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Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

Primary Purpose

Premature Ejaculation

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hyaluronic Acid
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring premature ejaculation, IELT, hyaluronic acid, glans penis augmentation

Eligibility Criteria

20 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    group 1

    group 2

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    IELT
    Intra-vaginal Ejaculation Latency Time
    AIPE
    Arabic index of premature ejaculation

    Secondary Outcome Measures

    IELT
    Intra-vaginal Ejaculation Latency Time

    Full Information

    First Posted
    February 12, 2018
    Last Updated
    March 10, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03459833
    Brief Title
    Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation
    Official Title
    Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation: Randomized Controlled Cross-over Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 19, 2016 (Actual)
    Primary Completion Date
    March 2018 (Actual)
    Study Completion Date
    March 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ejaculation
    Keywords
    premature ejaculation, IELT, hyaluronic acid, glans penis augmentation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Model Description
    Patients with premature ejaculation according to the definition of Fourth International Consultation on Sexual Medicine 2015
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group 1
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    group 2
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronic Acid
    Intervention Description
    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 Measure Information:
    Title
    IELT
    Description
    Intra-vaginal Ejaculation Latency Time
    Time Frame
    Change from baseline after one month
    Title
    AIPE
    Description
    Arabic index of premature ejaculation
    Time Frame
    Change from baseline after one month
    Secondary Outcome Measure Information:
    Title
    IELT
    Description
    Intra-vaginal Ejaculation Latency Time
    Time Frame
    Change from baseline after three, six and nine months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamed A Hamed, MD
    Organizational Affiliation
    Professor of Andrology, Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

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