Clinical trial NCT02617797: Radiofrequency in the Female Stress Urinary Incontinence
Official title: Radiofrequency in the Female Stress Urinary Incontinence: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Stress Incontinence
Keywords: Urinary Stress Incontinence
Radiofrequency
Women
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Urinary loss modification
timeFrame: one week, one month, two month , three month and six month
Secondary outcomes:
measure: specific Quality of life
timeFrame: one week
measure: Sexual Function
timeFrame: one week
measure: overall quality of life
timeFrame: one week
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Centro de Atenção ao Assoalho Pelvico
state: Ba
Study officials:
affiliation: Centro de Atenção ao Assoalho Pélvico - BAHIANA
name: Patricia Lordelo, PhD
role: PRINCIPAL_INVESTIGATOR
References: