RecruitingNot ApplicableNCT06376513

Evaluation of Penile Prosthesis Pump Manipulation


Sponsor

Hospices Civils de Lyon

Enrollment

60 participants

Start Date

Jun 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria9

  • 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
  • Able to comprehend the nature and purpose of the research
  • Having provided informed consent

Exclusion Criteria3

  • 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.

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Interventions

OTHEREvaluation

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


Locations(1)

Department of Urology, Lyon Sud Hospital,

Pierre-Bénite, France

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NCT06376513