Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation

February 28, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
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.
Experimental: Group 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Arabic Index of Premature Ejaculation (AIPE)
Time Frame: through study completion,an average of 4 weeks
through study completion,an average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

February 19, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-9941

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Ejaculation

Clinical Trials on Lidocaine cream

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe