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

NCT02572037 | Completed DMC

• 1 other identifier: BL2014001
• Study Type: observational
• Target: 568
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Premature Ejaculation

Keywords

Premature ejaculation; Dapoxetine; local anaesthetics; nerve electrophysiology

Outcome Measures

Primary Outcomes (6)

• 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

• Change of score of Premature ejaculation diagnostic tool（PEDT）

  A questionnaire to evaluate and diagnose premature ejaculation

  After enrollment,after 12 weeks' treatment

• 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

• 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

• Clinical Global Impression of Change

  A single question to measure the change after treatment

  After 12 weeks' treatment

• 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

Study Arms (4)

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.)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adult males with sympton of premature ejaculation, excepting for other diseases.

You may qualify if:

• Male aged between 18 and 60;
• Men in stable heterosexual, monogamous relationships \>6 months;
• 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.

You may not qualify if:

• Urinary system infection: Abnormal result of routine urine and prostatic fluid routine examination;
• Abnormal sex hormone: Abnormal result of sex hormone examination;
• Systemic disease: hypertension, diabetes mellitus, alcohol dependence syndrome, coronary heart disease, and Mental disorder;
• Organic disorder: Abnormal palpation of external genitals, testis, epididymis and spermatic cord;
• Drug influence: use of any drug for PE, e.g. SSRI , PDE-5, tramadol, etc;
• Known drug allergy to amide-type local anaesthetics or dapoxetine;
• Currently participating, or in the past 30 days quit a another clinical research independent with this research;
• Drugs, alcohol or substance abuse in last 6 months;
• moderate or more severe erectile Dysfunction.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (6)

Jingling Hospital

Nanjing, Jiangsu, 210002, China

Location

Affiliated Zhongda Hospital of Southeast University

Nanjing, Jiangsu, 210009, China

Location

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, 210029, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Nanjing, Jiangsu, 210053, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Related Publications (11)

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

  PMID: 18391557 BACKGROUND

• Waldinger MD. The neurobiological approach to premature ejaculation. J Urol. 2002 Dec;168(6):2359-67. doi: 10.1016/S0022-5347(05)64146-8.

  PMID: 12441918 BACKGROUND

• 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.

  PMID: 25356302 BACKGROUND

• 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 definition of lifelong and acquired premature ejaculation: report of the second international society for sexual medicine ad hoc committee for the definition of premature ejaculation. Sex Med. 2014 Jun;2(2):41-59. doi: 10.1002/sm2.27.

  PMID: 25356301 RESULT

• 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 definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine (ISSM) ad hoc committee for the definition of premature ejaculation. J Sex Med. 2008 Jul;5(7):1590-606. doi: 10.1111/j.1743-6109.2008.00901.x.

  PMID: 18466262 RESULT

• 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. BJU Int. 2009 Apr;103(7):940-9. doi: 10.1111/j.1464-410X.2009.08456.x. Epub 2009 Feb 23.

  PMID: 19245438 RESULT

• 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.

  PMID: 24453509 RESULT

• 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. 2011 Feb;8(2):524-39. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 Nov 8.

  PMID: 21059176 RESULT

• 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.

  PMID: 24572995 RESULT

• 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.

  PMID: 23636274 RESULT

• 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: 10.1111/jsm.12654. Epub 2014 Aug 8.

  PMID: 25130949 RESULT

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Yutian Dai, Doctor

  Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Nanjing Drum Tower Hospital

Study Record Dates

• First Submitted: September 27, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 30, 2017
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

CN (6)