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

Primary Purpose

Overactive Bladder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TENS 1
TENS 2
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    Group 1 will be applied TENS three days per week

    Group 2 will be applied TENS one day per week

    Outcomes

    Primary Outcome Measures

    Overactive bladder symptoms
    Overactive bladder symptoms will be assessed with the Overactive Bladder-V8 Questionnaire

    Secondary Outcome Measures

    Urgency severity
    Urgency severity will be assessed with Patients' Perception of Intensity of Urgency Scale
    Bladder functions
    Bladder functions will be assessed with voiding diary
    Life quality
    Life quality will be assessed with the King's Health Questionnaire
    Strength of pelvic floor muscle
    Strength of pelvic floor muscle will be assessed with Modified Oxford Scale
    Perception of recovery
    Perception of recovery will be assessed with a 4-point Likert scale

    Full Information

    First Posted
    January 3, 2023
    Last Updated
    January 3, 2023
    Sponsor
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05672277
    Brief Title
    Comparison of the Effects of Transcutaneous Electrical Nerve Stimulation Protocols in Women With Overactive Bladder
    Official Title
    Comparison of the Effects of Transcutaneous Electrical Nerve Stimulation Protocols in Women With Overactive Bladder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2023 (Anticipated)
    Primary Completion Date
    June 15, 2023 (Anticipated)
    Study Completion Date
    February 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Yildirim Beyazıt University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overactive Bladder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Group 1 will be applied TENS three days per week
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Group 2 will be applied TENS one day per week
    Intervention Type
    Other
    Intervention Name(s)
    TENS 1
    Intervention Description
    Parasacral TENS will be applied for 30 minutes 3 days a week during 6 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    TENS 2
    Intervention Description
    Parasacral TENS will be applied for 30 minutes one day a week during 6 weeks.
    Primary Outcome Measure Information:
    Title
    Overactive bladder symptoms
    Description
    Overactive bladder symptoms will be assessed with the Overactive Bladder-V8 Questionnaire
    Time Frame
    change from baseline at 3 weeks and 6 weeks
    Secondary Outcome Measure Information:
    Title
    Urgency severity
    Description
    Urgency severity will be assessed with Patients' Perception of Intensity of Urgency Scale
    Time Frame
    change from baseline at 3 weeks and 6 weeks
    Title
    Bladder functions
    Description
    Bladder functions will be assessed with voiding diary
    Time Frame
    change from baseline at 3 weeks and 6 weeks
    Title
    Life quality
    Description
    Life quality will be assessed with the King's Health Questionnaire
    Time Frame
    change from baseline at 3 weeks and 6 weeks
    Title
    Strength of pelvic floor muscle
    Description
    Strength of pelvic floor muscle will be assessed with Modified Oxford Scale
    Time Frame
    change from baseline at 3 weeks and 6 weeks
    Title
    Perception of recovery
    Description
    Perception of recovery will be assessed with a 4-point Likert scale
    Time Frame
    change from baseline at 3 weeks and 6 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Women with overactive bladder
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seyda Toprak Celenay
    Phone
    +90312 906 1000
    Email
    sydtoprak@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seyda Toprak Celenay
    Organizational Affiliation
    Ankara Yildirim Beyazıt University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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