The impact of extracorporeal shock wave therapy for the treatment of young patients with vasculogenic mild erectile dysfunction: A prospective randomized single-blind, sham controlled study.
International Index of Erectile Function (IIEF)
erectile dysfunction
extracorporal shock wave therapy
treatment
Journal
Andrology
ISSN: 2047-2927
Titre abrégé: Andrology
Pays: England
ID NLM: 101585129
Informations de publication
Date de publication:
09 2021
09 2021
Historique:
revised:
16
03
2021
received:
01
12
2020
accepted:
19
03
2021
pubmed:
30
3
2021
medline:
25
2
2022
entrez:
29
3
2021
Statut:
ppublish
Résumé
Low-intensity extracorporeal shock wave therapy (ESWT) for the treatment of vasculogenic erectile dysfunction (ED) has emerged as a promising method directly targeting the underlying pathophysiology of the disease. To compare outcomes in ED patients after ESWT and placebo treatment. Prospective randomized placebo-controlled single-blinded trial on 66 patients with mild ED. The study comprised a 4-week washout phase, a 4-week treatment phase, and a 48-week follow-up. Inclusion criteria included age between 18 and 75 years and diagnosis of mild ED (IIEF-EF score = 17-25) being made at least six months prior to study inclusion and being confirmed by Penile Doppler ultrasonography (US) at baseline examination. Efficacy endpoints were changes from baseline in patient-reported outcomes of erectile function (International Index of Erectile Function domain scores [IIEF-EF]), as well as erection hardness and duration (Sexual Encounter Profile diary [SEP] and Global Assessment Questions [GAQ]). Safety was assessed throughout the study. A total of 66 enrolled patients were allocated to ESWT (n = 44) or placebo (n = 22). Mean age of ESWT and placebo group was 42.32 ± 9.88 and 39.86 ± 11.64 (p = 0.374), respectively. Mean baseline IIEF-EF scores of ESWT group and placebo were 20.32 ± 2.32 and 19.68 ± 1.55 respectively (p = 0.34). At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10 ± 2.82 vs. 20.95 ± 2.19, p = 0.003), and IIEF-EF scores of ESWT patients remained high during the 6 months (22.67 ± 3.35 vs. 19.82 ± 1.56) follow-up. The percentage of patients reporting both successful penetration (SEP2) and intercourse (SEP3) in more than 50% of attempts was significantly higher in ESWT-treated patients than in placebo patients (p = 0.001). A minimal clinically important difference between the IIEF = EF baseline and 3-months follow-up was found in 74% of ESWT and 36% of placebo. No serious adverse events were reported. ESWT significantly improved the erectile function of relatively young patients with vasculogenic mild ED when compared to placebo and the beneficial effect of this treatment up to 6 months. These findings suggest that ESWT could be a useful treatment option in vasculogenic ED.
Sections du résumé
BACKGROUND
Low-intensity extracorporeal shock wave therapy (ESWT) for the treatment of vasculogenic erectile dysfunction (ED) has emerged as a promising method directly targeting the underlying pathophysiology of the disease.
OBJECTIVES
To compare outcomes in ED patients after ESWT and placebo treatment.
MATERIALS AND METHODS
Prospective randomized placebo-controlled single-blinded trial on 66 patients with mild ED. The study comprised a 4-week washout phase, a 4-week treatment phase, and a 48-week follow-up. Inclusion criteria included age between 18 and 75 years and diagnosis of mild ED (IIEF-EF score = 17-25) being made at least six months prior to study inclusion and being confirmed by Penile Doppler ultrasonography (US) at baseline examination. Efficacy endpoints were changes from baseline in patient-reported outcomes of erectile function (International Index of Erectile Function domain scores [IIEF-EF]), as well as erection hardness and duration (Sexual Encounter Profile diary [SEP] and Global Assessment Questions [GAQ]). Safety was assessed throughout the study.
RESULTS
A total of 66 enrolled patients were allocated to ESWT (n = 44) or placebo (n = 22). Mean age of ESWT and placebo group was 42.32 ± 9.88 and 39.86 ± 11.64 (p = 0.374), respectively. Mean baseline IIEF-EF scores of ESWT group and placebo were 20.32 ± 2.32 and 19.68 ± 1.55 respectively (p = 0.34). At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10 ± 2.82 vs. 20.95 ± 2.19, p = 0.003), and IIEF-EF scores of ESWT patients remained high during the 6 months (22.67 ± 3.35 vs. 19.82 ± 1.56) follow-up. The percentage of patients reporting both successful penetration (SEP2) and intercourse (SEP3) in more than 50% of attempts was significantly higher in ESWT-treated patients than in placebo patients (p = 0.001). A minimal clinically important difference between the IIEF = EF baseline and 3-months follow-up was found in 74% of ESWT and 36% of placebo. No serious adverse events were reported.
DISCUSSION AND CONCLUSION
ESWT significantly improved the erectile function of relatively young patients with vasculogenic mild ED when compared to placebo and the beneficial effect of this treatment up to 6 months. These findings suggest that ESWT could be a useful treatment option in vasculogenic ED.
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1571-1578Subventions
Organisme : STORZ Medical Turkey
Informations de copyright
© 2021 American Society of Andrology and European Academy of Andrology.
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