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Radiofrequency in the Female Stress Urinary Incontinence

Primary Purpose

Urinary Stress Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Radiofrequency
Radiofrequency OFF
Sponsored by
Centro de Atenção ao Assoalho Pélvico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring Urinary Stress Incontinence, Radiofrequency, Women

Eligibility Criteria

18 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 21 Women with age between 18-59 years old,
  • women with diagnosis of urinary incontinence and have a Pelvic floor muscle contractility was assessed by digital palpation using the validated Modified Oxford Scale (MOS) greater than or equal to three

Exclusion Criteria:

  • Patients with cognitive deficits or psychiatric illness;
  • suffering from chronic degenerative neurological diseases; which have greater than 50 ml post-voiding residue ;
  • sensory deficit in the genital region;
  • people with pacemakers and implantable cardioverter-defibrillator and pregnant women will be excluded from the study

Sites / Locations

  • Centro de Atenção ao Assoalho PelvicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Radiofrequency

Radiofrequency Off

Arm Description

Experimental group: women with urinary incontinence are subjected to standard treatment kinesiotherapy perineal ( pelvic muscle exercises ) every day in home and one session per week in the clinic in beyond the RF application in the genital area once a week to total 5 sessions.

Control group: women with stress urinary incontinence will be submitted to the treatment of kinesiotherapy standard perineal ( pelvic muscle exercises ) every day in home and one session per week in the clinic beyond the application of radiofrequency off in genital area once a week with the total of 5 sessions.

Outcomes

Primary Outcome Measures

Urinary loss modification
The pad test will be held at the beginning of treatment and one week, one month, two month, three month and six month after the last session of radio frequency. The pad test it quantifies in grams urinary loss through the absorbent weighing.

Secondary Outcome Measures

specific Quality of life
The quality of life will be assessed by one for specific urinary symptoms - Health King , measure with unit of the scale
Sexual Function
Will be evaluated before and after radio frequency sexual function of women, through questionary FSFI in which there is a switching station which evaluates the presence of sexual dysfunction, and there is specific scores for the domains of pain, desire, lubrication, arousal, orgasm, and satisfaction.
overall quality of life
Will be evaluated before and after radio frequency the overall quality of life - SF-36 - questionaire.

Full Information

First Posted
November 22, 2015
Last Updated
June 21, 2023
Sponsor
Centro de Atenção ao Assoalho Pélvico
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1. Study Identification

Unique Protocol Identification Number
NCT02617797
Brief Title
Radiofrequency in the Female Stress Urinary Incontinence
Official Title
Radiofrequency in the Female Stress Urinary Incontinence: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

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
Urinary stress incontinence ( SUI ) is defined as an involuntary loss of urinary Complaint no effort According to the Consensus of the International Continence Society (Society Continence International - ICS) . SUI Prevalence of adult female Population and 25 % to 30 %.However, despite the high prevalence, many women who have symptoms of SUI or not seek treatment remain without resolution of symptoms.Then there is the possibility of using non-invasive radiofrequency and non-ablation in external urethral meatus in order to stimulate collagen production, as one of the pathophysiological mechanisms of stress urinary incontinence is the collagen deficit in the urethral wall. It is a randomized clinical trial and the group experimental will utilize radiofrequency and kinesiotheraphy ( clinical and in home) and the group control utilize turn off- radiofrequency and kinesiotherapy (clinical and in home). The protocol f the kinesiotherapy is the same both the group, and the protocol radiofrequency the group experimental will 5 sessions (one per week) with temperature 38ºC during 2 minutes. The group control will 5 sessions (one per week) but the radiofrequency will off but glycerin is heated, for masking for the patient, during 2 min. The result of the treatment is assessed by pad test 1 hour and have others outcomes ( quality of life- Sf-26 ans King Health- and sexual function- FSFI questionaire)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
Urinary Stress Incontinence, Radiofrequency, Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency
Arm Type
Experimental
Arm Description
Experimental group: women with urinary incontinence are subjected to standard treatment kinesiotherapy perineal ( pelvic muscle exercises ) every day in home and one session per week in the clinic in beyond the RF application in the genital area once a week to total 5 sessions.
Arm Title
Radiofrequency Off
Arm Type
Sham Comparator
Arm Description
Control group: women with stress urinary incontinence will be submitted to the treatment of kinesiotherapy standard perineal ( pelvic muscle exercises ) every day in home and one session per week in the clinic beyond the application of radiofrequency off in genital area once a week with the total of 5 sessions.
Intervention Type
Device
Intervention Name(s)
Radiofrequency
Intervention Description
The radiofrequency is a noninvasive technique that will be applied to the external urethral meatus region.It will use a digital thermometer with infrared to mention the temperature should reach 39 ° C and maintain this temperature for 2 minutes.It will use a digital thermometer with infrared to mention the temperature should reach 39 ° C and maintain this temperature for 2 minutes
Intervention Type
Device
Intervention Name(s)
Radiofrequency OFF
Intervention Description
Will be used to put off radio frequency will be heated glycerin to occur masking for the patient.
Primary Outcome Measure Information:
Title
Urinary loss modification
Description
The pad test will be held at the beginning of treatment and one week, one month, two month, three month and six month after the last session of radio frequency. The pad test it quantifies in grams urinary loss through the absorbent weighing.
Time Frame
one week, one month, two month , three month and six month
Secondary Outcome Measure Information:
Title
specific Quality of life
Description
The quality of life will be assessed by one for specific urinary symptoms - Health King , measure with unit of the scale
Time Frame
one week
Title
Sexual Function
Description
Will be evaluated before and after radio frequency sexual function of women, through questionary FSFI in which there is a switching station which evaluates the presence of sexual dysfunction, and there is specific scores for the domains of pain, desire, lubrication, arousal, orgasm, and satisfaction.
Time Frame
one week
Title
overall quality of life
Description
Will be evaluated before and after radio frequency the overall quality of life - SF-36 - questionaire.
Time Frame
one week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 21 Women with age between 18-59 years old, women with diagnosis of urinary incontinence and have a Pelvic floor muscle contractility was assessed by digital palpation using the validated Modified Oxford Scale (MOS) greater than or equal to three Exclusion Criteria: Patients with cognitive deficits or psychiatric illness; suffering from chronic degenerative neurological diseases; which have greater than 50 ml post-voiding residue ; sensory deficit in the genital region; people with pacemakers and implantable cardioverter-defibrillator and pregnant women will be excluded from the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia V Lordelo, Phd
Phone
+5571988592400
Email
pvslordelo@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Lordelo, PhD
Organizational Affiliation
Centro de Atenção ao Assoalho Pélvico - BAHIANA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Atenção ao Assoalho Pelvico
City
Salvador
State/Province
Ba
ZIP/Postal Code
40.290-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina A Brasil, Ba
Phone
+5571987929440
Email
tinaabrasil@hotmail.com
First Name & Middle Initial & Last Name & Degree
Patricia V Lordelo, Phd
Phone
+5571988592400
Email
pvslordelo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Patricia V Lordelo, phd

12. IPD Sharing Statement

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Radiofrequency in the Female Stress Urinary Incontinence

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