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. |
