Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

• ClinicalTrials.gov Identifier: NCT03459833
• Recruitment Status: Completed
• First Posted: March 9, 2018
• Last Update Posted: March 13, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Mohamed Wael Ragab, Cairo University

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Premature Ejaculation	Drug: Hyaluronic Acid	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Patients with premature ejaculation according to the definition of Fourth International Consultation on Sexual Medicine 2015
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation: Randomized Controlled Cross-over Trial
• Actual Study Start Date: August 19, 2016
• Actual Primary Completion Date: March 2018
• Actual Study Completion Date: March 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: group 1; 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; 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.
Placebo Comparator: group 2; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. IELT [ Time Frame: Change from baseline after one month ]
   Intra-vaginal Ejaculation Latency Time
2. AIPE [ Time Frame: Change from baseline after one month ]
   Arabic index of premature ejaculation

Secondary Outcome Measures :

1. IELT [ Time Frame: Change from baseline after three, six and nine months ]
   Intra-vaginal Ejaculation Latency Time

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Cairo University

Investigators

• Study Director: Hamed A Hamed, MD; Professor of Andrology, Cairo University

More Information

• Responsible Party: Mohamed Wael Ragab, Clinical demonstrator, Cairo University
• ClinicalTrials.gov Identifier: NCT03459833
• Other Study ID Numbers: PE:HA glans augmentation
• First Posted: March 9, 2018
• Last Update Posted: March 13, 2018
• Last Verified: March 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Wael Ragab, Cairo University:

premature ejaculation; IELT; hyaluronic acid; glans penis augmentation

Additional relevant MeSH terms:

Premature Birth; Premature Ejaculation; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Hyaluronic Acid; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Viscosupplements; Protective Agents