Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ej… (NCT07236632) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized Study
80 participantsStarted 2025-12-15
Plain-language 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.
Who can participate
Age range
22 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in intravaginal ejaculatory latency time
Timeframe: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention