Vacuum Therapy for the Treatment of Penile Numbness/Sensory Changes

Not Applicable

Recruiting

• Conditions: Penile Numbness

• Registration Number: NCT07171567
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-26
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2025-10-01
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment to study	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
Acceptability of treatment	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

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada