Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy

NCT ID: NCT03048799

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-05
• Study Completion Date: 2024-12-05

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.

Conditions

Urinary Incontinence; Post Prostatectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Radiofrequency on and Kinesiotherapy

The radiofrequency application protocol with CAPENERGY device, which has two electrodes: an active one, which will be introduced into the anal region, using a condom and gel to The emission of radiofrequency and another electrode, dispersive, coupled to the patient's hip, which will function as earth. The temperature used in the treatment will be 41 ° C, which this parameter will be placed in the equipment, maintained for 2 minutes. Five RF sessions will be performed, with a seven-day interval between them. For the application, participants will be placed in lateral decubitus position. The session will be quick, with an average duration of 20 minutes.Kinesiotherapy will be done once a week, totaling five sessions. Initially, verbal information about location, function, and the correct way to contract the pelvic floor (PA) will be given.

Group Type: ACTIVE_COMPARATOR

Radiofrequency

Intervention Type: DEVICE

The radiofrequency application protocol will be used in the form of capacitive electrical transfer, bipolar configuration, with CAPENERGY device (Figure 1), which has two electrodes: an active one, which will be introduced into the anal region, using a condom and gel to The emission of radiofrequency and another electrode, dispersive, coupled to the patient's hip, which will function as earth. The active electrode has at its end a sensor capable of capturing the temperature. The temperature used in the treatment will be 41 ° C, which this parameter will be placed in the equipment. Upon reaching the desired heating, the apparatus maintains the temperature and thus the application of the radiofrequency will be maintained for 2 minutes.

Radiofrequency off and Kinesiotherapy

The patient will be in lateral decubitus, the anal probe of the radiofrequency apparatus will be introduced, with the gel previously heated. The radio frequency will be off.

Kinesiotherapy will be done once a week, totaling five sessions. Initially, verbal information about location, function, and the correct way to contract the pelvic floor (PA) will be given. In addition, at this point will be advised on the performance of "The Knack", which is a pre-contraction of the PA during the performance of some abdominal effort such as coughing, sneezing or laughing.

Group Type: PLACEBO_COMPARATOR

Radiofrequency

Intervention Type: DEVICE

The radiofrequency application protocol will be used in the form of capacitive electrical transfer, bipolar configuration, with CAPENERGY device (Figure 1), which has two electrodes: an active one, which will be introduced into the anal region, using a condom and gel to The emission of radiofrequency and another electrode, dispersive, coupled to the patient's hip, which will function as earth. The active electrode has at its end a sensor capable of capturing the temperature. The temperature used in the treatment will be 41 ° C, which this parameter will be placed in the equipment. Upon reaching the desired heating, the apparatus maintains the temperature and thus the application of the radiofrequency will be maintained for 2 minutes.

Interventions

Radiofrequency

The radiofrequency application protocol will be used in the form of capacitive electrical transfer, bipolar configuration, with CAPENERGY device (Figure 1), which has two electrodes: an active one, which will be introduced into the anal region, using a condom and gel to The emission of radiofrequency and another electrode, dispersive, coupled to the patient's hip, which will function as earth. The active electrode has at its end a sensor capable of capturing the temperature. The temperature used in the treatment will be 41 ° C, which this parameter will be placed in the equipment. Upon reaching the desired heating, the apparatus maintains the temperature and thus the application of the radiofrequency will be maintained for 2 minutes.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centro de Atenção ao Assoalho Pélvico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro de Atenção ao assoalho pélvico

Salvador, Estado de Bahia, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Patricia Lordelo, post doc

Role: CONTACT

pvslordelo@hotmail.com

+5571988592400

Facility Contacts

Patricia Lordelo, post doc

Role: primary

pvslordelo@hotmail.com

+5571988592400

Other Identifiers

U1111-1192-4467

Identifier Type: -

Identifier Source: org_study_id