Using radiofrequency to treat urinary stress incontinence in women
Radiofrequency in the Female Stress Urinary Incontinence: A Randomized Clinical Trial
This study is testing if a new non-invasive radiofrequency treatment can help women with urinary stress incontinence feel better by improving their pelvic floor muscle function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | Female |
| Sponsor | Centro de Atenção ao Assoalho Pélvico Academic / other |
| Locations | 1 site (Salvador, Ba) |
| Trial ID | NCT02617797 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of non-invasive radiofrequency treatment to stimulate collagen production in women suffering from urinary stress incontinence (SUI). Participants will be randomly assigned to either an experimental group receiving radiofrequency treatment combined with kinesiotherapy or a control group receiving kinesiotherapy alone. The study aims to assess the effectiveness of this approach in improving pelvic floor muscle function and alleviating symptoms of SUI. The trial will include women aged 18-59 with a specific diagnosis of urinary incontinence and adequate pelvic floor muscle contractility.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-59 diagnosed with urinary stress incontinence and demonstrating adequate pelvic floor muscle contractility.
Not a fit: Patients with cognitive deficits, chronic neurological diseases, or those with certain medical devices like pacemakers will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for women suffering from urinary stress incontinence, potentially improving their quality of life.
How similar studies have performed: While the use of radiofrequency for treating urinary incontinence is gaining interest, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Salvador, Ba
- Centro de Atenção ao Assoalho Pelvico — Salvador, Ba, Brazil (Recruiting)
Study contacts
- Principal investigator: Patricia Lordelo, PhD — Centro de Atenção ao Assoalho Pélvico - BAHIANA
- Study coordinator: Patricia V Lordelo, Phd
- Email: pvslordelo@hotmail.com
- Phone: +5571988592400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.