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Kitrey ND et al, 2015: Penile low-intensity shockwave treatment is able to shift PDE5i non-responders to responders: A double-blind sham-controlled study.

Kitrey ND, Gruenwald I, Appel B, Shechter A, Massarwa O, Vardi Y.
Neurourology Unit, Rambam Healthcare Campus, Israel.
Department of Family Medicine, Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Clalit Health Services, Haifa, Israel.
Urology Department, Sheba Medical Center, Tel-Hashomer, Israel.

Abstract

PURPOSE: Sham-controlled evaluation of penile low-intensity shockwave treatment (LIST) effect on patients unable to have sexual intercourse with phosphodiesterase 5 inhibitors.

MATERIALS AND METHODS: A prospective randomized double-blind sham-controlled study on vasculogenic ED patients who stopped using PDE5i due to no efficacy. All patients had an erection hardness score (EHS) ≤2 with PDE5i. 58 patients were randomized. Two-thirds (37 patients) were treated with LIST (12 sessions, 1500 pulses of 0.09 mJ/mm2, 120/min shockwaves). 18 patients were treated with a sham probe. 16 patients of the sham group were treated with LIST one month after the sham treatment. All Patients were evaluated at baseline and one month after the end of treatment using validated ED questionnaires and flow mediated dilatation (FMD) technique for penile endothelial function. Evaluation of erectile function was performed while patients were taking PDE5i.

RESULTS: 54.1% of the LIST group vs. none in the sham group had an erection hard enough for vaginal penetration (EHS=3) (p<0.0001). According to the changes in IIEF-EF domain score, treatment was effective in 40.5% of the LIST patients, and in none of the patients in the sham group (p=0.001). 56.3% of the patients treated with active LIST after sham treatment achieved an erection hard enough for penetration (p<0.005).

CONCLUSIONS: LIST is effective even in severe ED patients, who are PDE5i non-responders. After treatment, about half of them are able to achieve (with PDE5i) an erection hard enough for penetration. Longer follow-up is needed for establishing the place of LIST in these challenging patients.

J Urol. 2015 Dec 13. pii: S0022-5347(15)05422-1. doi: 10.1016/j.juro.2015.12.049. [Epub ahead of print] 

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Comments 1

Peter Alken on Friday, 13 May 2016 08:12

Impressive results.

A few things are difficult to understand before the treatment:
”patients included in the study were previous PDE5i responders (were able to have satisfactory intercourse with PDE5i according to their report), and stopped using PDE5i due to lack of efficacy less than 12 months before screening. At baseline, all of them were not able to achieve an erection hard enough for vaginal penetration after taking maximal dosage of PDE5i at their preference (erection hardness score (EHS) ≤ 2).” And then the study protocol required “After primary screening, all participants had a 4-week run-in period, during which they had sexual intercourse at least once a week after taking maximal dosage of one of the PDE5i “ How could they have intercourse in the run in phase if they were not able to achieve an erection ?

and after the treatment:
“no patient in the sham group had an erection that was hard enough for vaginal penetration” but concerning the CGIC (Clinical Global Impression of Change) questionnaire 21 patients (56.8%) from the LIST group reported clinical improvement (CGIC = +1/+2) vs. only 5 patients (27.8%) from the sham group. The statistical analysis approached but did not achieve significance (p=0.051).” Does it mean they felt better without performing better?

Impressive results. A few things are difficult to understand before the treatment: ”patients included in the study were previous PDE5i responders (were able to have satisfactory intercourse with PDE5i according to their report), and stopped using PDE5i due to lack of efficacy less than 12 months before screening. At baseline, all of them were not able to achieve an erection hard enough for vaginal penetration after taking maximal dosage of PDE5i at their preference (erection hardness score (EHS) ≤ 2).” And then the study protocol required “After primary screening, all participants had a 4-week run-in period, during which they had sexual intercourse at least once a week after taking maximal dosage of one of the PDE5i “ How could they have intercourse in the run in phase if they were not able to achieve an erection ? and after the treatment: “no patient in the sham group had an erection that was hard enough for vaginal penetration” but concerning the CGIC (Clinical Global Impression of Change) questionnaire 21 patients (56.8%) from the LIST group reported clinical improvement (CGIC = +1/+2) vs. only 5 patients (27.8%) from the sham group. The statistical analysis approached but did not achieve significance (p=0.051).” Does it mean they felt better without performing better?
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