Vacuum Therapy for the Treatment of Penile Numbness/Sensory Changes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vacuum erection device.
- Who it may be relevant to
- Registry conditions: Penile Numbness. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device 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 foll
Primary outcome measures
- Feasibility of recruitment to study [Time frame: 6 months]
- Acceptability of treatment [Time frame: 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Canada · 1 center
- The Ottawa Hospital — Ottawa
Identifiers
NCT: NCT07171567 · 20250231-01H