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

NCT ID: NCT05118607

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-07-15

Brief Summary

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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

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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.

Conditions

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Erectile Dysfunction Following Radical Prostatectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention (IG1)

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

Group Type OTHER

IG1

Intervention Type DEVICE

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

Interventions

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IG1

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Cristiane Carboni

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristiane Carboni

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Mundo do Assoalho Pélvico

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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02718918.1.0000.5221

Identifier Type: -

Identifier Source: org_study_id