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
About this trial
This is an interventional supportive care trial for Urinary Incontinence focused on measuring urinary incontinence, woman, radiofrequency
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
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
NCT ID
NCT02623842
First Posted
December 1, 2015
Last Updated
December 7, 2015
Sponsor
Centro de Atenção ao Assoalho Pélvico
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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