Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy

Not Applicable

Recruiting

• Conditions: Urinary Incontinence; Post Prostatectomy

• Registration Number: NCT03048799
• Lead Sponsor: Centro de Atenção ao Assoalho Pélvico

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.

Study Timeline

• Study Start: 2016-12-05
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Primary Completion: 2020-06-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-23
• Study Completion: 2024-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pad Test (grams)	1 month	The pad test aims to quantify the urinary loss in different physical activities in the period of 1 hour.

Secondary Outcome Measures

Name	Time	Method
quality of life specified urinary incontinence	6 month	The ICIQ-SF is a self-administered questionnaire composed of four questions that assess the frequency, severity and impact of UI, as well as a set of eight self-diagnosis items related to the causes or UI situations experienced by the respondents. The final score is found from the sum of the score of questions 3, 4 and 5. The overall score ranges from 0 to 21 points and the higher the score the greater the impact on the quality of life. The impact on the quality of life is divided in such a way: no impact (0 point); Light impact (from 1 to 3 points); Moderate impact (from 4 to 6 points); Serious impact (from 7 to 9 points); And very serious impact (10 or more points
Quality of life Scale Questionaire	1 year after	Scale questionaire
Pad Test (grams)	6 month after	The pad test aims to quantify the urinary loss in different physical activities in the period of 1 hour.
Erectile dysfunction	6 month	A questionnaire with 15 questions will be applied in which it evaluates the erectile dysfunction, the name of questionnaire is International Index of Erectile Dysfunction (IIEF-5)

Trial Locations

Locations (1)

Centro de Atenção ao assoalho pélvico; 🇧🇷 Salvador, Bahia, Brazil