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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Change in intravaginal ejaculatory latency time [Срок оценки: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention]

Вторичные конечные точки (4)

• Change in Premature Ejaculation Diagnostic Tool (PEDT) score [Срок оценки: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention]
• Change in Arabic Index of Premature Ejaculation (AIPE) score [Срок оценки: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention]
• Change in Premature Ejaculation Profile (PEP) score [Срок оценки: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention]
• Patient satisfaction score [Срок оценки: 1 month, 3 months, 6 months, and 12 months after intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07236632 · MD 9-5-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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