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

NCT ID: NCT07236632

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-12-15

Brief 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.

Conditions

Premature Ejaculation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Botulinum Toxin Injection Group

Participants in this group will receive intramuscular injection of botulinum toxin type A into the bulbospongiosus muscle. A total dose of 100 units of botulinum toxin type A, diluted in 10 milliliters of normal saline, will be administered under ultrasound guidance. The injection will be divided equally, with 5 milliliters injected on each side of the muscle to ensure even distribution across most muscle fibers. The procedure will be performed under aseptic conditions with patients in the lithotomy position.

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: DRUG

Botulinum toxin type A will be reconstituted by diluting 100 units in 10 milliliters of sterile normal saline. Using ultrasound guidance, 5 milliliters will be injected into each side of the bulbospongiosus muscle through a single puncture site while the patient is in the lithotomy position. The aim is to achieve even distribution of the toxin within the muscle fibers to reduce muscular contractions associated with ejaculation.

Hyaluronic Acid Injection Group

Participants in this group will receive injection of hyaluronic acid into the glans penis using the Fanning Technique. Two milliliters of 3.5 percent micronized hyaluronic acid gel will be injected through a single puncture site using a 27-gauge needle. The injection will start from the tip of the glans and proceed toward the coronal sulcus to achieve uniform distribution of the gel. The procedure will be performed under local anesthesia with application of topical lidocaine and prilocaine cream for 30 minutes prior to injection.

Group Type: EXPERIMENTAL

Hyaluronic acid

Intervention Type: DRUG

Two milliliters of 3.5 percent micronized hyaluronic acid gel will be injected into the dermis of the glans penis using the Fanning Technique. The injection will be performed through a single puncture site with a 27-gauge needle, advancing from the tip of the glans toward the coronal sulcus to distribute the gel evenly. Topical anesthetic cream containing lidocaine and prilocaine will be applied for 30 minutes before the procedure.

Interventions

Botulinum toxin type A

Botulinum toxin type A will be reconstituted by diluting 100 units in 10 milliliters of sterile normal saline. Using ultrasound guidance, 5 milliliters will be injected into each side of the bulbospongiosus muscle through a single puncture site while the patient is in the lithotomy position. The aim is to achieve even distribution of the toxin within the muscle fibers to reduce muscular contractions associated with ejaculation.

Intervention Type: DRUG

Hyaluronic acid

Two milliliters of 3.5 percent micronized hyaluronic acid gel will be injected into the dermis of the glans penis using the Fanning Technique. The injection will be performed through a single puncture site with a 27-gauge needle, advancing from the tip of the glans toward the coronal sulcus to distribute the gel evenly. Topical anesthetic cream containing lidocaine and prilocaine will be applied for 30 minutes before the procedure.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maher Wahba

Assistant Lecturer of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MD 9-5-2025

Identifier Type: -

Identifier Source: org_study_id