Testing how well men can operate their penile implant pump
Evaluation of Penile Prosthesis Pump Manipulation
This test will see if men with penile implants can operate the pump properly and whether that ability is linked to erection firmness and sexual satisfaction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Pierre-Bénite) |
| Trial ID | NCT06376513 on ClinicalTrials.gov |
What this trial studies
This single-center interventional evaluation will measure patients' ability to manipulate the pump of their penile prosthesis and relate those abilities to erection rigidity and patient (and partner) sexual satisfaction. Adults who had a penile prosthesis implanted more than three months prior and who can consent will be enrolled, while those with known device dysfunction will be excluded. Measurements will combine direct testing of pump manipulation, clinical assessment of rigidity during inflation, and questionnaires about satisfaction. The research is conducted at the Department of Urology, Lyon Sud Hospital, with partner participation permitted.
Who should consider this trial
Good fit: Ideal candidates are adults with erectile dysfunction who received a penile prosthesis at least three months ago, can understand the research, and can provide informed consent (partners may also participate).
Not a fit: Patients with a mechanically dysfunctional prosthesis, those within three months of implantation, adults under legal protective measures, or those not affiliated with a social security scheme are unlikely to benefit from this evaluation.
Why it matters
Potential benefit: If successful, the results could identify barriers to effective device use and guide training, device design changes, or patient selection to improve sexual function and satisfaction.
How similar studies have performed: This appears to be a novel evaluation—no prior studies have directly measured pump manipulation ability and its association with erection rigidity and satisfaction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patients will be included based on the following criteria: * Adults * Erectile Dysfunction, and had undergone penile prosthesis implantation for more than 3 months * Able to comprehend the nature and purpose of the research * Having provided informed consent The partner will be included based on the following criteria : * Adults * Having a partner who meets the inclusion criteria * Able to comprehend the nature and purpose of the research * Having provided informed consent Exclusion Criteria: * Patients with a dysfunctional penile prosthesis (reservoir, pump, or cylinders anomaly) * Adults subject to legal protective measures. * Individuals not affiliated with a social security scheme or beneficiaries of a similar scheme.
Where this trial is running
Pierre-Bénite
- Department of Urology, Lyon Sud Hospital, — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Nicolas MOREL-JOURNEL
- Email: nicolas.morel-journel@chu-lyon.fr
- Phone: + 33 4 72 6788 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.