Clinical trial NCT06376513: Evaluation of Penile Prosthesis Pump Manipulation
Official title: Evaluation of Penile Prosthesis Pump Manipulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Penile Prosthesis
Keywords: Erectile dysfunction
Penile prosthesis
Manipulation difficulties
Erection's rigidity
Sexual satisfaction
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Primary outcomes:
measure: Describing the manipulation abilities of patients with penile prosthesis : overall hand grip strength
timeFrame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
measure: Describing the manipulation abilities of patients with penile prosthesis : pinch grip strength
timeFrame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
measure: Describing the manipulation abilities of patients with penile prosthesis : proprioception
timeFrame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
measure: Describing the manipulation abilities of patients with penile prosthesis :discrimination
timeFrame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
measure: Describing the manipulation abilities of patients with penile prosthesis :upper limb function for activities of daily living
timeFrame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
Secondary outcomes:
measure: Correlation of manipulation parameters (main outcome) with rigidity of erections
timeFrame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
measure: Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction modified EDITS
timeFrame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
measure: Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction QoLSPP
timeFrame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
measure: Correlation of manipulation parameters (main outcome) with partner's sexual satisfaction
timeFrame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
measure: Correlation of manipulation parameters (main outcome) with satisfaction related to pump manipulation (self-made questionnaire)
timeFrame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Department of Urology, Lyon Sud Hospital,
Study officials:
References: