Vacuum Therapy for the Treatment of Penile Numbness/Sensory Changes

Ottawa Hospital Research Institute

Status and phase: Enrolling; Early Phase 1

Conditions: Penile Numbness

Treatments: Device: Vacuum erection device

Study type: Interventional

Funder types: Other

Identifiers

NCT07171567

20250231-01H

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

vacuum erection device (VED)

Experimental group

Treatment:

Device: Vacuum erection device