Lidocaine Spray
Conditions
Keywords
Premature Ejaculation
Brief summary
This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.
Detailed description
This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks. All medications were applied on the glans penis for 10-20 minutes and then cleaned before planed sexual intercourse. Patients were evaluated with Arabic Index of Premature Ejaculation (AIPE) scores, intravaginal ejaculatory latency times (IELTs), and frequency of sexual intercourse before and after treatments.
Interventions
DRUGLidocaine 5% spray
Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks (One to two applications (1-2 ml) of lidocaine 5% sprays; contain 5 -10 mg of lidocaine, in a metered dose aerosol-delivery system).
OTHERPlacebo
Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Patients were randomized evenly categorized into two treatment groups. Patient's distribution in the two groups was according to randomized encoded ballots, and they were unobservant of the type of the topical medications used.
Intervention model description
Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks (One to two applications (1-2 ml) of lidocaine 5% sprays; contain 5 -10 mg of lidocaine, in a metered dose aerosol-delivery system). Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks (One to two applications (1-2 ml) of alcohol 70% sprays).
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of lifelong premature ejaculation
Exclusion criteria
1. renal or liver diseases, 2. diabetes mellitus, 3. thyroid diseases, 4. chronic prostatitis, 5. neurological diseases 6. allergic reactions to local anesthetics or alcohols. 7. erectil dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arabic Index of Premature Ejaculation Scores | 0-8 weeks after treatment | Patients were informed to fulfill the questionnaires of Arabic Index of Premature Ejaculation (AIPE). |
| Intravaginal ejaculatory latency times | 0-8 weeks after treatment | Patients were informed to sign up intravaginal ejaculatory latency times (IELTs) using stopwatches. |
Countries
Egypt
Outcome results
None listed