Vacuum Therapy for Erectile Dysfunction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new approach to help men with numbness or insensitivity in their penis. Participants will use a vacuum erection device (VED) daily for six months. The main goal is to determine if using the VED is feasible and acceptable for these men. Suitable candidates for this trial are adult men who have already consulted a urologist about their penile numbness. The study will monitor the frequency of device use and any improvement in symptoms over time. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the chance to be among the first to explore this innovative approach.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this vacuum erection device is safe for use in men with penile insensitivity?
Research has shown that vacuum erection devices (VEDs) are generally safe for most men. Studies have found that using a VED for short daily sessions, along with certain medications, effectively improves erectile function. Reports indicate that these devices pose less risk compared to some other treatments for erectile dysfunction. One study highlighted that VED therapy is promising for various sexual issues and has a strong safety record. This suggests that VEDs are well-tolerated, with few side effects reported.12345
Why are researchers excited about this trial?
The vacuum erection device (VED) is unique because it offers a non-invasive, drug-free approach to treating erectile dysfunction. Unlike oral medications like Viagra or Cialis, which rely on chemical interactions to improve blood flow, the VED works by creating a vacuum around the penis, drawing blood into the area to facilitate an erection. This mechanical method can be especially beneficial for individuals who cannot take oral medications due to side effects or medical conditions. Researchers are excited about VED because it provides an alternative solution that is both simple to use and avoids the systemic side effects associated with drug treatments.
What evidence suggests that this vacuum erection device is effective for erectile dysfunction?
Research shows that vacuum erection devices (VEDs), which participants in this trial will use, effectively treat erectile dysfunction. Studies have found that 69% to 93% of users achieve erections suitable for sex, even those with challenging conditions like diabetes or spinal cord injuries. One study found that using VEDs for penile rehabilitation improved natural erections in 60% of cases. Satisfaction rates for both users and their partners are also high, often exceeding 80%. These findings suggest that VEDs could be a promising option for enhancing penile sensitivity and function.12467
Who Is on the Research Team?
Luke Witherspoon
Principal Investigator
The Ottawa Hospital Research Institute
Are You a Good Fit for This Trial?
This trial is for adult males experiencing penile numbness or sensory changes, who can visit the Ottawa Hospital's Men's Health Clinic. Participants must be willing to use a vacuum erection device daily and complete regular questionnaires.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use a Health Canada Class I VED daily over a six-month period with biweekly check-ins and monthly questionnaire assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vacuum Erection Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor