Radiofrequency in the Female Stress Urinary Incontinence

NCT02617797 | Unknown

• 1 other identifier: U1111-1162-0945
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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)

Conditions

Urinary Stress Incontinence

Keywords

Urinary Stress Incontinence; Radiofrequency; Women

Outcome Measures

Primary Outcomes (1)

• 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.

  one week, one month, two month , three month and six month

Secondary Outcomes (3)

• specific Quality of life

  one week

• Sexual Function

  one week

• overall quality of life

  one week

Study Arms (2)

Radiofrequency

EXPERIMENTAL

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

Radiofrequency Off

SHAM COMPARATOR

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

Interventions

Radiofrequency 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

Radiofrequency OFF DEVICE

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

Radiofrequency Off

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead

Study Sites (1)

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, 40.290-000, Brazil

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Lordelo, PhD

  Centro de Atenção ao Assoalho Pélvico - BAHIANA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia V Lordelo, Phd

CONTACT

+5571988592400; pvslordelo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: December 1, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

BR (1)