Evaluation of Penile Prosthesis Pump Manipulation (ECM3P)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Penile Prosthesis

Treatments: Other: Evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT06376513

69HCL24_0031

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Patients who have undergone penile prosthesis implantation > 3 months ago and their partner

Other group

Description:

Evaluation of the manipulation abilities of patients with penile prostheses Evaluation of the rigidity of erections with penile prosthesis, the patient and partner's sexual satisfaction, the satisfaction related to pump manipulation

Treatment:

Other: Evaluation