NCT05118607

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

The Use of Microcurrent and Low Current Bioelectrical Stimulation in the Treatment of Post-prostatectomy Erectile Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Federal University of Health Science of Porto Alegre · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction Following Radical Prostatectomy

Interventions

Type	Name	Description
DEVICE	IG1	application of low intensity transcutaneous penile electrical stimulation for 45 minutes using frequency.

Timeline

• Start date: 2018-01-15
• Primary completion: 2018-05-02
• Completion: 2019-07-15
• First posted: 2021-11-12
• Last updated: 2021-11-12

Locations

1 site across 1 country: Brazil