Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
NCT ID: NCT05977634
Last Updated: 2023-09-07
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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NOT_YET_RECRUITING
NA
26 participants
INTERVENTIONAL
2023-09-30
2026-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Transcutaneous tibial nerve stimulation plus bladder training
Patients will receive transcutaneous tibial nerve stimulation for 30 minutes, twice a week, for 6 weeks. Application will be done in an outpatient setting, using disposable surface electrodes.
Bladder training
Bladder training has 4 components, educating the patient about anatomy, fluid intake control, pelvic floor muscle contractions and increasing the interval between visits to the bathroom
Transcutaneous tibial nerve stimulation
A combined electrotherapy device capable of applying transcutaneous electrical nerve stimulation will be used. Each session will take 30 minutes. Patient will visit the hospital twice a week for 6 weeks. An electrical current of 0-50 amperes with a frequency of 20 herz, and a duration of 200 micro seconds will be applied using 50x50 mm surface electordes. The aim is to create a tingling sensation without causing any pain on the tibial nerve, at the ankle level.
Bladder training
patients will receive only the routine education program that is given to every patient with idiopathic overactive bladder syndrome. This includes education about the anatomy of the urinary system, patient motivation, and frequent bathroom visits in order to avoid incontinence with gradual increase between each visit to the bathroom.
Bladder training
Bladder training has 4 components, educating the patient about anatomy, fluid intake control, pelvic floor muscle contractions and increasing the interval between visits to the bathroom
Interventions
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Bladder training
Bladder training has 4 components, educating the patient about anatomy, fluid intake control, pelvic floor muscle contractions and increasing the interval between visits to the bathroom
Transcutaneous tibial nerve stimulation
A combined electrotherapy device capable of applying transcutaneous electrical nerve stimulation will be used. Each session will take 30 minutes. Patient will visit the hospital twice a week for 6 weeks. An electrical current of 0-50 amperes with a frequency of 20 herz, and a duration of 200 micro seconds will be applied using 50x50 mm surface electordes. The aim is to create a tingling sensation without causing any pain on the tibial nerve, at the ankle level.
Eligibility Criteria
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Inclusion Criteria
* Post voiding residue levels less than 100 ml.
* Women aged between 18-70
Exclusion Criteria
* Pelvic organ prolapsus of grade 2 or more.
* Current urinary tract infection
18 Years
70 Years
FEMALE
No
Sponsors
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Ege University
OTHER
Responsible Party
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Ece Cinar
Assistant Professor
Principal Investigators
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Ece Cinar, MD
Role: PRINCIPAL_INVESTIGATOR
Ege University School of Medicine
Locations
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Ege University School of Medicine
Bornova, İzmir, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.
Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12.
Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23.
Other Identifiers
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Ege 19-12.3/5
Identifier Type: -
Identifier Source: org_study_id
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