Radiofrequency in the Female Stress Urinary Incontinence

June 21, 2023 updated by: Centro de Atenção ao Assoalho Pélvico

Radiofrequency in the Female Stress Urinary Incontinence: A Randomized Clinical Trial

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Ba
      • Salvador, Ba, Brazil, 40.290-000
        • Recruiting
        • Centro de Atenção ao assoalho pélvico
        • Contact:
        • Principal Investigator:
          • Patricia V Lordelo, Phd
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency
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.
Device: Radiofrequency
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
Sham Comparator: Radiofrequency Off
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.
Device: Radiofrequency OFF
Will be used to put off radio frequency will be heated glycerin to occur masking for the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary loss modification
Time Frame: one week, one month, two month , three month and six month
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.
one week, one month, two month , three month and six month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall quality of life
Time Frame: one week
Will be evaluated before and after radio frequency the overall quality of life - SF-36 - questionaire.
one week
specific Quality of life
Time Frame: one week
The quality of life will be assessed by one for specific urinary symptoms - Health King , measure with unit of the scale
one week
Sexual Function
Time Frame: one week
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.
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Atenção ao Assoalho Pélvico

Investigators

  • Principal Investigator: Patricia Lordelo, PhD, Centro de Atenção ao Assoalho Pélvico - BAHIANA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 22, 2015

First Submitted That Met QC Criteria

November 26, 2015

First Posted (Estimated)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1162-0945

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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