Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle for Premature Eja… (NCT06851598) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle for Premature Ejaculation
Egypt45 participantsStarted 2024-07-01
Plain-language summary
The aim of this work is to assess the efficacy and safety of Botulinum toxin - A injection into ischiocavernosus muscle in treatment of primary premature ejaculation.
Who can participate
Age range16 Years – 65 Years
SexMALE
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:
* 1\. Patients with primary (lifelong) PE, with Ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration according to The International Society for Sexual Medicine (ISSM) In August 2014.
\_2. Being married for at least 4 months, and in a stable relationship with regular sexual intercourse at least twice per week with a cooperative female partner.
* 3\. Normal erectile function.
* 4\. Age 18-65 years.
Exclusion Criteria:
1\. Erectile dysfunction or other Andrological disorders e.g., Cryptorchidism, Peyronie's disease and 3rd degree varicocele. 2. Major psychiatric or psychological illness. 3. Chronic medical disorders that may limit the usage of Botulinum toxin - A such as myasthenia gravis. 4. Men receiving medications that could affect ejaculatory function e.g., Antidepressants and antihypertensive. 5. Age less than 18 or more than 65.
\-