr 12. — View Citation

Patel M, Coshall C, Rudd AG, Wolfe CD. Natural history and effects on 2-year outcomes of urinary incontinence after stroke. Stroke. 2001 Jan;32(1):122-7. doi: 10.1161/01.str.32.1.122. — View Citation

Perissinotto MC, D'Ancona CA, Lucio A, Campos RM, Abreu A. Transcutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms and its impact on health-related quality of life in patients with Parkinson disease: a randomized controlled trial. J Wound Ostomy Continence Nurs. 2015 Jan-Feb;42(1):94-9. doi: 10.1097/WON.0000000000000078. — View Citation

Schreiner L, dos Santos TG, Knorst MR, da Silva Filho IG. Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Int Urogynecol J. 2010 Sep;21(9):1065-70. doi: 10.1007/s00192-010-1165-6. Epub 2010 May 11. — View Citation

Thomas LH, Watkins CL, French B, Sutton C, Forshaw D, Cheater F, Roe B, Leathley MJ, Burton C, McColl E, Booth J; ICONS Project Team; ICONS Patient, Public and Carer Involvement Group. Study protocol: ICONS: identifying continence options after stroke: a randomised trial. Trials. 2011 May 20;12:131. doi: 10.1186/1745-6215-12-131. — View Citation

Zonic-Imamovic M, Imamovic S, Cickusic A, Delalic A, Hodzic R, Imamovic M. Effects of Treating an Overactive Urinary Bladder in Patients with Multiple Sclerosis. Acta Med Acad. 2019 Dec;48(3):271-277. doi: 10.5644/ama2006-124.267. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased frequency of increased voiding	The effectiveness of the treatment is evaluated based on the daily voiding frequency post-treatment compared to the daily voiding frequency pre-treatment. The expected outcome is a reduction in the frequency of increased voiding.	Change from baseline positive response rate at the 4th week after the treatment
Secondary	Frequency of voiding	The frequency of voiding used will be calculated from the patient's 3-day voiding frequency.	Change from baseline Frequency of voiding, nocturia, number of pads at the 4th week after the treatment
Secondary	The Quality of Life	The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence	Change from baseline the Quality of Life at the 4th week after the treatment
Secondary	Barthel Index for Activities of Daily Living (ADL)	The Barthel Index assesses activities of daily living (ADLs), documenting what a patient does daily without determining capabilities. The 10 items to score are: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation, and stair climbing. Scores reflect independence, with lower scores indicating less independence. A score above 60 typically denotes independence.	Change from baseline Barthel Index for Activities of Daily Living at the 4th week after the treatment
Secondary	The Overactive Bladder Symptom Score (OABSS)	OABSS (Overactive Bladder Symptom Score), four questions assessing daytime frequency (OABSS-1), nocturia frequency (OABSS-2), urgency frequency (OABSS-3), and urgency urinary incontinence (OABSS-4). Severity is rated on a Likert scale from 0-2, 0-3, 0-5, and 0-5, respectively. The total score ranges from 0 to 15, with higher scores indicating more severe symptoms.	Change from baseline The Overactive Bladder Symptom Score at the 4th week after the treatment
Secondary	Treatment Satisfaction Level	At the end of the treatment, participants will be asked to evaluate their satisfaction level with the administered treatment using a Likert scale ranging from 1 to 5 (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, 1=very dissatisfied).	Change from baseline Treatment Satisfaction Level at the 4th week after the treatment
Secondary	Cystometric value	Cystometric value are useful in defining the voiding characteristics of patients.	Change from baseline Cystometric value at the 4th week after the treatment