Clinical trial NCT03048799: Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy
Official title: Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Post Prostatectomy
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-prostatectomy urinary incontinence (IUPP) is a difficult to treat complication that causes a profound negative impact on the individual's quality of life, as well as seriously disrupts the physician-patient relationship and is a substantial public health problem . Urinary incontinence (UI) can occur both in the treatment of benign prostatic hyperplasia (BPH) and in the treatment of prostate cancer.

In the treatment of benign disease, this complication is associated with a very low prevalence, initially of 9% and about 1% in 12 months postoperatively. In radical prostatectomy, the prevalence is higher, varying from 2% to 87%, depending on the populations and sites studied, the definitions used, the different methodologies employed in the evaluation of incontinence, and also the different degrees of intensity of the disease . Several authors have evaluated the incidence of incontinence after robotic radical prostatectomy, open and laparoscopically. With these techniques, the reported total UI incidence varies from 4% to 40% .

With the high prevalence of IUPP, accelerating the recovery of urinary control is an important priority for patients and their caregivers, and the search for effective and low-risk treatments is a constant. Thus, the possibility of treatment with the radiofrequency (RF) feature arises.

Detailed description: A current treatment proposal is the use of radiofrequency, which is a diathermic process generated by the radiation of an electromagnetic spectrum, resulting in an immediate retraction of existing collagen and subsequent activation of fibroblasts causing a neocollagenesis. In studies using radiofrequency to treat SUI, a therapeutic response to 50% was shown. Representing a more cost-effective treatment than surgery.

Eligibility 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.

Primary outcomes:
measure: Pad Test (grams)
timeFrame: 1 month
Secondary outcomes:
measure: Pad Test (grams)
timeFrame: 6 month after
measure: Quality of life Scale Questionaire
timeFrame: 1 month after
measure: Quality of life Scale Questionaire
timeFrame: 6 month after
measure: Quality of life Scale Questionaire
timeFrame: 1 year after
measure: Erectile dysfunction
timeFrame: 1 month
measure: Erectile dysfunction
timeFrame: 6 month
measure: quality of life specified urinary incontinence
timeFrame: 1 month
measure: quality of life specified urinary incontinence
timeFrame: 6 month
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Centro de Atenção ao assoalho pélvico
state: Bahia
Study officials:
References: