Assessment of the intracavernosal injection platelet‐rich plasma in addition to daily oral tadalafil intake in diabetic patients with erectile dysfunction non‐responding to on‐demand oral PDE5 inhibitors

Abstract

This study aimed to evaluate the effectiveness of ICI of platelet‐rich plasma (PRP) in addition to daily oral tadalafil intake in diabetic erectile dysfunction (ED) patients non‐responding to PDE5 inhibitors. Overall, 48 patients complaining of ED non‐responding to on‐demand PDE5 inhibitors were allocated into 2 equal groups, diabetics and non‐diabetics that were given a daily dose of 5 mg tadalafil plus vardenafil 20 mg on demand during the study besides being subjected to 3 doses of ICI of PRP, 4 weeks apart. Responses to on‐demand PDE5 inhibitors, International index of erectile function‐5 (IIEF‐5) score, erection hardness scores (EHS) and pharmaco‐dynamic duplex studies were assessed. After PRP injections, 33% and 50% of cases were satisfied with on‐demand PDE5 inhibitors, respectively, whereas 41% and 66% of them showed improved EHS response. Compared with baseline scores, the mean IIEF‐5 scores were significantly improved after PRP therapy in the diabetic ED group (12.1 vs. 8.04, p = 0.003) as well as in the non‐diabetic ED group (14.8 vs. 10.2, p = 0.001) linked to pharmaco‐penile duplex readings. Both good and fair diabetic control exhibited significant responses to ICI therapy of PRP compared with bad controlled cases. The significant improvement included; the IIEF‐5 score increase (86.7%, 126% vs. 16.1%), improved EHS as well as penile duplex readings. Baseline HbA1C demonstrated a significant negative correlation with IIEF‐5 score before (p = 0.019) and after PRP therapy (p = 0.002) respectively. It could be concluded that ICI of PRP could be an effective therapy for treating ED patients non‐responding to on‐demand oral PDE5 treatment.

Platelet-rich plasma therapy in erectile dysfunction and Peyronie’s disease: a systematic review of the literature

“…All studies evaluated erectile function improvements using either the 5-item or the erectile function domain of the International Index of Erectile Function questionnaire (IIEF-5 and IIEF-EF, respectively) [14,15]. Four studies also used penile duplex ultrasound to investigate end-diastolic velocity (EDV), peak systolic velocity (PSV), resistivity index (RI) and mean artery diameter [16][17][18]. Side effects were generally limited and included mild pain, bruising and development of a small fibrotic plaque in a single patient [19].…”

“…Each injection was repeated weekly for 6 weeks LiSWT protocol comprised 300 shocks in 5 anatomical sites of the penis during a 3-min session twice per week for 3 weeks; patients received 2 sessions after a 3-weeks interval Follow up: 3 months The mean (SD) score in IIEF-5 for LESWT and PRP was 20.21 and 21.26 at 12th week ( p > 0.05) with no statistically significant difference. The EHS and SEAR improvement after 12 weeks was not statistically significant Two participants reported local transient penile pain Small sample size; no randomization; no placebo group; short follow up period Zaghloul [ 18 ] 2021 Prospective Cohort Study 34 patients Mean age (SD): 50.18 (± 8.64) years Inclusion criteria: ED for > 6 months not responding to oral on-demand or daily PDE-51; regular sexual intercourses (1 per week) Exclusion criteria: Peyronie’s disease; use of drugs that affect erectile dysfunction (i.e. psychotropic medications); psychogenic disorders; Not applicable: all patients received oral daily dose of 5 mg tadalafil with oral on-demand vardenafil 20 mg (included only non-responders) Autologous PRP without activation factors.…”

“…Pressure applied on the root of the penis for 1–2 min and massage of the penis for 1–2 min to distribute the PRP. 3 months follow-up Mean ED duration: 26.5 ± 23.83 months, IIEF-5 score change -5.5, ± 5.2, p = < 0.001 (before 7.7059 ± 2.73617, after 13.2059 ± 6.77240), no change in EDV, PSV, RI or arterial diameter (assessed using 20 µg PGE1) None reported Small sample size, no randomization, no control group, short follow-up Zaghloul [ 18 ] 2022 Prospective Cohort Study Group 1: 24 patients with ED and diabetes, mean age (SD) 50.16 (± 6.89) years, Group 2: 24 non-diabetic ED patients, mean age (SD): 52.33 (± 5.17) years Inclusion criteria: ED patients not responding to on demand PDE-5i Exclusion criteria: Peyronie’s disease; psychotropic medications; major tranquillizers; smoking status Diabetic/non-diabetic ED patients, all patients received oral daily dose of 5 mg tadalafil with oral on-demand vardenafil 20 mg (included only non-responders) and PRP Autologous PRP PRP injected with 7-9 ml PRP in total. The patients were injected 3 times at monthly intervals.…”

“…Even though a high percentage of positive results have been reported by both groups, the mean IIEF-5 score improvement at 12-weeks follow up was not statistically significant ( p > 0.005) [ 23 ]. Two more prospective case series were conducted by Zaghloul et al [ 17 , 18 ]. In both studies, PDE5-I non-responders were prescribed a daily dose of 5 mg tadalafil and 20 mg vardenafil on demand and subjected to a PRP injections.…”

Erectile dysfunction: Is platelet-rich plasma the new frontier for treatment in patients with erectile dysfunction? A review of the existing evidence

“…Other studies have been done evaluating the combination therapy of Li-SWT and PRP (as well as other combination treatments), however some of these studies lack control groups and thus cannot be used to evaluate the effects of PRP alone in ED ( 43 , 44 , 49 , 50 ). It should be noted that Li-SWT has not been proven unequivocally to be of benefit in ED, with data from prospective randomized trials showing conflicting results ( 7 ).…”