Clinical trial NCT06172855: The Study on the Effectiveness and Safety of Electroacupuncture at ST36 in Treating Primary Premature Ejaculation
Official title: The Study on the Effectiveness and Safety of Electroacupuncture at ST36 (Zusanli) in Treating Primary Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Ejaculation
Keywords: Premature Ejaculation
Electroacupuncture
ST36
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot prospective single-arm cohort study on the Effectiveness and Safety of Electroacupuncture at ST36(Zusanli) in Treating Primary Premature Ejaculation

Detailed description: This is a pilot prospective single-arm cohort study to verify the Effectiveness and Safety of Electroacupuncture at ST36(Zusanli) in Treating Primary Premature Ejaculation, based on the result on animal study that daily electroacupuncture at ST36(Zusanli) for 30 days could delay the ejaculation of male SD rats.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 60
2. Heterosexual, with a single, stable partner for more than 6 months
3. Symptoms of primary premature ejaculation: Complaints of IELT ≤ 1 min since the first sexual intercourse, and poor ability to control ejaculation leading to anxiety, annoyance, depression or/and avoidance of sexual life and other negative effects.

Exclusion Criteria:

1. Urinary system infection: Urinary tract infection symptoms (such as urinary tract irritation symptoms, prostatitis symptoms, blood semen, etc.) or urine routine shows abnormal white blood cells and red blood cells
2. Abnormal androgen: sex hormone examination shows abnormal androgen (testosterone)
3. Systemic diseases: ask about medical history of hypertension, diabetes, alcohol dependence, coronary heart disease and mental disorders
4. Organic abnormalities: Abnormal development of external genitalia, bilateral testes, epididymis and spermatic cords with obvious abnormalities on palpation
5. History of surgery and trauma: Dorsal nerve block of the penis, erectile function-related surgery, prostate surgery, pelvic surgery, etc.
6. Influence of drugs: within one month before enrollment, have taken SSRI, tramadol and other drugs to treat diseases
7. Allergy to dapoxetine and lidocaine
8. History of drug, alcohol or substance abuse in the past 6 months
9. Accompanied by erectile dysfunction: International Index of Erectile Function-5 (International Index of Erectile Function, IIEF-5) score ≤ 21 points

Primary outcomes:
measure: Change from baseline intravaginal ejaculatory latency time
timeFrame: Week 6, 10, 14, 18
Secondary outcomes:
measure: Premature Ejaculation Diagnose Tool
timeFrame: Week 0, 6, 10, 14, 18
measure: Premature Ejaculation Profile
timeFrame: Week 0, 6, 10, 14, 18
measure: Chinese Index of Premature Ejaculation
timeFrame: Week 0, 6, 10, 14, 18
measure: Penile Nerve Electrophysiology
timeFrame: Week 0, 6, 18
measure: Clinical Global Impression of Change
timeFrame: Week 6, 18
measure: fMRI
timeFrame: Week 0, 6
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
name: Baibing Yang, Doctor
role: STUDY_CHAIR
References:
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 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.
citation: Kimura K, Kitagawa Y, Tajima F. Effects of a Single Session of Acupuncture Treatment on Blood Pressure and Heart Rate Variability in Patients with Mild Hypertension. J Altern Complement Med. 2021 Apr;27(4):342-348. doi: 10.1089/acm.2020.0324. Epub 2021 Jan 28.
citation: Xia JD, Chen J, Yang BB, Sun HJ, Zhu GQ, Dai YT, Yang J, Wang ZJ. Differences in sympathetic nervous system activity and NMDA receptor levels within the hypothalamic paraventricular nucleus in rats with differential ejaculatory behavior. Asian J Androl. 2018 Jul-Aug;20(4):355-359. doi: 10.4103/aja.aja_4_18.
citation: Zhang QJ, Yang BB, Yang J, Wang YM, Dai YT, Song NH, Wang ZJ, Xia JD. Inhibitory Role of Gamma-Aminobutyric Receptors in Paraventricular Nucleus on Ejaculatory Responses in Rats. J Sex Med. 2020 Apr;17(4):614-622. doi: 10.1016/j.jsxm.2020.01.006. Epub 2020 Feb 7.
citation: Liu S, Wang ZF, Su YS, Ray RS, Jing XH, Wang YQ, Ma Q. Somatotopic Organization and Intensity Dependence in Driving Distinct NPY-Expressing Sympathetic Pathways by Electroacupuncture. Neuron. 2020 Nov 11;108(3):436-450.e7. doi: 10.1016/j.neuron.2020.07.015. Epub 2020 Aug 12.
citation: Sahin S, Bicer M, Yenice MG, Seker KG, Yavuzsan AH, Tugcu V. A Prospective Randomized Controlled Study to Compare Acupuncture and Dapoxetine for the Treatment of Premature Ejaculation. Urol Int. 2016;97(1):104-11. doi: 10.1159/000445253. Epub 2016 Apr 7.
citation: Lu MJ, Yu Z, He Y, Yin Y, Xu B. Electroacupuncture at ST36 modulates gastric motility via vagovagal and sympathetic reflexes in rats. World J Gastroenterol. 2019 May 21;25(19):2315-2326. doi: 10.3748/wjg.v25.i19.2315.