Intra‐cavernous injection of BOTOX^® (50 and 100 Units) for treatment of vasculogenic erectile dysfunction: Randomized controlled trial

Abstract

Background: Erectile dysfunction (ED) is a socioeconomic problem.There are several options for its management including intra-cavernosal injection (ICI).Objective: To compare the safety, efficacy, and durability of ICI of onabotulinum toxin-A (BTX) in different doses (50 and 100 U) against placebo (saline) in the management of vasculogenic ED non-responding to pharmacological therapy (phosphodiesterase type 5 inhibitors or/and ICI of trimix). Materials and Methods:A prospective randomized double-blind placebo-controlled trial was conducted between July 2016 and February 2019. A total of 176 patients were randomly assigned (1:1:1) to one of the treatment sequences: Botox 100 U group (BTX-100; 62 patients), Botox 50 U group (BTX-50; 59 patients), or placebo group (55 patients). All patients were followed up for 6 months.Results: Significant improvement in all parameters, that is, SHIM score & Erection Hardness Score (EHS), Sexual Encounter Profile (SEP), Global Assessment Score (GAS), and Doppler parameters (p < 0.001) was observed in patients of BTX-100 and BTX-50 groups with maximum improvement at 3rd month of treatment. Around 40% of patients were responders and were able to engage in sexual intercourse. Patients in placebo group did not experience significant improvement (p = 0.264). It was noted that at the 2nd week and 3rd months after treatment, there was no statistically significant difference in the improvement of these parameters in BTX-100 and BTX-50 groups (p > 0.05). In the 6th month, there was a statistically significant difference between the aforementioned groups in favor of BTX-100 (p < 0.01). Conclusions:Only one-time ICI of BTX (50 U and 100 U) is effective and safe for the treatment of refractory ED. This agent has a considerable long duration of action, particularly BTX-100U seems to be more durable.

Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin®) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series

“…Since the potency of Botox ® and Xeomin ® is identical, they can be compared using a 1:1 conversion ratio [21]. Studies have repeatedly reported the effectiveness of a 100U dose of onabotulinumtoxinA in difficult-to-treat ED [14,16,17]; therefore, we used the same dose of incobotulinumtoxinA in the present study. The conversion ratio between onabotulinumtoxinA (or incobotulinumtoxinA) and abobotulinumtoxinA is more debated [20].…”

“…The first follow-up assessment was performed 43.5 (34-71) days post-injection. EFdomain score post-injection was 21 (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26). A total of 28/54 (52%) men responded: their EF domain score was 26 (22)(23)(24)(25)(26)(27)(28)(29), corresponding to an increase of 8 (6-15) points from baseline.…”

“…The treatments for which the response was insufficient were PDE5-Is highest approved dose on demand (sildenafil 100 mg, vardenafil 20 mg, or tadalafil 20 mg) or daily (tadalafil 5 mg) for 43/54 men (80%) and/or PGE1 ICI (mean (SD) dose 42 (20) µg for 12/54 men (22%)). The median baseline EF domain score on treatment, i.e., prior to incobo-tulinumtoxinA ICI was 13 (8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19). The severity of ED on pharmacological treatment prior to incobotulinumtoxinA ICI according to EF-domain score [19] in the 54 participants was mild, moderate, and severe in respectively 22 (41%), 13 (24%), and 19 (35%) men.…”

“…Three men were not assessed after the 2nd injection. For the 17 men who were assessed at the time of the 2nd injection, the EF score was 18 (16)(17)(18)(19)(20)(21) points and increased to 27 (21)(22)(23)(24)(25)(26)(27)(28)(29) points 35 (29-37) days post 2nd injection (their EF score at baseline was 17 [12][13][14][15][16][17][18][19][20][21] points). After the 2nd injection, 13/17 (76%) men responded compared to baseline.…”

“…A growing body of evidence suggests that off-label BoNT/A intracavernosal injections (ICI) can improve erectile function in ED that responds insufficiently to registered pharmacological treatments. The results of preliminary studies suggest that two BoNT/A products, onabotulinumtoxinA (Botox ® ; Allergan Inc., Irvine, CA, USA) and abobotulinum-toxinA (Dysport ® ; Ipsen, Slough, UK/Galderma, Paris, France) may effectively treat this condition [13][14][15][16][17]. OnabotulinumtoxinA and abobotulinumtoxinA formulations contain the neurotoxin as part of a larger protein complex with complexing (accessory) proteins that are not required for the pharmacological activity of the neurotoxin.…”