Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy

NCT03048799 | Unknown DMC

• 1 other identifier: U1111-1192-4467
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Post Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Pad Test (grams)

  The pad test aims to quantify the urinary loss in different physical activities in the period of 1 hour.

  1 month

Secondary Outcomes (8)

• Pad Test (grams)

  6 month after

• Quality of life Scale Questionaire

  1 month after

• Quality of life Scale Questionaire

  6 month after

• Quality of life Scale Questionaire

  1 year after

• Erectile dysfunction

  1 month

Study Arms (2)

Radiofrequency on and Kinesiotherapy

ACTIVE COMPARATOR

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.

Device: Radiofrequency

Radiofrequency off and Kinesiotherapy

PLACEBO COMPARATOR

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.

Device: Radiofrequency

Interventions

Radiofrequency 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; Radiofrequency on and Kinesiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead

Study Sites (1)

Centro de Atenção ao assoalho pélvico

Salvador, Estado de Bahia, 40290000, Brazil

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patricia Lordelo, post doc

CONTACT

+5571988592400; pvslordelo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 9, 2017
• Study Start: December 5, 2016
• Primary Completion: June 30, 2020
• Study Completion: December 5, 2024
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)