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Recruiting

NCT Number: NCT07171567

Vacuum Therapy for the Treatment of Penile Numbness/Sensory Changes

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.

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Key information

Conditions

Penile Numbness

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1Y4E9, Canada

Location status: Recruiting

Location contact

Amanda Ross

CONTACT

[email protected]

6137985555

Luke Witherspoon, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vacuum erection device

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 outcomes

  1. Feasibility of recruitment to study

    Time frame: 6 months

    To evaluate the feasibility of recruitment to a study examining the daily use of vacuum erection device (VED) therapy over a 6-month period in adult males with penile numbness or reduced sensation. Feasibility will be assessed via the ability to enroll subjects within a 1 year period and by treatment adherence and completion rates. Treatment adherence/completion will be assessed during standardized study visits

  2. Acceptability of treatment

    Time frame: 6 months

    Acceptability will be evaluated through patient-reported experiences using online questionnaires. Changes in penile sensation will be measured using patient-reported outcomes of erectile function (standardized questionnaires) and a subjective Likert scale of penile numbness collected at baseline, throughout the study and at the end of the 6-month intervention

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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