Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

Cairo University30 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Premature Ejaculation

Interventions

Hyaluronic AcidDRUG

Glans penis augmentation using multiple puncture technique as described by Abdallah et al. (2012) with minor modifications. HA is injected at two circular levels: one at the level of corona of glans penis and a second circular level is mid-way between the corona and urethral meatus. Six injections are injected at coronal level and four are injected in the second level, each injection is of 0.2 ml and is injected into deep dermis.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

IELT

Intra-vaginal Ejaculation Latency Time

Time frame: Change from baseline after one month

AIPE

Arabic index of premature ejaculation

Time frame: Change from baseline after one month

Secondary Outcomes

IELT

Intra-vaginal Ejaculation Latency Time

Time frame: Change from baseline after three, six and nine months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.