Premature Ejaculation
Conditions
Keywords
Hyaluronic Acid, Botulinum Toxins, Ejaculation, Glans Penis, Bulbospongiosus Muscle, Intradermal Injections, Drug Resistance
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.
Interventions
DRUGBotulinum 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.
DRUGHyaluronic 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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two-arm randomized trial comparing botulinum toxin A injection into the bulbospongiosus muscle vs hyaluronic acid injection into the glans (Fanning Technique) in lifelong drug-resistant premature ejaculation (PE).
Eligibility
Sex/Gender
MALE
Age
22 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in intravaginal ejaculatory latency time | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Premature Ejaculation Diagnostic Tool (PEDT) score | 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. |
| Change in Arabic Index of Premature Ejaculation (AIPE) score | 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. |
| Change in Premature Ejaculation Profile (PEP) score | 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. |
| Patient satisfaction score | 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). |
Outcome results
None listed