Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research

July 17, 2019 updated by: Baibing Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Research and Clinical Value of New Classification for Premature Ejaculation:Multi-Center Research

An observational study on the effect of new classification for premature ejaculation.

Study Overview

Status

Completed

Conditions

Detailed Description

Premature ejaculation (PE) is one of the the most common male sexual dysfunctions and it has negative impacts on people's quality of life. According to the time that PE syndromes come out, PE is clinically divided to primary PE , which appear from the first sex ,and secondary PE ,which occurred after a period of normal ejaculation. This method of classification make little sense for treatment. In 2008, PE was divided into four types: primary PE, secondary PE, natural variable PE and premature-like ejaculatory dysfunction , and different types of premature ejaculation have their corresponding treatment. Both method of classification are based on the subjective feelings of patients, then whether certain objective test can be used to help diagnosing premature ejaculation? The drug treatment of PE mainly includes local anesthetics and selective 5- serotonin reuptake inhibitor (SSRI), and the selective penile dorsal nerve block is the most used surgery. But the efficacy of dapoxetine(a new SSRI for PE) and local anesthetics is only about 60-70% and 60%, respectively, while the efficacy of surgery is not exact without a standard surgical indication. We suppose that there may be different subtypes of the nerve of patients with premature ejaculation may exist in, which corresponds to a specific treatment.

In previous study, the investigators studied the somatic sensory pathway and autonomic nerve function of patients with premature ejaculation, and found that they were characterized by different neural electrophysiological characteristics. About 60% patients with primary PE show hypersensitivity of penis, and the efficacy of local anesthetics or selective penile dorsal nerve block for them reached 90%. While SSRI can reduce the excitability of the sympathetic nervous system in patients with PE, and the effect of this drug on patients with Sympathetic hyperexcitability is better than those without Sympathetic hyperexcitability. Thus doctors here have already been dividing patients who only suffer from PE(no other diseases mentioned in exclusion criteria)into 4 groups according to the results of nerve electrophysiological examination and give corresponding treatment: 1. Penile sensory hyperexcitability Group, using local anaesthetics(compound lidocaine cream)to treat; 2. Sympathetic hyperexcitability Group: using selective serotonin reuptake inhibitor(SSRI)(Dapoxetine) to treat. 3. Mixed type Group: both Penile sensory hyperexcitability and Sympathetic hyperexcitability: Combined use of two treatments above. 4. Other Group: result of nerve electrophysiological examination is normal: this group of patients will receive further examination to figure out the reason. This pattern of treatment has been used in clinical practice for years.

In this research, the investigators will systemically observe the result of this classification and treatment for 12 weeks. Patients will be asked for participating in this research. The questionnaires(IELT,PEDT,PEP) can be filled in when visited or online about every 4 weeks. If he refused , he would still receive the classified treatment but not enrolled in this research. After treatment of 12 weeks, the investigators will measure the change of IELT, PEDT, PEP, nerve electrophysiological examination and CGIC, then compare the efficacy of the treatment to that has been reported before. If anyone do not want to continue the treatment, he could quit from this research. Software SPSS17.0 will be used for data analysis. The age, height, weight, quantity table, the latency and amplitude of each group will be expressed by the mean add or subtract standard deviation. Quantitative data comparison among groups was analyzed by single factor variance analysis (one-way ANOVA and LSD), comparison of rate using x2 test, comparison of before and after treatment compared with paired t test. P<0.05 showed statistically significant difference.

Study Type

Observational

Enrollment (Actual)

568

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Provincial Hospital of Traditional Chinese Medicine
      • Nanjing, Jiangsu, China, 210002
        • Jingling Hospital
      • Nanjing, Jiangsu, China, 210009
        • Affiliated Zhongda Hospital of Southeast University
      • Nanjing, Jiangsu, China, 210053
        • Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
      • Yangzhou, Jiangsu, China, 225001
        • Northern Jiangsu People's Hospital

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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Adult males with sympton of premature ejaculation, excepting for other diseases.

Description

Inclusion Criteria:

  1. Male aged between 18 and 60;
  2. Men in stable heterosexual, monogamous relationships >6 months;
  3. Symptom of PE: Ejaculation that always or nearly always occurs prior to or within 2 minute of vaginal penetration from the first sexual experience; the inability to delay ejaculation; and negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy.

Exclusion Criteria:

  1. Urinary system infection: Abnormal result of routine urine and prostatic fluid routine examination;
  2. Abnormal sex hormone: Abnormal result of sex hormone examination;
  3. Systemic disease: hypertension, diabetes mellitus, alcohol dependence syndrome, coronary heart disease, and Mental disorder;
  4. Organic disorder: Abnormal palpation of external genitals, testis, epididymis and spermatic cord;
  5. Drug influence: use of any drug for PE, e.g. SSRI , PDE-5, tramadol, etc;
  6. Known drug allergy to amide-type local anaesthetics or dapoxetine;
  7. Currently participating, or in the past 30 days quit a another clinical research independent with this research;
  8. Drugs, alcohol or substance abuse in last 6 months;
  9. moderate or more severe erectile Dysfunction.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group I
Penile sensory hyperexcitability: Latencies of GPSEP and/or DNSEP of them are abnormal. They will receive treatment of Compound Lidocaine Cream-a kind of local anaesthetics that is widely used to treat PE.
Group II
Sympathetic hyperexcitability: Latency of PSSR are abnormal.They will be treated with Dapoxetine(Priligy)-a kind of selective serotonin reuptake inhibitor(SSRI) which has been shown effective to PE.
Group III
Mixed type: Both Latencies of GPSEP and/or DNSEP and Latency of PSSR are abnormal.They will receive both Compound Lidocaine Cream and Dapoxetine.
Group IV
Others: Both Latencies of GPSEP, DNSEP and Latency of PSSR are normal.They will receive further tests. (This group is not the main objects to be observed in this study.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Intra-vaginal Ejaculation Latency Time（IELT）
Time Frame: After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment
Most commonly used in research on premature ejaculation.
After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment
Change of score of Premature ejaculation diagnostic tool（PEDT）
Time Frame: After enrollment,after 12 weeks' treatment
A questionnaire to evaluate and diagnose premature ejaculation
After enrollment,after 12 weeks' treatment
Change of grade Premature ejaculation profile（PEP）
Time Frame: After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment
A questionnaire consists of 4 questions to evaluate the 4 aspects of the symptom of premature ejaculation
After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment
The change of results of Nerve electrophysiological examination
Time Frame: After enrollment,after 12 weeks' treatment
To measure the penile sensory excitability and penile skin sympathetic excitability.
After enrollment,after 12 weeks' treatment
Clinical Global Impression of Change
Time Frame: After 12 weeks' treatment
A single question to measure the change after treatment
After 12 weeks' treatment
Change of Chinese Index of Premature Ejaculation of five items(CIPE-5)
Time Frame: After enrollment,after 12 weeks' treatment
A questionnaire to evaluate and diagnose premature ejaculation designed for Chinese people
After enrollment,after 12 weeks' treatment

Collaborators and Investigators

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Study Chair: Yutian Dai, Doctor, Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 30, 2017

Study Registration Dates

First Submitted

September 27, 2015

First Submitted That Met QC Criteria

October 7, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL2014001

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.

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