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The Use of Bioelectrical Stimulation in the Treatment of Post-prostatectomy Erectile Dysfunction

Primary Purpose

Erectile Dysfunction Following Radical Prostatectomy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
IG1
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction Following Radical Prostatectomy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male patient, aged 40 to 75 years, with a stable marital relationship (6 months) Diagnosis of post-prostatectomy erectile dysfunction (IIEF5 score less than 22)

Exclusion Criteria:

Neurogenic ED (spinal injury, Parkinson, MS) Hypogonadism (total testosterone < 300 ng/dl) Decompensated diabetes mellitus (Fasting Glucose>200 and/or Glycated Hemoglobin>8%) Decompensated systemic arterial hypertension (SBP > 160 and/or DBP >100 Morbid obesity Use of vacuum device smokers Diagnosis of coronary artery disease and/or cerebrovascular disease Impossibility of understanding the objectives, study technique and informed consent cognitive deficit

Sites / Locations

  • Mundo do Assoalho Pélvico

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention (IG1)

Arm Description

application of low intensity transcutaneous penile electrical stimulation for 45 minutes using frequency

Outcomes

Primary Outcome Measures

The present study aims to evaluate the effect of BES on post-prostatectomy ED using the International Index of Erectile Function-5 (IIEF-5) questionnaire and the Erection hardness Score (EHS) questionnaire.
The present study aims to evaluate the effect of BES on post-prostatectomy ED using the International Index of Erectile Function-5 (IIEF-5) questionnaire and the Erection hardness Score (EHS) questionnaire.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2021
Last Updated
November 2, 2021
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT05118607
Brief Title
The Use of Bioelectrical Stimulation in the Treatment of Post-prostatectomy Erectile Dysfunction
Official Title
The Use of Microcurrent and Low Current Bioelectrical Stimulation in the Treatment of Post-prostatectomy Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

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

5. Study Description

Brief Summary
Erectile dysfunction (ED) affects up to 20% of men and is a growing problem with advancing age. There are many causes that contribute to ED, including the concomitant use of prescription drugs for health problems, including hypertension, or diseases such as diabetes. causes an up-regulation or increased local tissue expression of these proteins. This study follows the demonstration of the effectiveness of using BES in the treatment of ED. The aim of this study will be to examine the potentially additive effect of adding a third arm to the previous protocol to include the addition of 4 new target proteins to VEGF, including endothelial nitric oxide (eNOS), stromal-derived factor 1 (SDF-1), insulin-like growth factor (IGF) and follistatin.
Detailed Description
For this randomized clinical trial, 10 patients from a private Urology clinic will be selected. Each patient will serve as their own two-month documentation control using the validated IIEF-5 and EHS questionnaires. The intervention period will last 8 weeks. And 6 months of follow-up after the end of treatment to see how long the benefit lasts without continued treatment. The assessment will be carried out before the intervention period (pre-intervention) and after the intervention period (post-intervention and follow-up) for all participants. All patients who, after medical consultation, are diagnosed with erectile dysfunction and who meet the inclusion criteria will be included in the study. Erectile function will be assessed using the validated questionnaire IIEF-5. The instrument will be completed by a blind researcher and the technique will be applied by a physiotherapist trained in the area. Erectile dysfunction (ED) was defined as the inability to achieve and/or maintain sufficient penile erection for satisfactory sexual performance 11 for at least 6 months, accompanied by an IIEF5 questionnaire score of less than 22 points. The patients were in the supine position, in a lithotomy position. They will undergo trichotomy at the site of placement of the self-adhesive surface electrodes. Each patient will have their own pair of electrodes that will be used until the end of therapy, and they will be discarded after the end of the sessions. The intervention will consist of the application of low intensity transcutaneous penile electrical stimulation for 45 minutes using frequency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction Following Radical Prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention (IG1)
Arm Type
Other
Arm Description
application of low intensity transcutaneous penile electrical stimulation for 45 minutes using frequency
Intervention Type
Device
Intervention Name(s)
IG1
Intervention Description
application of low intensity transcutaneous penile electrical stimulation for 45 minutes using frequency.
Primary Outcome Measure Information:
Title
The present study aims to evaluate the effect of BES on post-prostatectomy ED using the International Index of Erectile Function-5 (IIEF-5) questionnaire and the Erection hardness Score (EHS) questionnaire.
Description
The present study aims to evaluate the effect of BES on post-prostatectomy ED using the International Index of Erectile Function-5 (IIEF-5) questionnaire and the Erection hardness Score (EHS) questionnaire.
Time Frame
1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
erectile dysfunction
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patient, aged 40 to 75 years, with a stable marital relationship (6 months) Diagnosis of post-prostatectomy erectile dysfunction (IIEF5 score less than 22) Exclusion Criteria: Neurogenic ED (spinal injury, Parkinson, MS) Hypogonadism (total testosterone < 300 ng/dl) Decompensated diabetes mellitus (Fasting Glucose>200 and/or Glycated Hemoglobin>8%) Decompensated systemic arterial hypertension (SBP > 160 and/or DBP >100 Morbid obesity Use of vacuum device smokers Diagnosis of coronary artery disease and/or cerebrovascular disease Impossibility of understanding the objectives, study technique and informed consent cognitive deficit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiane Carboni
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mundo do Assoalho Pélvico
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90540040
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Use of Bioelectrical Stimulation in the Treatment of Post-prostatectomy Erectile Dysfunction

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