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Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized Study

Hyaluronic Acid Versus Botox Injection in Treatment of Life Long Drug Resistant Premature Ejaculation. Which is Better? Randomized Study

NCT07236632•Benha University

View on ClinicalTrials.gov

Summary

Premature ejaculation (PE) is one of the most common male sexual dysfunctions, often resistant to conventional pharmacological and behavioral treatments. This randomized clinical trial aims to compare the safety and efficacy of two minimally invasive treatment options - hyaluronic acid (HA) injection into the glans penis versus botulinum toxin type A injection into the bulbospongiosus muscle - in men with lifelong drug-resistant premature ejaculation. Eighty participants will be randomly assigned in a 1:1 ratio to receive either HA or botulinum toxin injection. The primary outcome is change in intravaginal ejaculatory latency time (IELT). Secondary outcomes include changes in Premature Ejaculation Diagnostic Tool (PEDT), Arabic Index of Premature Ejaculation (AIPE) scores, Premature Ejaculation Profile (PEP), patient satisfaction, and treatment-related adverse events during a 12-month follow-up period.

Eligibility

Age

22 - 45 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Adult male patients aged 22 to 45 years.
•Sexually active and in a stable heterosexual relationship.
•Circumcised.
•Able to understand and comply with study procedures and follow-up visits.
•Diagnosed with lifelong drug-resistant premature ejaculation, defined as persistent ejaculation within one minute of penetration despite prior pharmacologic or behavioral therapy.
•Normal serum total testosterone, prolactin, and thyroid-stimulating hormone levels.
•Willing to provide written informed consent.

Exclusion Criteria

•Presence or history of erectile dysfunction or other sexual or ejaculatory disorders such as retrograde ejaculation or acquired premature ejaculation.
•History of acute or chronic prostatitis.
•Any debilitating medical condition including hepatic failure, renal failure, or uncontrolled diabetes mellitus.
•Previous pelvic or spinal surgery.
•Prior chemotherapy or radiotherapy.
•Use of antipsychotic or neuroactive medications that may affect ejaculation.
•History of substance abuse or current drug dependence.
•Presence of penile prosthesis, penile deformity, or anatomic abnormalities of the glans or shaft.
•Known hypersensitivity or allergy to botulinum toxin or hyaluronic acid preparations.
•Any condition that, in the investigator's opinion, may interfere with the safety or evaluation of the study treatment.

Key Dates

Start Date

December 15, 2025

Primary Completion Date

December 15, 2026

Completion Date

December 15, 2026

Last Updated

November 19, 2025

Enrollment

ESTIMATED participants

Conditions

Premature Ejaculation

Interventions

Botulinum toxin type A

DRUG

Hyaluronic acid

DRUG

Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)

NCT07434271

Premature Ejaculation

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RECRUITINGNA

Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial

NCT06570135

Premature Ejaculation

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COMPLETED

THE IMPACT OF VITAMIN B12 TREATMENT ON EJACULATORY FUNCTIONS IN MEN: SYMPTOMATIC RELIEF AND IMPROVED OUTCOMES

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized Study

Inclusion Criteria

Exclusion Criteria

Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)

Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial

THE IMPACT OF VITAMIN B12 TREATMENT ON EJACULATORY FUNCTIONS IN MEN: SYMPTOMATIC RELIEF AND IMPROVED OUTCOMES

Primary Premature Ejaculation Genetics

Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men

The Effect of Behavioral Therapy Given to Men and Their Partners'