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Electrostimulation in the Treatment of Idiopathic Overactive Bladder

Primary Purpose

Urinary Bladder, Overactive

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electrostimulation
Sponsored by
Janaina Mayer de Oliveira Nunes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Urinary Bladder, Overactive; Electric Stimulation

Eligibility Criteria

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

Inclusion Criteria:

  • Women
  • aged 18 years and over
  • literate
  • exhibit symptoms of overactive bladder (urinary urgency, urge incontinence, nocturia and polaciuria) or mixed urinary incontinence with predominance of urge incontinence
  • to present lower urinary tract dysfunction identified by scores that were equal or higher than 8 points in the Overactive Blader version 8 questionnaire (OAB-V8)
  • accept to participate in the study by means of signing the Term of Free and Informed Consent approved by the Research Ethics Committee of the University Hospital of the Northern Region of Paraná State University of Londrina (HURNP / UEL).

Exclusion Criteria:

  • Women who are virgin
  • pregnant
  • have a recurrent lower urinary tract infection (more than three episodes a year)
  • vaginal infection
  • history of overactive bladder medication in the last three months
  • urinary incontinence to efforts exclusively
  • previous surgery to treat incontinence urinary
  • neurological diseases (such as multiple sclerosis, Alzheimer's disease, stroke, Parkinson's disease)
  • current history of genitourinary neoplasia
  • genital prolapse above third degree of Baden and Walker
  • decompensated diabetic
  • patients with cardiac pacemaker
  • metal implant in the ankle and right foot
  • cognitive deficit that inability to respond to questionnaires properly and / or correctly fill in the voiding diary
  • do not perform all treatment sessions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    vaginal

    posterior tibial nerve

    control

    Arm Description

    Group of volunteers who will be treated with vaginal electrostimulation

    Group treated with transcutaneous electrostimulation of the posterior tibial nerve

    Group of volunteers who will not be treated

    Outcomes

    Primary Outcome Measures

    Change from baseline miccional emergency at 6 weeks after starting treatment and at 1 month after the end of treatment.
    Sudden and uncontrollable desire to urinate checked through the voiding diary.

    Secondary Outcome Measures

    Change from baseline urinary frequency at 6 weeks after starting treatment and at 1 month after the end of treatment.
    Urinating often (more than 8 events / 24h)
    Change from baseline nocturia at 6 weeks after starting treatment and at 1 month after the end of treatment.
    The necessity wake up 1 or more times during the night to urinate.
    Change from baseline urge-incontinence at 6 weeks after starting treatment and at 1 month after the end of treatment.
    Involuntary loss accompanied or preceded by urine in the immediate aftermath of an emergency episode.
    Change from baseline quality of life related to the symptoms of overactive bladder at 6 weeks after starting treatment and at 1 month after the end of treatment.
    The impact of overactive bladder symptoms on the quality of life of the volunteers will be verified through the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB), which is a brief questionnaire with a high psychometric capacity to specifically evaluate overactive bladder. The ICIQ-OAB score ranges from 0 to 16 on a progressive scale, as well as an analog scale from zero to ten to quantify the discomfort caused by each symptom, the higher the score the worse the quality of life.

    Full Information

    First Posted
    April 12, 2018
    Last Updated
    December 10, 2020
    Sponsor
    Janaina Mayer de Oliveira Nunes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03519126
    Brief Title
    Electrostimulation in the Treatment of Idiopathic Overactive Bladder
    Official Title
    Efficacy of Vaginal and Transcutaneous Electrostimulation of the Posterior Tibial Nerve in the Treatment of Overactive Bladder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Terminated
    Why Stopped
    Due to the covid-19 pandemic
    Study Start Date
    April 19, 2016 (Actual)
    Primary Completion Date
    March 30, 2020 (Actual)
    Study Completion Date
    March 30, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Janaina Mayer de Oliveira Nunes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a clinical trial whose objective is to compare the efficacy of transcutaneous electrostimulation of the posterior tibial nerve with intravaginal electrostimulation in the treatment of women with symptoms of idiopathic overactive bladder. The volunteers will be randomly randomized into three study groups: posterior tibial group, vaginal group and control group. They are evaluated at three times: before the start of treatment, at the end of 6 weeks of treatment and after 1 month (follow up). The evaluation will occur through a voiding diary and a quality of life questionnaire. For the treatment groups will be used depolarized biphasic current with frequency of 10 Hz and pulse width of 200 μs, and intensity according to the tolerance of the patient. The hypothesis of the study is that the two forms of electrostimulation for treatment of idiopathic overactive bladder will be effective, but transcutaneous electrostimulation of the posterior tibial nerve will be more effective than intravaginal.
    Detailed Description
    Objective: To compare the efficacy between intravaginal and transcutaneous electrostimulation of the posterior tibial nerve in the treatment of women with symptoms of idiopathic overactive bladder or mixed urinary incontinence. METHODS: This is a randomized, controlled, single-blind clinical trial with comparative analysis between study groups and a control, performed at three moments: pre and post clinical intervention and one month after the end of treatment. Vaginal electrostimulation group (GV), transcutaneous electrostimulation group of the posterior tibial nerve (GTP) and control group (CG - without intervention). The intervention groups will be treated with biphasic current with a frequency of 10 Hz and a pulse width of 200 μs for 12 sessions of 30 minutes each. Participants will be evaluated and reevaluated by means of a general data questionnaire, 3-day urinary diary and an International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB). Statistical analysis will be performed using SPSS version 22 and the level of significance adopted will be p <0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Bladder, Overactive
    Keywords
    Urinary Bladder, Overactive; Electric Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    It is a randomized, controlled, simple blind trial with comparative analysis between study groups and a control, performed in three moments: pre and post clinical intervention and one month after the end of treatment (follow up).
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    vaginal
    Arm Type
    Experimental
    Arm Description
    Group of volunteers who will be treated with vaginal electrostimulation
    Arm Title
    posterior tibial nerve
    Arm Type
    Experimental
    Arm Description
    Group treated with transcutaneous electrostimulation of the posterior tibial nerve
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    Group of volunteers who will not be treated
    Intervention Type
    Other
    Intervention Name(s)
    electrostimulation
    Intervention Description
    Electrostimulation with asymmetric and depolarized biphasic current with a frequency of 10Hz and a pulse width of 200μs.
    Primary Outcome Measure Information:
    Title
    Change from baseline miccional emergency at 6 weeks after starting treatment and at 1 month after the end of treatment.
    Description
    Sudden and uncontrollable desire to urinate checked through the voiding diary.
    Time Frame
    Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
    Secondary Outcome Measure Information:
    Title
    Change from baseline urinary frequency at 6 weeks after starting treatment and at 1 month after the end of treatment.
    Description
    Urinating often (more than 8 events / 24h)
    Time Frame
    Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
    Title
    Change from baseline nocturia at 6 weeks after starting treatment and at 1 month after the end of treatment.
    Description
    The necessity wake up 1 or more times during the night to urinate.
    Time Frame
    Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
    Title
    Change from baseline urge-incontinence at 6 weeks after starting treatment and at 1 month after the end of treatment.
    Description
    Involuntary loss accompanied or preceded by urine in the immediate aftermath of an emergency episode.
    Time Frame
    Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
    Title
    Change from baseline quality of life related to the symptoms of overactive bladder at 6 weeks after starting treatment and at 1 month after the end of treatment.
    Description
    The impact of overactive bladder symptoms on the quality of life of the volunteers will be verified through the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB), which is a brief questionnaire with a high psychometric capacity to specifically evaluate overactive bladder. The ICIQ-OAB score ranges from 0 to 16 on a progressive scale, as well as an analog scale from zero to ten to quantify the discomfort caused by each symptom, the higher the score the worse the quality of life.
    Time Frame
    Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    age greater than or equal to 18 years
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women aged 18 years and over literate exhibit symptoms of overactive bladder (urinary urgency, urge incontinence, nocturia and polaciuria) or mixed urinary incontinence with predominance of urge incontinence to present lower urinary tract dysfunction identified by scores that were equal or higher than 8 points in the Overactive Blader version 8 questionnaire (OAB-V8) accept to participate in the study by means of signing the Term of Free and Informed Consent approved by the Research Ethics Committee of the University Hospital of the Northern Region of Paraná State University of Londrina (HURNP / UEL). Exclusion Criteria: Women who are virgin pregnant have a recurrent lower urinary tract infection (more than three episodes a year) vaginal infection history of overactive bladder medication in the last three months urinary incontinence to efforts exclusively previous surgery to treat incontinence urinary neurological diseases (such as multiple sclerosis, Alzheimer's disease, stroke, Parkinson's disease) current history of genitourinary neoplasia genital prolapse above third degree of Baden and Walker decompensated diabetic patients with cardiac pacemaker metal implant in the ankle and right foot cognitive deficit that inability to respond to questionnaires properly and / or correctly fill in the voiding diary do not perform all treatment sessions

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Electrostimulation in the Treatment of Idiopathic Overactive Bladder

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