Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Premature Ejaculation

Treatments: Drug: Hyaluronic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03459833

PE:HA glans augmentation

Details and patient eligibility

About

This randomized controlled cross-over study aims to evaluate the effect and safety of glans penis augmentation using Hyaluronic acid in the treatment of premature ejaculation in compare with placebo .

Enrollment: 30 patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

group 1

Experimental group

Description:

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.

Treatment:

Drug: Hyaluronic Acid

group 2

Placebo Comparator group

Description:

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.

Treatment:

Drug: Hyaluronic Acid