Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

The Efficacy of Transcutaneous Tibial Nerve Stimulation on Symptoms of Overactive Bladder and Quality of Life in Women With Idiopathic Overactive Bladder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05977634
• Other study ID #: Ege 19-12.3/5
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: September 2023
• Source: Ege University
• Contact: Ece Cinar, MD
• Phone: 00905372257018
• Email: ece.cinar[@]ege.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: August 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Overactive Bladder Syndrome
• Overactive Detrusor
• Urinary Bladder, Overactive

Intervention

Behavioral:
• 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

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Ege University School of Medicine	Bornova	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urination frequency	The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period.	1 day
Primary	Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire	This questionnaire assesses the severity of overactive bladder symptoms in 8 items. Each item is scored from 0 to 5. Higher scores denote worse symptom severity. Maximum score is 40. A score over 11 denotes presence of overactive bladder symptoms. Questionnaire will be answered before and after the treatment period.	1 day
Secondary	Quality of life. King's quality of life questionnaire	This questionnaire includes a total of 19 questions assessing general quality of life and also questions related to urinary symptoms. Maximum score is 100 and higher scores denote lower levels of quality of life. Questionnaire will be answered before and after the treatment period.	1 day
Secondary	Level of satisfaction with the treatment. Visual analog scale	After the completion of the study period, patients will be asked to assess their levels of satisfaction with the treatment they received on a visual analog scale.	1 day
Secondary	Incontinence impact questionnaire-7.	This 7 item questionnaire assesses the impact of urinary incontinence on the patients' daily lives. Maximum score is 100. Higher scores denote worse outcomes. Questionnaire will be answered before and after the treatment period.	1 day