Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

NCT03459833 | Completed Phase 3 DMC

• 1 other identifier: PE:HA glans augmentation
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Premature Ejaculation

Keywords

premature ejaculation; IELT; hyaluronic acid; glans penis augmentation

Outcome Measures

Primary Outcomes (2)

• IELT

  Intra-vaginal Ejaculation Latency Time

  Change from baseline after one month

• AIPE

  Arabic index of premature ejaculation

  Change from baseline after one month

Secondary Outcomes (1)

• IELT

  Change from baseline after three, six and nine months

Study Arms (2)

group 1

EXPERIMENTAL

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.

Drug: Hyaluronic Acid

group 2

PLACEBO COMPARATOR

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.

Drug: Hyaluronic Acid

Interventions

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.

group 1; group 2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Erectile dysfunction
• Hypo or hyperthyroidism
• Hypogonadism
• Hyperprolactinemia
• Drug abuse
• Psychiatric disorders or related medications

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Hamed A Hamed, MD

  Professor of Andrology, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical demonstrator

Model Details: Patients with premature ejaculation according to the definition of Fourth International Consultation on Sexual Medicine 2015

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 9, 2018
• Study Start: August 19, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03