Evaluation of Penile Prosthesis Pump Manipulation

Overview

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

Interventions

• Other Evaluation
  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

Primary outcome measures

• Describing the manipulation abilities of patients with penile prosthesis : overall hand grip strength [Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)]
• Describing the manipulation abilities of patients with penile prosthesis : pinch grip strength [Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)]
• Describing the manipulation abilities of patients with penile prosthesis : proprioception [Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)]
• Describing the manipulation abilities of patients with penile prosthesis :discrimination [Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)]
• Describing the manipulation abilities of patients with penile prosthesis :upper limb function for activities of daily living [Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)]

Secondary outcome measures (5)

• Correlation of manipulation parameters (main outcome) with rigidity of erections [Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)]
• Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction modified EDITS [Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)]
• Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction QoLSPP [Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)]
• Correlation of manipulation parameters (main outcome) with partner's sexual satisfaction [Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)]
• Correlation of manipulation parameters (main outcome) with satisfaction related to pump manipulation (self-made questionnaire) [Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

France · 1 center

• Department of Urology, Lyon Sud Hospital, — Pierre-Bénite

Identifiers

NCT: NCT06376513 · 69HCL24_0031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗