Evaluation of Penile Prosthesis Pump Manipulation
Recruiting now · Not applicable
Conditions studied: Penile Prosthesis
In brief
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
Key facts
- Study ID
- NCT06376513
- Run by
- Hospices Civils de Lyon
- People needed
- 60
- Starts
- 2024-06-14
- Expected to finish
- 2026-12-14
- Last updated by the study team
- 2026-01-23
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Department of Urology, Lyon Sud Hospital, — Pierre-Bénite, France (enrolling)
Full record on ClinicalTrials.gov
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