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Trial record 1 of 1 for:    "Premature Ejaculation" | "Hyaluronic acid"
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Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

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

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

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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

Resource links provided by the National Library of Medicine


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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459833


Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Hamed A Hamed, MD Professor of Andrology, Cairo University

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

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