Radiofrequency in the Female Stress Urinary Incontinence

Centro de Atenção ao Assoalho Pélvico

Status: Enrolling

Conditions: Urinary Stress Incontinence

Treatments: Device: Radiofrequency; Device: Radiofrequency OFF

Study type: Interventional

Funder types: Other

Identifiers

NCT02617797

U1111-1162-0945

Details and patient eligibility

About

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)

Enrollment: 42 estimated patients

Sex: Female

Ages: 18 to 59 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

42 participants in 2 patient groups

Radiofrequency

Experimental group

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.

Treatment:

Device: Radiofrequency

Radiofrequency Off

Sham Comparator group

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.

Treatment:

Device: Radiofrequency OFF