Radiofrequency in the Female Stress Urinary Incontinence

NCT ID: NCT02617797

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2025-06-30

Brief Summary

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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)

Detailed Description

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Conditions

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Urinary Stress Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Radiofrequency

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Radiofrequency OFF

Intervention Type DEVICE

Will be used to put off radio frequency will be heated glycerin to occur masking for the patient.

Interventions

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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

Intervention Type DEVICE

Radiofrequency OFF

Will be used to put off radio frequency will be heated glycerin to occur masking for the patient.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centro de Atenção ao Assoalho Pélvico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Lordelo, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro de Atenção ao Assoalho Pélvico - BAHIANA

Locations

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Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Patricia V Lordelo, Phd

Role: CONTACT

+5571988592400

Facility Contacts

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Cristina A Brasil, Ba

Role: primary

+5571987929440

Patricia V Lordelo, Phd

Role: backup

+5571988592400

Other Identifiers

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U1111-1162-0945

Identifier Type: -

Identifier Source: org_study_id

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