Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation

Last updated: February 28, 2023
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Premature Ejaculation

Treatment

N/A

Clinical Study ID

NCT05749614
2022-9941
  • Ages 19-60
  • Male

Study Summary

This study aimed to evaluate the efficacy and safety of applying 5% lidocaine cream to the sensitive area of the glans penis after its precise localization under the penile biological vibration threshold test for the treatment of primary premature ejaculation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult male (19-60 years old); stable partner for ≥3 months; Premature EjaculationDiagnostic Tool (PEDT) score ≥ 11; penile biological vibration threshold testsuggesting the presence of sensitive sites on the glans penis (vibration threshold < 30 levels); no history of long-term use of specific medications; normal sex hormonelevels; and no genital or secondary ejaculation. There was no history of long-term useof specific drugs, normal sex hormone levels, and genital or secondary sexualcharacteristics abnormalities.

Exclusion

Exclusion Criteria:

  • (1) those with abnormal or malformed genital development; (2) those with allergicreactions to local anesthetics; (3) those who had been treated with central nervoussystem drugs or PE in the last 3 months; (4) those with a history of long-term alcoholabuse and trauma such as neurological and pelvic fractures; (5) those with long-termuse of hypotensive drugs, diuretics, and sedative drugs (6) patients with a history ofprevious surgery and trauma to the reproductive system; (7) patients with PE due tohypogonadism, thyroid disease, and abnormal lipid metabolism.

Study Design

Total Participants: 80
Study Start date:
March 01, 2022
Estimated Completion Date:
April 01, 2023

Study Description

This study was a randomized, single-blind clinical controlled trial. Eighty patients diagnosed with primary premature ejaculation in an outpatient setting were included in this study. They were randomly scored into two groups. Group 1 (n = 40) was given 1 ml of 5% lidocaine cream on demand. They were instructed to apply the lidocaine cream evenly in a circular pattern to the glans penis without precise application to the sensitive area of the glans penis. The treatment lasted for a total of 4 weeks. Group 2 (n = 40) had a penile biological vibration threshold test performed to detect loci with a lower threshold. They were instructed to apply 1 ml of 5% lidocaine cream to the sensitive loci on the glans penis for 4 weeks. Lidocaine cream was applied topically or uniformly to the glans penis 20 minutes before planned intercourse in both groups and washed off 10 minutes after application. Using intravaginal ejaculation before and after treatment latency, the Arabic Index of Premature Ejaculation, Premature Ejaculation Diagnostic Tool, and the International Index of Erectile Function Scale scores were combined to assess the efficacy and side effects before and after treatment.

Connect with a study center

  • Luopei Wei

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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