Safety and efficacy of botulinum neurotoxin in the treatment of erectile dysfunction refractory to phosphodiesterase inhibitors: Results of a randomized controlled trial

Background There has been recent interest in the use of botulinum neurotoxin (BoNT) in the field of Andrology, whereby it has been investigated in the treatment of penile retraction and premature ejaculation. Objectives To evaluate the safety and efficacy of intracavernosal BoNT‐A injection in the t...

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Bibliographic Details
Published in:Andrology (Oxford) 2022-02, Vol.10 (2), p.254-261
Main Authors: Abdelrahman, Islam Fathy Soliman, Raheem, Amr Abdel, Elkhiat, Yaser, Aburahma, Abdelrahman A., Abdel‐Raheem, Tarek, Ghanem, Hussein
Format: Article
Language:English
Subjects:
Blood Flow Velocity - drug effects
BOTOX
Botulinum Neurotoxin
Botulinum Toxins - administration & dosage
Double-Blind Method
Erectile Dysfunction
Erectile Dysfunction - drug therapy
Humans
Injections
Male
Middle Aged
Penile Erection - drug effects
Penis - blood supply
Penis - drug effects
Phosphodiesterase Inhibitors
Prospective Studies
Severity of Illness Index
Sexual Behavior - drug effects
Treatment Outcome
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Summary:Background There has been recent interest in the use of botulinum neurotoxin (BoNT) in the field of Andrology, whereby it has been investigated in the treatment of penile retraction and premature ejaculation. Objectives To evaluate the safety and efficacy of intracavernosal BoNT‐A injection in the treatment of patients with erectile dysfunction (ED) refractory to oral phosphodiesterase inhibitors (PDE5Is). Patients and methods A double‐blind randomized placebo‐controlled prospective comparative study conducted at one center and involved 70 patients with ED refractory to PDE5Is. At baseline, the following data were collected: erection hardness score (EHS), peak systolic velocity (PSV), end diastolic velocity (EDV), sexual health inventory for men (SHIM), and the sexual encounter profile 2&3 (SEP‐2&3) questionnaires. Treatment group (n = 35) received a single ICI of 100 units of BoNT‐A in 2 ml of saline and control group (n = 35) received a single ICI of 2 ml of saline. EHS, PSV, and EDV were assessed at 2 weeks post treatment. SHIM, SEP‐2, SEP‐3, and global assessment questionnaire (GAQ‐Q1&Q2) were completed at 2‐, 6‐, and 12‐weeks post treatment. Results Two weeks post treatment, the treatment group showed a statistically significant improvement in the mean EHS, PSV, EDV, and GAQ‐Q1 positive responders (p 
ISSN:2047-2919
2047-2927
DOI:10.1111/andr.13104