NCT05749614

Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation

Clinical Application of Penile Biological Vibration Threshold for Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: Male
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	Lidocaine cream	Group 1 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.
DRUG	Lidocaine cream	Group 2 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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-03-01
• Completion: 2023-04-01
• First posted: 2023-03-01
• Last updated: 2023-03-01

Locations

1 site across 1 country: China