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Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy

Primary Purpose

Urinary Incontinence, Post Prostatectomy

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Radiofrequency
Sponsored by
Centro de Atenção ao Assoalho Pélvico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Atenção ao assoalho pélvicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Radiofrequency on and Kinesiotherapy

Radiofrequency off and Kinesiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pad Test (grams)
The pad test aims to quantify the urinary loss in different physical activities in the period of 1 hour.
Quality of life Scale Questionaire
Scale questionaire
Quality of life Scale Questionaire
Scale questionaire
Quality of life Scale Questionaire
Scale questionaire
Erectile dysfunction
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)
Erectile dysfunction
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)
quality of life specified urinary incontinence
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 specified urinary incontinence
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

Full Information

First Posted
February 2, 2017
Last Updated
June 21, 2023
Sponsor
Centro de Atenção ao Assoalho Pélvico
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1. Study Identification

Unique Protocol Identification Number
NCT03048799
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Atenção ao Assoalho Pélvico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Post Prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency on and Kinesiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Radiofrequency off and Kinesiotherapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Radiofrequency
Intervention Description
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 Measure Information:
Title
Pad Test (grams)
Description
The pad test aims to quantify the urinary loss in different physical activities in the period of 1 hour.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Pad Test (grams)
Description
The pad test aims to quantify the urinary loss in different physical activities in the period of 1 hour.
Time Frame
6 month after
Title
Quality of life Scale Questionaire
Description
Scale questionaire
Time Frame
1 month after
Title
Quality of life Scale Questionaire
Description
Scale questionaire
Time Frame
6 month after
Title
Quality of life Scale Questionaire
Description
Scale questionaire
Time Frame
1 year after
Title
Erectile dysfunction
Description
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)
Time Frame
1 month
Title
Erectile dysfunction
Description
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)
Time Frame
6 month
Title
quality of life specified urinary incontinence
Description
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
Time Frame
1 month
Title
quality of life specified urinary incontinence
Description
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
Time Frame
6 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Lordelo, post doc
Phone
+5571988592400
Email
pvslordelo@hotmail.com
Facility Information:
Facility Name
Centro de Atenção ao assoalho pélvico
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40290000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Lordelo, post doc
Phone
+5571988592400
Email
pvslordelo@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radiofrequency in the Treatment of Urinary Incontinence After Radical Prostatectomy

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