Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation
Premature Ejaculation
About this trial
This is an interventional treatment trial for Premature Ejaculation focused on measuring premature ejaculation, IELT, hyaluronic acid, glans penis augmentation
Eligibility Criteria
Inclusion Criteria:
- occurrence of ejaculation in patients with lifelong premature ejaculation (LL PE) within 1 minute form vaginal penetration in all or almost all occasions starting from the first sexual experience, and within 3 minutes in patients with acquired premature ejaculation (A PE), along with inability to delay ejaculation on all or nearly all vaginal penetrations, with negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy
Exclusion Criteria:
- Erectile dysfunction
- Hypo or hyperthyroidism
- Hypogonadism
- Hyperprolactinemia
- Drug abuse
- Psychiatric disorders or related medications
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
group 1
group 2
15 patients They will receive a topical anesthetic agent for 30 minutes (Emla cream; lidocaine 25 mg, prilocaine 25 mg, Astra Xeneca, Mississauga, Canada) followed by injection of two prefilled 1 ml syringes with 30 G needle of hyaluronic acid (HA; Teosyal® PureSense Global Action, Teoxane Laboratories, Geneva, Switzerland). After 18 months from the HA injection, cross-over to placebo arm will be done.
They receive by the same method 2 ml saline as a placebo. After one month of the injection, cross-over to HA arm will be done.