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

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572037
• Other study ID #: BL2014001
• Status: Completed
• Start date: October 2015
• Est. completion date: July 30, 2017

Study information

• Verified date: July 2019
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: July 30, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Locations

Country	Name	City	State
China	Affiliated Zhongda Hospital of Southeast University	Nanjing	Jiangsu
China	Jiangsu Provincial Hospital of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Jingling Hospital	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School	Nanjing	Jiangsu
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

References & Publications (11)

Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AW, Adaikan PG, Becher E, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An Update of the International Society of Sexual Medicine's Guidelines for the Diagnosis and Treatment of Premature Ejaculation (PE). Sex Med. 2014 Jun;2(2):60-90. doi: 10.1002/sm2.28. Review. — View Citation

Dinsmore WW, Wyllie MG. PSD502 improves ejaculatory latency, control and sexual satisfaction when applied topically 5 min before intercourse in men with premature ejaculation: results of a phase III, multicentre, double-blind, placebo-controlled study. BJ — View Citation

McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. — View Citation

McMahon CG, Althof SE, Waldinger MD, Porst H, Dean J, Sharlip ID, Adaikan PG, Becher E, Broderick GA, Buvat J, Dabees K, Giraldi A, Giuliano F, Hellstrom WJ, Incrocci L, Laan E, Meuleman E, Perelman MA, Rosen RC, Rowland DL, Segraves R. An evidence-based — View Citation

McMahon CG. Efficacy of dapoxetine in the treatment of premature ejaculation. Clin Med Insights Reprod Health. 2011 Aug 2;5:25-39. doi: 10.4137/CMRH.S7337. eCollection 2011 Aug 2. — View Citation

Serefoglu EC, McMahon CG, Waldinger MD, Althof SE, Shindel A, Adaikan G, Becher EF, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An evidence-based unified de — View Citation

Waldinger MD. Recent advances in the classification, neurobiology and treatment of premature ejaculation. Adv Psychosom Med. 2008;29:50-69. doi: 10.1159/000126624. Review. — View Citation

Waldinger MD. The neurobiological approach to premature ejaculation. J Urol. 2002 Dec;168(6):2359-67. Review. — View Citation

Xia J, Chen T, Chen J, Han Y, Xu Z, Zhou L, Chen Y, Dai Y. The sympathetic skin response located in the penis as a predictor of the response to sertraline treatment in patients with primary premature ejaculation. J Sex Med. 2014 Nov;11(11):2801-8. doi: 10 — View Citation

Xia JD, Han YF, Zhou LH, Xu ZP, Chen Y, Dai YT. Sympathetic skin response in patients with primary premature ejaculation. Int J Impot Res. 2014 Jan;26(1):31-4. doi: 10.1038/ijir.2013.23. Epub 2013 May 2. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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