NCT06376513 Evaluation of Penile Prosthesis Pump Manipulation
| NCT ID | NCT06376513 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Penile Prosthesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-14 |
| Primary Completion | 2026-12-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-06-14 with a primary completion date of 2026-12-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Erectile dysfunction is a highly prevalent pathology. When oral or injectable pharmacological treatments prove ineffective, the treatment of choice is penile prosthesis which provides the possibility of sexual activity with penetration. Unfortunately, current prostheses are difficult (or even impossible) to manipulate for some patients. Many patients underutilize their device due to difficulties in using the pump related to mechanical issues (difficult grip, lack of strength, etc.) or sensory issues (altered proprioception, etc.), resulting in an inability to achieve rigidity that allows optimal satisfaction for the patient and/or partners. These difficulties correspond to a significant portion of dissatisfaction among patients with penile prostheses. Actually, no study has evaluated patients' ability to manipulate the pump of their penile prosthesis, as well as the association between these manipulation abilities, the rigidity of erections with a penile prosthesis, and patient and partner sexual satisfaction. In this descriptive study, the primary outcome is to describe the manipulation abilities of patients with penile prostheses during follow-up consultations after prosthesis implantation. The secondary outcomes are to estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with * Rigidity of erections with penile prosthesis * Patient's sexual satisfaction * Partner's sexual satisfaction * Satisfaction related to pump manipulation
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06376513 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Penile Prosthesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06376513 currently recruiting?
Yes, NCT06376513 is actively recruiting participants. Contact the research team at nicolas.morel-journel@chu-lyon.fr for enrollment information.
Where is the NCT06376513 trial being conducted?
This trial is being conducted at Pierre-Bénite, France.
Who is sponsoring the NCT06376513 clinical trial?
NCT06376513 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 60 participants.