Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376513
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-15
Brief Title:
Evaluation of Penile Prosthesis Pump Manipulation
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Evaluation of Penile Prosthesis Pump Manipulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECM3P
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 andor 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
Patients sexual satisfaction
Partners sexual satisfaction
Satisfaction related to pump manipulation
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 andor 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
Patients sexual satisfaction
Partners sexual satisfaction
Satisfaction related to pump manipulation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None