Penile Numbness
Conditions
Keywords
Penile numbness, Penile sensation changes
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.
Interventions
DEVICEVacuum 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.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed