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

NCT05118607 | Completed

• 1 other identifier: 02718918.1.0000.5221
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

Intervention (IG1)

OTHER

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

Device: IG1

Interventions

IG1 DEVICE

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

Intervention (IG1)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: erectile dysfunction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Mundo do Assoalho Pélvico

Porto Alegre, Rio Grande do Sul, 90540040, Brazil

Location

Study Officials

• Cristiane Carboni

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 12, 2021
• Study Start: January 15, 2018
• Primary Completion: May 2, 2018
• Study Completion: July 15, 2019
• Last Updated: November 12, 2021

Record last verified: 2021-11

Locations

BR (1)