Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

Study Overview
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Brief Summary
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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 .

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

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Drug: Hyaluronic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients with premature ejaculation according to the definition of Fourth International Consultation on Sexual Medicine 2015
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>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<br>* 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.<br>|
| Placebo Comparator: group 2<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IELT | Intra-vaginal Ejaculation Latency Time | Change from baseline after three, six and nine months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature ejaculation, IELT, hyaluronic acid, glans penis augmentation