NCT07426640

Dual-Site Botulinum Toxin Type A Injection for Lifelong Premature Ejaculation

A Randomized Double-Blind Placebo-Controlled Trial of Dual-Site Botulinum Toxin Type A Injection Into the Bulbospongiosus Muscle and Glans Penis for Lifelong Premature Ejaculation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Al Mouwasat Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Premature ejaculation is a common sexual condition that can cause distress for men and their partners. Different treatments are available, but some men do not respond well to standard therapies. This study was designed to evaluate whether injecting botulinum toxin type A into two areas of the penis and surrounding muscles can help delay ejaculation in men with lifelong premature ejaculation. Participants were randomly assigned to receive either botulinum toxin injections or placebo injections. The study evaluated ejaculation time, sexual satisfaction, and quality of life over a follow-up period of six months. Safety and possible side effects were also monitored during the study.

Detailed description

Lifelong premature ejaculation is a common male sexual disorder characterized by ejaculation that occurs with minimal sexual stimulation and causes personal distress. Although several pharmacological and behavioral treatment options are available, a subset of patients does not achieve satisfactory results or experiences side effects. Botulinum toxin type A has neuromodulatory properties that may influence ejaculatory reflex pathways. This randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of dual-site botulinum toxin type A injection in men with lifelong premature ejaculation. Eligible participants were randomly assigned to receive either botulinum toxin type A or placebo injections. Injections were administered into the bulbospongiosus muscle and the glans penis under standardized conditions. Participants were followed for six months after treatment. The primary outcome measure was intravaginal ejaculatory latency time. Secondary outcomes included patient-reported measures of sexual satisfaction, perceived control over ejaculation, and quality of life. Safety outcomes and adverse events were monitored throughout the study period

Conditions

• Premature (Early) Ejaculation

Interventions

Type	Name	Description
DRUG	BoNT-A	participants were randomly assigned to one of two parallel groups to receive either Botulinum toxin type A injection or placebo injections( normal saline ) and were followed prospectively also the dual site injection is new
DRUG	Placebo injection (normal saline)	injection of equivalent amount of normal saline by same technique and mechanism into the bulbospongiosus muscle and the glans penis

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2026-02-23
• Last updated: 2026-03-17

Locations

1 site across 1 country: Saudi Arabia