An interventional study of Evaluation in Penile Prosthesis, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
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
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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The partner will be included based on the following criteria :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Describing the manipulation abilities of patients with penile prosthesis : overall hand grip strength
Measurement of overall hand grip strength using the JAMAR dynamometer. The force is expressed in kg.
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
Measurement of pinch grip strength using the "pinch test".The force is expressed in kg.
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
Measurement of proprioception with a object recognition test : the "Moberg pick-up test". The patient must recognize (with eyes closed) objects that he has previously seen and held in his hand. A score ranging from 0 to 12 will thus be obtained.
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
Measurement of discrimination with a two points touch test. Evaluation of the smallest perceived distance between two points, expressed in mm.
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
Evaluation of upper limb function for activities of daily living: the Quick DASH (Disabilities of the Arm, Shoulder and Hand). A score ranging from 11 to 55 will thus be obtained.
Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
Correlation of manipulation parameters (main outcome) with rigidity of erections
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. The patient will be asked to inflate his prosthesis under normal usage conditions. The physician will then apply the device to the erect penis and note the point of deformation of the penis (buckling). The result is expressed in grams. Manipulation of the penile prosthesis pump resulting in an erection rigidity exceeding 550g will be considered adequate
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
To estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with patient's sexual satisfaction (modified EDITS). The responses to the EDITS questionnaire are given on a Likert scale ranging from 0 to 4 for each item. A score of 0 corresponds to maximum dissatisfaction, and a score of 4 corresponds to maximum satisfaction. A score ranging from 0 to 36 will thus be obtained. For each item, satisfaction is deemed sufficient if the Likert score obtained is ≥ 3.
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
To estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with patient's sexual satisfaction ( QoLSPP). The responses to the QoLSPP questionnaire are given on a Likert scale ranging from 0 to 5 for each item. A score of 0 corresponds to maximum dissatisfaction, and a score of 5 corresponds to maximum satisfaction. A score ranging from 0 to 80 will thus be obtained. For each item, satisfaction is deemed sufficient if the Likert score obtained is ≥ 3.
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
To estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with partner's sexual satisfaction (partner modified EDITS) The responses to the partner EDITS questionnaire are given on a Likert scale ranging from 0 to 4 for each item. A score of 0 corresponds to maximum dissatisfaction, and a score of 4 corresponds to maximum satisfaction. A score ranging from 0 to 20 will thus be obtained. For each item, satisfaction is deemed sufficient if the Likert score obtained is ≥ 3.
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)
To estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with satisfaction related to pump manipulation (self-made questionnaire) The responses to this questionnaire will also be provided on a Likert scale ranging from 0 to 4 for each item. A score of 0 corresponds to complete inability to perform the act, and a score of 4 corresponds to performing the act without any difficulty. A score ranging from 0 to 24 will thus be obtained. For each item, satisfaction related to pump manipulation is deemed sufficient if the Likert score obtained is ≥ 3.
Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
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