Last reviewed · How we verify
NCT07171567
Vacuum Therapy for the Treatment of Penile Numbness/Sensory Changes
EARLY_PHASE1 trial testing Vacuum erection device in Penile Numbness in 8 participants. Currently enrolling.
1 October 2027
Quick facts
| Lead sponsor | Ottawa Hospital Research Institute |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 8 |
| Start date | 1 October 2025 |
| Primary completion | 1 October 2027 |
| Estimated completion | 1 October 2027 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Vacuum erection device
Conditions studied
- Penile Numbness — all drugs for Penile Numbness →
Sponsor
Ottawa Hospital Research Institute
Who can join
18 and older, male only, with Penile Numbness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, uncontrolled, Hypothesis generating study. A total of eight adult male participants experiencing penile insensitivity will be recruited through the Ottawa Hospital's Men's Health Clinic. Participants will receive a Health Canada Class I VED to use daily over a six-month period. The study includes biweekly check-ins and monthly questionnaire assessments (including the IIEF-5 and two custom instruments focused on penile sensitivity) administered via Lime Survey. The primary outcome is to explore the feasibility and acceptability of daily vacuum erection device (VED) therapy over a 6-month period in adult males experiencing penile numbness/insensitivity. Data analysis will focus on feasibility metrics (e.g., adherence rates, completion of assessments) and descriptive statistics. Any changes in questionnaire scores over time will be evaluated using within-subject comparisons (e.g., Wilcoxon signed-rank test), recognizing that findings are preliminary and not generalizable due to the lack of a control group.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07171567
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Ottawa Hospital Research Institute trials
Trials by the same sponsor.
- NCT07464080 — Advanced Brain Imaging-TKA (fMRI-TKA) · NA · recruiting
- NCT07058025 — Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants · Phase 2 · not yet recruiting
- NCT07177833 — Title Fractioned CO2 Laser in the Treatment of Chronic Phase Peyronie's Disease · Phase 1 · recruiting
- NCT06929767 — Do Blood Tests Help to Decide Which Patients With Flares of Chronic Obstructive Pulmonary Disease (COPD) Need Antibiotic · Phase 4 · not yet recruiting
- NCT07051889 — Lower Trapezius Tendon Transfer vs Partial Cuff Repair in Massive Rotator Cuff Tears · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07171567 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ottawa Hospital Research Institute
- Last refreshed: 12 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07171567.