Daily vacuum device therapy for penile numbness and sensation changes
Vacuum Therapy for the Treatment of Penile Numbness/Sensory Changes
EARLY_PHASE1 · Ottawa Hospital Research Institute · NCT07171567
This will try daily use of a Health Canada–approved vacuum erection device for six months in adult men with penile numbness to see if people can use it regularly and whether symptoms change.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Ottawa Hospital Research Institute (other) |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT07171567 on ClinicalTrials.gov |
What this trial studies
This is a prospective, uncontrolled, hypothesis-generating pilot enrolling eight adult men with penile numbness seen at the Ottawa Hospital Men's Health Clinic. Participants will use a Health Canada Class I vacuum erection device daily for six months with biweekly check-ins and monthly questionnaires delivered via LimeSurvey, including the IIEF-5 and two custom penile sensitivity instruments. The primary aim is to examine feasibility and acceptability using adherence and completion metrics; symptom changes will be explored with within-subject comparisons (e.g., Wilcoxon signed-rank test). Results are descriptive and intended to inform the design of larger, controlled studies.
Who should consider this trial
Good fit: Adult men (age 18 and over) who have been evaluated by a urologist for penile numbness/insensitivity and are willing to use a vacuum erection device daily for six months are ideal candidates.
Not a fit: Men under 18, those who have not been seen by a urologist for their symptoms, or individuals whose numbness is due to conditions unlikely to respond to mechanical stimulation may not receive benefit.
Why it matters
Potential benefit: If successful, this could offer a simple, non-invasive option to improve or manage penile sensation in affected men.
How similar studies have performed: Vacuum erection devices are established for erectile dysfunction but using daily VED therapy specifically to address penile numbness is largely novel with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Male adults (age 18 and over) * Have been seen by a urologist in consultation for penile numbness/insensitivity 5.2 Exclusion Criteria \- Under 18 years of age
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Luke Witherspoon — Ottawa Hospital Research Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Penile Numbness, Penile numbness, Penile sensation changes