Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

NCT ID: NCT03459833

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-19
• Study Completion Date: 2018-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hyaluronic Acid

Intervention Type: 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 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.

Group Type: PLACEBO_COMPARATOR

Hyaluronic Acid

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Wael Ragab

Clinical demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hamed A Hamed, MD

Role: STUDY_DIRECTOR

Professor of Andrology, Cairo University

Other Identifiers

PE:HA glans augmentation

Identifier Type: -

Identifier Source: org_study_id