Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized Study
- Conditions
- Premature Ejaculation
- Interventions
- Registration Number
- NCT07236632
- Lead Sponsor
- Benha University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botulinum Toxin Injection Group Botulinum toxin type A 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. Hyaluronic Acid Injection Group Hyaluronic acid 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
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.
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).