Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder

NCT05977634 | Active Not Recruiting

• 1 other identifier: Ege 19-12.3/5
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Overactive Bladder; Overactive Detrusor; Overactive Bladder Syndrome

Keywords

tibial nerve stimulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Quality of life. King's quality of life questionnaire

  1 day

• Level of satisfaction with the treatment. Visual analog scale

  1 day

• Incontinence impact questionnaire-7.

  1 day

Study Arms (2)

Transcutaneous tibial nerve stimulation plus bladder training

EXPERIMENTAL

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.

Behavioral: Bladder training; Device: Transcutaneous tibial nerve stimulation

Bladder training

OTHER

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.

Behavioral: Bladder training

Interventions

Bladder training BEHAVIORAL

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

Bladder training; Transcutaneous tibial nerve stimulation plus bladder training

Transcutaneous tibial nerve stimulation DEVICE

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.

Transcutaneous tibial nerve stimulation plus bladder training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Only biological females will be enrolled in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University School of Medicine

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Related 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.

  PMID: 27921161 BACKGROUND

• 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.

  PMID: 30311692 BACKGROUND

• 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.

  PMID: 25623739 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ece Cinar, MD

  Ege University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessor and investigator that assesses the patients will be blind to the study groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: September 30, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)