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OpenTrials
Completed

NCT Number: NCT07426640

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

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.

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Key information

Conditions

Premature (Early) Ejaculation Ejaculatory Dysfunction Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Ejaculation Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology Al Mouwasat Hospital Riyadh

Riyadh, Riyadh Region, 11536, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

male participants aged 20 years or older . diagnosis with lifelong premature ejaculation, in a stable heterosexual relationship for at least 6 months prior to enrollment, engaged in vaginal intercourse during the study period, willing and able to provide written informed consent -

Exclusion criteria

presence of acquired premature ejaculation, history of erectile dysfunction require treatment , current use of medication known to affect ejaculation or sexual function ,previous treatment with botulinum toxin for sexual dysfunction ,history of sever neurological or psychatricor endocrine disorders affection sexual function , active genital infection or penile anatomical abnormalities , hypersensitivity to botulinum toxin ,mythenia gravis

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Treatment and study plan

BoNT-A

Drug

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

Placebo injection (normal saline)

Drug

injection of equivalent amount of normal saline by same technique and mechanism into the bulbospongiosus muscle and the glans penis

Other names: sodium chloride

Primary outcomes

  1. intravaginal ejaculatory latency time (IELT )

    Time frame: Baseline to 6 months after intervention

    intravaginal ejaculatory latency time was defined as the time from vaginal penetrationto ejaculation . measured by stopwatch in minutes or seconds

  2. Intravaginal Ejaculatory Latency Time ( IELT)

    Time frame: Baseline to 6 months after intervention

    (IELT) was defined as the time from vaginal penetration to ejaculation, measured in minutes using a stopwatch

Secondary outcomes

  1. sexual satisfaction

    Time frame: Baseline to 6 months after intervention

    sexual satisfaction was assessed using a validated patient-reported questionnaire completed by participants during the study follow up period which reflect quality of life

Sponsors and collaborators

Lead sponsor

Al Mouwasat Hospital

Other

Registry information

Official study title

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

Acronym: DUAL - PE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 23, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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