Radiofrequency in the Female Stress Urinary Incontinence

Urinary Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02617797
• Other study ID #: U1111-1162-0945
• Status: Recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 2025

Study information

• Verified date: June 2023
• Source: Centro de Atenção ao Assoalho Pélvico
• Contact: Patricia V Lordelo, Phd
• Phone: +5571988592400
• Email: pvslordelo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Device:
• Radiofrequency
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 OFF
Will be used to put off radio frequency will be heated glycerin to occur masking for the patient.

Locations

Country	Name	City	State
Brazil	Centro de Atenção ao Assoalho Pelvico	Salvador	Ba

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Atenção ao Assoalho Pélvico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	specific Quality of life	The quality of life will be assessed by one for specific urinary symptoms - Health King , measure with unit of the scale	one week
Secondary	Sexual Function	Will 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.	one week
Secondary	overall quality of life	Will be evaluated before and after radio frequency the overall quality of life - SF-36 - questionaire.	one week