Recruiting
Early Phase 1

VED

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT07171567

Conditions

Penile Numbness

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vacuum erection device

Study Details

Brief summary:

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.

Conditions

Penile Numbness

Study ID

NCT07171567

Start date

Oct 1, 2025

Status verified date

Sep, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: vacuum erection device (VED)

Interventions

Vacuum erection device

A vacuum erection device (VED) is a mechanical device designed to enhance blood flow to the corpora cavernosa by creating a vacuum environment. When combined with a constriction ring at the base of the penis, VEDs can promote and sustain an erection.

This is a prospective, uncontrolled, hypothesis-generating pilot study. Eight adult male participants with penile insensitivity will be enrolled and asked to use a VED daily for six months. Monthly self-reported questionnaire data and biweekly follow-up calls will be used to assess feasibility and to collect exploratory outcome data.

Primary outcome measure

  • Feasibility of recruitment to study [ Time Frame: 6 months ]
  • Acceptability of treatment [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1Y4E9

Contacts

Principal Investigator:

Luke Witherspoon, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Keywords

  • Penile numbness
  • Penile sensation changes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-09-12.