Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749614
• Other study ID #: 2022-9941
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: March 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Luopei Wei	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arabic Index of Premature Ejaculation (AIPE)		through study completion,an average of 4 weeks