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

NCT ID: NCT02572037

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 568 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-07-30

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.

Conditions

Premature Ejaculation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.)

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Baibing Yang

Resident of Nanjing Drum Tower Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yutian Dai, Doctor

Role: STUDY_CHAIR

Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Locations

Jingling Hospital

Nanjing, Jiangsu, China

Affiliated Zhongda Hospital of Southeast University

Nanjing, Jiangsu, China

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Nanjing, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Countries

China

References

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Xia JD, Zhou LH, Han YF, Chen Y, Wang R, Dai YT. A reassessment of penile sensory pathways and effects of prilocaine-lidocaine cream in primary premature ejaculation. Int J Impot Res. 2014 Sep-Oct;26(5):186-90. doi: 10.1038/ijir.2014.5. Epub 2014 Feb 27.

Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Other Identifiers

BL2014001

Identifier Type: -

Identifier Source: org_study_id