Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

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 .

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Key information

Conditions

Premature Ejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid

Drug

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.

Primary outcomes

IELT

Time frame: Change from baseline after one month

Intra-vaginal Ejaculation Latency Time
AIPE

Time frame: Change from baseline after one month

Arabic index of premature ejaculation

Secondary outcomes

IELT

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

Intra-vaginal Ejaculation Latency Time

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation: Randomized Controlled Cross-over Trial

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Mar 9, 2018
Registry last updated: Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed