Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-06-14
2026-12-14
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Patients who have undergone penile prosthesis implantation > 3 months ago and their partner
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
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
Interventions
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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
Eligibility Criteria
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Inclusion 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 Criteria
* Adults subject to legal protective measures.
* Individuals not affiliated with a social security scheme or beneficiaries of a similar scheme.
18 Years
MALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Department of Urology, Lyon Sud Hospital,
Pierre-Bénite, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69HCL24_0031
Identifier Type: -
Identifier Source: org_study_id
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