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Radiofrequency Non-ablation in the Treatment of Women With Urinary Stress Incontinence: Study Pilot

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tonederm® (Radiofrequency non ablative)
Sponsored by
Centro de Atenção ao Assoalho Pélvico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence focused on measuring urinary incontinence, woman, radiofrequency

Eligibility Criteria

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

Inclusion Criteria:

  • The target audience was made up of women aged between 18 and 65 years with a diagnosis of stress urinary incontinence, referred for physical therapy and who had Pad Test positive criteria by International Continence Society

Exclusion Criteria:

  • Were excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of copper and pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Radiofrequency

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pad test 1 hour (urinary loss)
    The pad test 1 hour is performed following some standard activities to mention the amount of urinary loss, through an absorbent delivered the patients ... after the completion of the activities the absorbent is heavy.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 1, 2015
    Last Updated
    December 7, 2015
    Sponsor
    Centro de Atenção ao Assoalho Pélvico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02623842
    Brief Title
    Radiofrequency Non-ablation in the Treatment of Women With Urinary Stress Incontinence: Study Pilot
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centro de Atenção ao Assoalho Pélvico

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Pilot study, case series conducted in women with a clinical diagnosis of urinary incontinence and were treated with radiofrequency technique for capacitive transfer non ablative in external urethral meatus. All participants did an hour Pad Test. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Tonederm® brand device with capacitive transfer method using non-ablative handle with electrode in the region of the external urethral meatro and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration of 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence
    Keywords
    urinary incontinence, woman, radiofrequency

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiofrequency
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Tonederm® (Radiofrequency non ablative)
    Intervention Description
    The application of RF was performed by physical therapist trained in the technique of radio frequency through the Tonederm® brand device with capacitive transfer method using non-ablative handle with electrode in the region of the external urethral meatro and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration of 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes.
    Primary Outcome Measure Information:
    Title
    Pad test 1 hour (urinary loss)
    Description
    The pad test 1 hour is performed following some standard activities to mention the amount of urinary loss, through an absorbent delivered the patients ... after the completion of the activities the absorbent is heavy.
    Time Frame
    one week, one month, two month , three month and six month measure the urinary loss

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The target audience was made up of women aged between 18 and 65 years with a diagnosis of stress urinary incontinence, referred for physical therapy and who had Pad Test positive criteria by International Continence Society Exclusion Criteria: Were excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of copper and pregnant women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patricia V Lordelo, PhD
    Organizational Affiliation
    Centro de Atenção ao Assoalho Pélvico - BAHIANA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Radiofrequency Non-ablation in the Treatment of Women With Urinary Stress Incontinence: Study Pilot

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