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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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

Detailed Summary:

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 t
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Current Primary Outcome:

  • 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.
  • 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
  • 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
  • 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.
  • Clinical Global Impression of Change [ Time Frame: After 12 weeks' treatment ]
    A single question to measure the change after 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

    • Original Primary Outcome:

    • 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.
    • Change of score of Premature ejaculation diagnostic tool（PEDT） [ Time Frame: After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment ]
      A questionnaire to evaluate and diagnose premature ejaculation
    • 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
    • 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.
    • Clinical Global Impression of Change [ Time Frame: After 12 weeks' treatment ]
      A single question to measure the change after treatment


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Dates:
    Date Received: September 27, 2015
    Date Started: October 2015
    Date Completion: July 2017
    Last Updated: March 27, 2017
    Last Verified: March 2017