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Trial record 31 of 1293 for:    physician patient AND (relations OR communication) | Recruiting, Not yet recruiting, Available Studies

Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT03048799
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence Post Prostatectomy Device: Radiofrequency Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy: Randomized Clinical Trial
Actual Study Start Date : December 5, 2016
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : December 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: 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.

Placebo Comparator: 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.

Device: 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.




Primary Outcome Measures :
  1. Pad Test (grams) [ Time Frame: 1 month ]
    The pad test aims to quantify the urinary loss in different physical activities in the period of 1 hour.


Secondary Outcome Measures :
  1. Pad Test (grams) [ Time Frame: 6 month after ]
    The pad test aims to quantify the urinary loss in different physical activities in the period of 1 hour.

  2. Quality of life [ Time Frame: 1 month after ]
    Scale questionnaire

  3. Quality of life [ Time Frame: 6 month after ]
    Scale questionnaire

  4. Quality of life [ Time Frame: 1 year after ]
    Scale questionnaire

  5. Erectile dysfunction [ Time Frame: 1 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)

  6. Erectile dysfunction [ Time Frame: 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)

  7. quality of life specified urinary incontinence [ Time Frame: 1 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

  8. quality of life specified urinary incontinence [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048799


Contacts
Contact: Patricia Lordelo, post doc +5571988592400 pvslordelo@hotmail.com

Locations
Brazil
Centro de Atenção ao assoalho pélvico Recruiting
Salvador, Bahia, Brazil, 40290000
Contact: Patricia Lordelo, post doc    +5571988592400    pvslordelo@hotmail.com   
Sponsors and Collaborators
Centro de Atenção ao Assoalho Pélvico

Responsible Party: Centro de Atenção ao Assoalho Pélvico
ClinicalTrials.gov Identifier: NCT03048799     History of Changes
Other Study ID Numbers: U1111-1192-4467
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders