Ignite Creation Date:
2024-05-06 @ 2:41 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04390230
Status:
UNKNOWN
Last Update Posted:
2020-05-15
First Post:
2020-05-12
Brief Title:
Inflatable Penile Prostheses Which Patients Can Correctly Use the Scrotal Pump
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Inflatable Penile Prostheses Predicting Factors of Pump Misuse and Unsatisfaction
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Sexual health and satisfaction are well know as critical critera to assess quality of life at any age Among the multiple aspects of sexual health erectile dysfunction ED is not anymore a fate mainly thanks to the advent of phosphodiesterase type 5 PDE5 inhibitors in 1998 Nevertheless a significant part of patients are intolerant or does not respond to PDE5 inhibitors and thus are looking for other treatment options
Since the first implantation of foreign material intracarvernosally in 1966 by Beheri multiple modifications and enhancements were achieved in order to produce devices more reliable with a more natural appearance First introduced in 1973 by Scott et al inflatable prosthesis provides now high general satisfaction rates 69-94 better than in malleable prostheses except for few authors
In addition to changes in materials and construction the two main manufacturers of IPP Boston scientific AMS Marlborough MA USA and Coloplast Minneapolis MN USA modernized the pump mechanism of their devices Since the introduction of AMS IPP three main pump formats have been used the standard pump has been replaced in 2004 by the Tactile pump and then the Momentary Squeeze MS pump in 2006 smaller and easier to deflate by not requiring the patient to hold the deflation button throughout deflation Coloplast also replaced in 2008 their Genesis pump by a One Touch Release OTR pump and finally in 2014 by the current Touch pump smaller and presenting a biconcave deflation button easier to find
Despite all technological advances appropriate pre-operative counselling and careful post-operative teachning a significant part of patients has still difficulties to handle the pump and thus does not use their IPP regardless of any material malfunction That situation obviously leads to patients dissatisfaction and highlights the operating risks of a useless surgical procedure
The purposes of this study wereto identify the risks factors modifiable and non-modifiable for patients difficulty to inflate andor deflate their device after IPP implantation then to show a correlation between easy handling and post-operative satisfaction And last but not least to show an association between pre-operative pump pattern viewing and handling and post-operative easy handling That information could help the physicians to improve the pre-operative selection of patients and to adapt the peri-operative care in order to improve patients satisfaction
Since the first implantation of foreign material intracarvernosally in 1966 by Beheri multiple modifications and enhancements were achieved in order to produce devices more reliable with a more natural appearance First introduced in 1973 by Scott et al inflatable prosthesis provides now high general satisfaction rates 69-94 better than in malleable prostheses except for few authors
In addition to changes in materials and construction the two main manufacturers of IPP Boston scientific AMS Marlborough MA USA and Coloplast Minneapolis MN USA modernized the pump mechanism of their devices Since the introduction of AMS IPP three main pump formats have been used the standard pump has been replaced in 2004 by the Tactile pump and then the Momentary Squeeze MS pump in 2006 smaller and easier to deflate by not requiring the patient to hold the deflation button throughout deflation Coloplast also replaced in 2008 their Genesis pump by a One Touch Release OTR pump and finally in 2014 by the current Touch pump smaller and presenting a biconcave deflation button easier to find
Despite all technological advances appropriate pre-operative counselling and careful post-operative teachning a significant part of patients has still difficulties to handle the pump and thus does not use their IPP regardless of any material malfunction That situation obviously leads to patients dissatisfaction and highlights the operating risks of a useless surgical procedure
The purposes of this study wereto identify the risks factors modifiable and non-modifiable for patients difficulty to inflate andor deflate their device after IPP implantation then to show a correlation between easy handling and post-operative satisfaction And last but not least to show an association between pre-operative pump pattern viewing and handling and post-operative easy handling That information could help the physicians to improve the pre-operative selection of patients and to adapt the peri-operative care in order to improve patients satisfaction
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