Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459833
• Other study ID #: PE:HA glans augmentation
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2018
• Last updated: March 10, 2018
• Start date: August 19, 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• Hyaluronic Acid
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IELT	Intra-vaginal Ejaculation Latency Time	Change from baseline after one month
Primary	AIPE	Arabic index of premature ejaculation	Change from baseline after one month
Secondary	IELT	Intra-vaginal Ejaculation Latency Time	Change from baseline after three, six and nine months