Dual-Site Botulinum Toxin Type A Injection for Lifelong Premature Ejaculation (DUAL - PE)

March 15, 2026 updated by: HAITHAM ABDALLA, Al Mouwasat Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabia, 11536
        • Department of Urology Al Mouwasat Hospital Riyadh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BOTULINUM TOXIN TYPE A
Botulinum toxin type A was injected into the bulbospongiosus muscle and glans penis according to a standerdized protocol. this intervention was designed to modulate neuromuscular activity involved in the ejaculatory reflex
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
Placebo Comparator: placebo
placebo injection were administered into the bulbospongiosus muscle and the glans penis using the same procedure and volume as the experimental intervention
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
Other Names:
  • sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 6 months after intervention
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
Baseline to 6 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 6 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al Mouwasat Hospital

Investigators

  • Principal Investigator: Haitham Abdalla Shello, MD, AL MOUWASAT HOSPITAL ,RIYADH SAUDI ARABIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMMS-PE-BoNTA-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in the article,along with the study protocol and statistical analysis plan,will be made available upon reasonable request to the corresponding author following publication

IPD Sharing Time Frame

beginning 3 months following publication and ending 5 years after publication

IPD Sharing Access Criteria

data will be available to researchers who provide a methodologically sound proposals and will be reviewed by the corresponding author. Data will be shared after de-identification

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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