(067) The Outcome of Bulbospongiosus Muscle Injection with Botulinum-A Toxin for Treatment of Lifelong Premature Ejaculation; A Randomized Controlled Trial

Lifelong premature ejaculation (PE) is considered one of the commonest sexual disorder affecting men with an estimated prevalence of 2–5%. [1,2] Many definitions have been proposed for lifelong PE, the most accepted is the ISSM’s which consider PE “ejaculation which always or nearly always occurs prior to or within about 1 minute of vaginal penetration from first sexual experiences (lifelong premature ejaculation) + Negative personal consequences such as distress, bother, frustration, and/or the avoidance of sexual intimacy”.[3] However, there is no doubt that lifelong PE negatively affects the quality of life of the patient and his partner. [2] Proper assessment of this problem in an objective validated way has always been a challenge. [4] Treatment also varied from behavioral techniques, SSRIs and local anaesthetics with very variable outcome, unsatisfactory for many patients. [5] New lines have been always evolving trying to address this resistant category of patients such as injection of the glans penis with filler [6] or neurectomy of the dorsal nerve of the penis. [7] Herein; we assess a new line of treatment for lifelong PE which theoretically can inhibit the stereotyped rhythmic contractions of the bulbospongiosus muscle during the reflex of ejaculation using botulinum-A toxin; in a prospective, randomized, placebo-controlled study. This study aimed to assess a new line of treatment for lifelong premature ejaculation (PE) which is botulinum-A toxin injection into the bulbospongiosus muscle. It was conducted at the Andrology Unit of Tanta University in Egypt between November 2020 and November 2022. Patients with lifelong PE were considered for this study. Those suffering from PE secondary to erectile dysfunction, genital infection or psychic stress were excluded. Patients have been asked to stop any medical treatment that could affect their sexual function eg PDE5i and medications for lifelong PE; for at least 1 month before injection as well as 6 months thereafter. Sixty patients with lifelong PE have been prospectively enrolled and randomized into 2 groups; the test group (group A) was injected with 100 U botulinum-A toxin at 10 U/ml and the control group (group B) which was injected with the same volume of saline into the bulbospongiosus muscle. Injection was done in lithotomy position, using a fanning technique, under US guidance using the superficial probe to localize the site of injection. Fifty-seven patients of 60 completed the follow up protocol. Fifty-seven patients of 60 completed the follow up protocol. The IELT, PEP score and female satisfaction showed no statistically significant difference between both groups at the 1, 3 and 6 months post intervention. However, in the treatment group, the median (IQR) PEP score increased significantly after 1 and 3 months with a mean difference of 1.6 and 95 % CI of (0.7–2.5), P=0.001 and 0.9 and 95% CI of (1.07–1.69), P=0.02 respectively. Whereas insignificant change was noted at 6 months, with a mean difference of 0.13.In the control group however, there was no significant change of any of the tested parameters at any the 3 time points. Adverse reactions were minor and observed only in 3 cases (5%). botulinum A injection into the BS muscle seems to be safe, but failed to prove efficacy when compared to placebo in treatment of lifelong PE No.