Ignite Creation Date:
2024-05-06 @ 3:31 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02304679
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2014-11-20
Brief Title:
Low Energy Shockwave Therapy for Improving Erectile Dysfunction
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
The Effectiveness of Low Energy Shockwave Therapy for Improving Erectile Dysfunction in Men a Double Blind Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-08
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:
Shock-ED
Brief Summary:
The primary objective of this study is to evaluate the change from baseline in the erectile function domain of the International Index of Erectile Function IIEF-EF scores in patients receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment The change will be evaluated at 3 months after the end of a sequence of 4 weekly treatments
Detailed Description:
The secondary objectives of this study are
A To evaluate erectile function EF categorical improvement in patients receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment at 3 months after a first sequence of treatment
B To compare improvements in erectile function between 4 weeks of phosphodiesterase type 5 inhibitor PDE5i use and 4 weekly treatments of shockwave therapy within patient effect
C To compare improvements in erectile function between 4 weeks of PDE5 inhibitor use and 4 weekly treatments of sham shock wave therapy within patient effect
D To evaluate the effect of a 2nd sequence of 4-8 weekly shock wave treatments 3 months after this second sequence
E To evaluate treatment effects the same comparisons as in objectives A B C D on other validated measure of EF question 2 of the sexual encounter profile SEP2 question 3 of the sexual encounter profile SEP3 Global Assessment Question GAQ Erection Hardness Scale EHS and the remaining domains of the IIEF score orgasmic function sexual desire intercourse satisfaction overall satisfaction as well as the total IIEF score
F To evaluate treatment tolerance and potential adverse events G To compare changes in EF measures over time for a follow-up period of 12 months following the second sequence of 4 weekly shock wave treatments
H To compare the effect of a sequence of 4 weekly shock wave treatments versus 8 biweekly shock wave treatments 3 months after the treatment within patient effect
A To evaluate erectile function EF categorical improvement in patients receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment at 3 months after a first sequence of treatment
B To compare improvements in erectile function between 4 weeks of phosphodiesterase type 5 inhibitor PDE5i use and 4 weekly treatments of shockwave therapy within patient effect
C To compare improvements in erectile function between 4 weeks of PDE5 inhibitor use and 4 weekly treatments of sham shock wave therapy within patient effect
D To evaluate the effect of a 2nd sequence of 4-8 weekly shock wave treatments 3 months after this second sequence
E To evaluate treatment effects the same comparisons as in objectives A B C D on other validated measure of EF question 2 of the sexual encounter profile SEP2 question 3 of the sexual encounter profile SEP3 Global Assessment Question GAQ Erection Hardness Scale EHS and the remaining domains of the IIEF score orgasmic function sexual desire intercourse satisfaction overall satisfaction as well as the total IIEF score
F To evaluate treatment tolerance and potential adverse events G To compare changes in EF measures over time for a follow-up period of 12 months following the second sequence of 4 weekly shock wave treatments
H To compare the effect of a sequence of 4 weekly shock wave treatments versus 8 biweekly shock wave treatments 3 months after the treatment within patient effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-A00486-41 | OTHER | RCB number | None |