Radiofrequency in the Female Stress Urinary Incontinence
Study Details
Study Description
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 Continene 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 cinesioteraphy ( clinical and in home) and the group control utilize turn off- radiofrequency and cinesiotherapy(clinical and in home). The protocol f the cinesiotherapu is the same both the group, and the protocol radiofrequency the group experimental will 5 sessions (one per week) with temperature 38ºC during 2 minuts. 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)
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Radiofrequency Experimental group: women with urinary incontinence are subjected to standard treatment cinesiotherapy 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: Radiofrequecy
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
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Sham Comparator: Radiofrenquency Off Control group: women with stress urinary incontinence will be submitted to the treatment of cinesioterapia 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.
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Outcome Measures
Primary Outcome Measures
- Urinary loss modification [one week, one month, two month , theree month and six month]
The pad test will be held at the beginning of treatment and one week, one month , two month , theree month and six month after the last session of radio frequency. The pad test it quantifies in grams urinary loss through the absorbent weighing.
Secondary Outcome Measures
- specific Quality of life [one week]
The quality of life will be assessed by one for especific urinary symptoms - Health King , measuare with unit of the scale
- Sexual Function [one week]
Will be evaluated before and after radio frequency sexual function of women, through quetionario 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.
- overall quality of life [one week]
Will be evaluated before and after radio frequency the overall quality of life - SF-36 - questionaire.
Eligibility Criteria
Criteria
Inclusion Criteria:
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21 Women with age between 18-59 years old,
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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:
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Patients with cognitive deficits or psychiatric illness;
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suffering from chronic degenerative neurological diseases; which have greater than 50 ml post-voiding residue ;
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sensory deficit in the genital region;
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people with pacemakers and implantable cardioverter-defibrillator and pregnant women will be excluded from the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Centro de Atenção ao Assoalho Pelvico | Salvador | Ba | Brazil | 40.290-000 |
Sponsors and Collaborators
- Centro de Atenção ao Assoalho Pélvico
Investigators
- Principal Investigator: Patricia Lordelo, PhD, Centro de Atenção ao Assoalho Pélvico - BAHIANA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- U1111-1162-0945