Comparison of the Effects of Transcutaneous Electrical Nerve Stimulation Protocols in Women With Overactive Bladder

Not Applicable

Not yet recruiting

• Conditions: Overactive Bladder
• Interventions: Other: TENS 1; Other: TENS 2

• Registration Number: NCT05672277
• Lead Sponsor: Ankara Yildirim Beyazıt University

Brief Summary

The aim of our study is a comparison of the effects of transcutaneous electrical nerve stimulation (TENS) protocols in women with overactive bladder (OAB).

Detailed Description

OAB is a condition defined by the International Continence Society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. TENS has positive effects on OAB. However, there are not enough studies on how often this stimulation is applied. Studies are needed on this subject.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Last Update Submitted: 2023-01-03
• Study First Posted: 2023-01-05
• Last Update Posted: 2023-01-05
• Study Start: 2023-02-15
• Primary Completion: 2023-06-15
• Study Completion: 2024-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Being in the age range of 18-65 ,
• Having diagnosed with OAB,
• Being a volunteer

Exclusion Criteria

• Being pregnant,
• presence of severe pelvic organ prolapse,
• malignant disease,
• urinary infection,
• neurological disease,
• have electronic and metal implant,
• loss of sensation,
• lumbosacral peripheral nerve lesion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	TENS 1	Group 1 will be applied TENS three days per week
Group 2	TENS 2	Group 2 will be applied TENS one day per week

Primary Outcome Measures

Name	Time	Method
Overactive bladder symptoms	change from baseline at 3 weeks and 6 weeks	Overactive bladder symptoms will be assessed with the Overactive Bladder-V8 Questionnaire

Secondary Outcome Measures

Name	Time	Method
Bladder functions	change from baseline at 3 weeks and 6 weeks	Bladder functions will be assessed with voiding diary
Life quality	change from baseline at 3 weeks and 6 weeks	Life quality will be assessed with the King's Health Questionnaire
Perception of recovery	change from baseline at 3 weeks and 6 weeks	Perception of recovery will be assessed with a 4-point Likert scale
Strength of pelvic floor muscle	change from baseline at 3 weeks and 6 weeks	Strength of pelvic floor muscle will be assessed with Modified Oxford Scale
Urgency severity	change from baseline at 3 weeks and 6 weeks	Urgency severity will be assessed with Patients' Perception of Intensity of Urgency Scale