Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder

Not Applicable

Not yet recruiting

• Conditions: Overactive Detrusor; Overactive Bladder Syndrome; Overactive Bladder
• Interventions: Behavioral: Bladder training; Device: Transcutaneous tibial nerve stimulation

• Registration Number: NCT05977634
• Lead Sponsor: Ege University

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.

Study Timeline

• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Study Start: 2023-09-30
• Primary Completion: 2026-07-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcutaneous tibial nerve stimulation plus bladder training	Transcutaneous tibial nerve stimulation	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.
Transcutaneous tibial nerve stimulation plus bladder training	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.
Bladder training	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.

Primary Outcome Measures

Name	Time	Method
Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire	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	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 Outcome Measures

Name	Time	Method
Quality of life. King's quality of life questionnaire	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.
Level of satisfaction with the treatment. Visual analog scale	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.
Incontinence impact questionnaire-7.	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.

Trial Locations

Locations (1)

Ege University School of Medicine; 🇹🇷 Bornova, Izmir, Turkey