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Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation

Primary Purpose

Premature Ejaculation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lidocaine cream
Lidocaine cream
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring Primary premature ejaculation; Lidocaine; Arabic Index of Premature Ejaculation

Eligibility Criteria

19 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Luopei WeiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Outcomes

Primary Outcome Measures

Arabic Index of Premature Ejaculation (AIPE)

Secondary Outcome Measures

Full Information

First Posted
February 19, 2023
Last Updated
February 28, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05749614
Brief Title
Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation
Official Title
Clinical Application of Penile Biological Vibration Threshold for Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
Primary premature ejaculation; Lidocaine; Arabic Index of Premature Ejaculation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lidocaine cream
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
Arabic Index of Premature Ejaculation (AIPE)
Time Frame
through study completion,an average of 4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Luopei Wei
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Zexin
Phone
+86 0571 87783759
Email
keyanlunli_zheer@163.com

12. IPD Sharing Statement

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Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation

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