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NCT Number: NCT05977634

Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ege University School of Medicine

Bornova, İzmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Urination frequency

    Time frame: 1 day

    The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period.

  2. Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire

    Time frame: 1 day

    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.

Secondary outcomes

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

    Time frame: 1 day

    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.

  2. Level of satisfaction with the treatment. Visual analog scale

    Time frame: 1 day

    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.

  3. Incontinence impact questionnaire-7.

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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