Clinical trial NCT02572037: Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research
Official title: Research and Clinical Value of New Classification for Premature Ejaculation:Multi-Center Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Ejaculation
Keywords: Premature ejaculation
Dapoxetine
local anaesthetics
nerve electrophysiology
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 568
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult males with sympton of premature ejaculation, excepting for other diseases.

Brief summary: An observational study on the effect of new classification for 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.

Eligibility 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.

Primary outcomes:
measure: Change of Intra-vaginal Ejaculation Latency Time（IELT）
timeFrame: After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment
measure: Change of score of Premature ejaculation diagnostic tool（PEDT）
timeFrame: After enrollment,after 12 weeks' treatment
measure: Change of grade Premature ejaculation profile（PEP）
timeFrame: After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment
measure: The change of results of Nerve electrophysiological examination
timeFrame: After enrollment,after 12 weeks' treatment
measure: Clinical Global Impression of Change
timeFrame: After 12 weeks' treatment
measure: Change of Chinese Index of Premature Ejaculation of five items(CIPE-5)
timeFrame: After enrollment,after 12 weeks' treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jingling Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Affiliated Zhongda Hospital of Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
name: Yutian Dai, Doctor
role: STUDY_CHAIR
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