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Clinical Trials/NCT05977634
NCT05977634
Active, Not Recruiting
N/A

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

Ege University2 sites in 2 countries26 target enrollmentSeptember 30, 2023

Overview

Phase
N/A
Intervention
Bladder training
Conditions
Overactive Bladder
Sponsor
Ege University
Enrollment
26
Locations
2
Primary Endpoint
Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire
Status
Active, Not Recruiting
Last Updated
23 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2023
End Date
August 30, 2026
Last Updated
23 days ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ece Cinar

Assistant Professor

Ege University

Eligibility Criteria

Inclusion Criteria

  • Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than
  • 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

Arms & Interventions

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.

Intervention: Bladder training

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.

Intervention: Transcutaneous tibial nerve stimulation

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.

Intervention: Bladder training

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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 Sites (2)

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