Clinical trial NCT05977634: Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
Official title: The Efficacy of Transcutaneous Tibial Nerve Stimulation on Symptoms of Overactive Bladder and Quality of Life in Women With Idiopathic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overactive Bladder
Overactive Bladder Syndrome
Overactive Detrusor
Keywords: tibial nerve stimulation
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder

Detailed description: Idiopathic overactive bladder is defined the presence of a sense of urgency with or without accompanying urinary incontinence without an organic pathology or urinary infection. Its prevalence was reported to be between 7.7 to 31 % in women. In this prospective randomized controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder.

Eligibility criteria: Inclusion Criteria:

* Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than 11.
* Post voiding residue levels less than 100 ml.
* Women aged between 18-70

Exclusion Criteria:

* Prior history of pelvic surgery
* Pelvic organ prolapsus of grade 2 or more.
* Current urinary tract infection

Primary outcomes:
measure: Urination frequency
timeFrame: 1 day
measure: Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire
timeFrame: 1 day
Secondary outcomes:
measure: Quality of life. King's quality of life questionnaire
timeFrame: 1 day
measure: Level of satisfaction with the treatment. Visual analog scale
timeFrame: 1 day
measure: Incontinence impact questionnaire-7.
timeFrame: 1 day
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University School of Medicine
state: Izmir
Study officials:
affiliation: Ege University School of Medicine
name: Ece Cinar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.