Using radiofrequency to treat urinary incontinence after prostate surgery
Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy: Randomized Clinical Trial
This study is testing a new radiofrequency treatment to see if it can help men aged 18 to 65 who have urinary incontinence after prostate surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Male |
| Sponsor | Centro de Atenção ao Assoalho Pélvico Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Salvador, Bahia) |
| Trial ID | NCT03048799 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of radiofrequency treatment for urinary incontinence that occurs after radical prostatectomy. The approach utilizes a diathermic process that generates electromagnetic radiation to promote collagen retraction and activate fibroblasts, leading to neocollagenesis. The goal is to provide a less invasive and more cost-effective alternative to surgical options for managing this common complication. Participants will be men aged 18 to 65 who experience urinary incontinence following prostate surgery and consent to participate.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 65 who have urinary incontinence following radical prostatectomy and are willing to participate in the study.
Not a fit: Patients who are less than 45 days postoperative, have neurological degenerative diseases, or have certain medical implants will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from urinary incontinence after prostate surgery.
How similar studies have performed: Previous studies using radiofrequency for similar conditions have shown a therapeutic response rate of around 50%, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * will be individuals from 18 to 65 years of age with clinical complaints of urinary incontinence after prostatectomy and who agree to voluntarily participate in the research. Exclusion Criteria: * Will be excluded from the study the patients with time less than 45 days postoperative, difficulty understanding the proposed instruments, patients with neurological degenerative chronic diseases, patients with implantable cardioverter defibrillators and carriers of iatrogenic metals in the pelvic region.
Where this trial is running
Salvador, Bahia
- Centro de Atenção ao assoalho pélvico — Salvador, Bahia, Brazil (Recruiting)
Study contacts
- Study coordinator: Patricia Lordelo, post doc
- 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.