NCT06851598

Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle for Premature Ejaculation

Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle in Treatment of Premature Ejaculation

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Abdallah Mohamed Abdallah Mohamed Elgendy · Academic / Other
• Sex: Male
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this work is to assess the efficacy and safety of Botulinum toxin - A injection into ischiocavernosus muscle in treatment of primary premature ejaculation.

Detailed description

Premature ejaculation (PE) is among the most common sexual dysfunctions of men (Porst et al., 2007; Waldinger et al., 2004). It affects more than 50% of men in some populations (Irfan et al., 2020). PE has negative impacts on these men's quality of life, as well as their sexual partners (Rosen \& Althof, 2008; Sridharan et al., 2018). The International Society for Sexual Medicine (ISSM) defines PE based on three criteria: the men who have from the first intercourse persistently occurring ejaculation in ≤ 1 min of intercourse (lifelong PE) or significantly reduced ejaculation time (≤ 3 min) later in life (acquired PE), failed to delay ejaculation almost all the time of sexual intercourse, and have developed negative personal and mental conditions (e.g., bother, frustration, distress) and eventually sexual avoidance (Serefoglu et al., 2014). Two types of PE have been widely recognized, ie, lifelong (primary) and acquired (secondary) PE. Lifelong PE is present from the first sexual experience onwards, occurs in almost all attempts at intercourse, and is considered to have a neurobiological etiology. Secondary PE occurs later in life after a period of perceived normal ejaculatory control, and may have a psychological and neurobiological etiology. This type of PE may be triggered by stress or linked to adverse events associated with medications (McCarty E \& Dinsmore W, 2012). Treatment of PE varied from behavioral techniques, selective serotonin reuptake inhibitors and local anesthetics with reported variable outcomes, unsatisfactory for many patients (Hanafy S et al.,2019). New lines have been always evolving trying to address this resistant category of patients such as injection of the glans penis with filler (Abdallah H et al.,2012) and neurectomy of the dorsal nerve of the penis (Liu Q et al.,2019). Ejaculation is a spinal cord reflex, which is constituted by emission and expulsion phases (Giuliano F \& Clement P,2005). During expulsion, rhythmic contractions of the bulbospongiosus and ischiocavernosus muscles propel semen antegrade through the bulbar and penile urethra. Botulinum-A toxin is a selective blocker of acetylcholine release from nerve endings and inhibits neural transmission when injected into muscle (Whelchel DD et al.,2004). The ischiocavernosus muscle (ICM) encompasses a pair of short pinnate muscles attached to the pelvic ring. This muscle originates at the ischial tuberosity and ends at the crus of the penis while covering the surface of the crus (Hsu GL et al.,2004). The concept of inhibiting stereotyped rhythmic contractions of the bulbospongiosus muscle with Botulinum toxin - A injection for the treatment of lifelong premature ejaculation was initially suggested in 2010 (Serefoglu and Silay, 2010).

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	25 units botox	25 units of botox injection into ischiocavernosus muscle
DRUG	50 units Botox	50 Units botox injection into ischiocavernosus muscle
DRUG	75 units Botox	75 units botox injection into ischiocavernosus muscle

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-02-01
• Completion: 2025-03-01
• First posted: 2025-02-28
• Last updated: 2025-02-28

Locations

1 site across 1 country: Egypt