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Radiofrequency in the Female Stress Urinary Incontinence

Radiofrequency in the Female Stress Urinary Incontinence: A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02617797
Enrollment
42
Registered
2015-12-01
Start date
2015-09-30
Completion date
2025-06-30
Last updated
2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Stress Incontinence

Keywords

Urinary Stress Incontinence, Radiofrequency, Women

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)

Interventions

DEVICERadiofrequency

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

DEVICERadiofrequency OFF

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

Sponsors

Centro de Atenção ao Assoalho Pélvico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urinary loss modificationone week, one month, two month , three month and six monthThe 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.

Secondary

MeasureTime frameDescription
specific Quality of lifeone weekThe quality of life will be assessed by one for specific urinary symptoms - Health King , measure with unit of the scale
Sexual Functionone weekWill be evaluated before and after radio frequency sexual function of women, through questionary 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 lifeone weekWill be evaluated before and after radio frequency the overall quality of life - SF-36 - questionaire.

Countries

Brazil

Contacts

Primary ContactPatricia V Lordelo, Phd
pvslordelo@hotmail.com+5571988592400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026