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

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ClinicalTrials.gov Identifier: NCT02572037
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Baibing Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Condition or disease
Premature Ejaculation

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
Actual Enrollment : 584 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research and Clinical Value of New Classification for Premature Ejaculation:Multi-Center Research
Actual Study Start Date : October 2015
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 30, 2017

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.)



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.

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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult males with sympton of premature ejaculation, excepting for other diseases.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572037


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

Other Publications:
Responsible Party: Baibing Yang, Resident of Nanjing Drum Tower Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT02572037     History of Changes
Other Study ID Numbers: BL2014001
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by Baibing Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
Premature ejaculation
Dapoxetine
local anaesthetics
nerve electrophysiology

Additional relevant MeSH terms:
Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders