Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

Phase 3

Completed

• Conditions: Premature Ejaculation
• Interventions: Drug: Hyaluronic Acid

• Registration Number: NCT03459833
• Lead Sponsor: Cairo University

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-19
• Study First Submitted: 2018-02-12
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Study First Submitted QC: 2018-03-03
• Study First Posted: 2018-03-09
• Last Update Submitted: 2018-03-10
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group 1	Hyaluronic Acid	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.
group 2	Hyaluronic Acid	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.

Primary Outcome Measures

Name	Time	Method
IELT	Change from baseline after one month	Intra-vaginal Ejaculation Latency Time
AIPE	Change from baseline after one month	Arabic index of premature ejaculation

Secondary Outcome Measures

Name	Time	Method
IELT	Change from baseline after three, six and nine months	Intra-vaginal Ejaculation Latency Time