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NCT Number: NCT07236632

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

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.

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Key information

Conditions

Premature Ejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

22 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Botulinum Toxin Type A

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

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.

Primary outcomes

  1. Change in intravaginal ejaculatory latency time

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention

    The duration from vaginal penetration to ejaculation will be recorded using a stopwatch by the patient's partner. The median intravaginal ejaculatory latency time will be calculated for each participant from several intercourse attempts. The change in latency time after treatment compared with baseline will be used to assess treatment efficacy.

Secondary outcomes

  1. Change in Premature Ejaculation Diagnostic Tool (PEDT) score

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention

    The Premature Ejaculation Diagnostic Tool questionnaire will be used to evaluate changes in ejaculatory control and distress levels. Higher scores indicate greater severity.

  2. Change in Arabic Index of Premature Ejaculation (AIPE) score

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention

    The Arabic Index of Premature Ejaculation questionnaire will assess subjective improvement in control, satisfaction, and distress related to ejaculation. Higher scores reflect better control and lower distress.

  3. Change in Premature Ejaculation Profile (PEP) score

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention

    The Premature Ejaculation Profile will be used to evaluate treatment-related improvement across four domains: perceived control, personal distress, interpersonal difficulty, and sexual satisfaction.

  4. Patient satisfaction score

    Time frame: 1 month, 3 months, 6 months, and 12 months after intervention

    Participants will rate overall satisfaction with the procedure using a four-point scale (0 = dissatisfied, 1 = slightly satisfied, 2 = satisfied, 3 = very satisfied).

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

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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