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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine 5% spray | Active Comparator | 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). |
|
| Placebo | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 5% spray | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Arabic Index of Premature Ejaculation Scores | Patients were informed to fulfill the questionnaires of Arabic Index of Premature Ejaculation (AIPE). | 0-8 weeks after treatment |
| Intravaginal ejaculatory latency times | Patients were informed to sign up intravaginal ejaculatory latency times (IELTs) using stopwatches. | 0-8 weeks after treatment |
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Inclusion Criteria:
Clinical diagnosis of lifelong premature ejaculation
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Sohag University, Egypt | Sohag | 82524 | Egypt |
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| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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).
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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.
| Placebo | Other | Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks. |
|
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Aniline Compounds |
| D000588 | Amines |