The Study on the Effectiveness and Safety of Electroacupuncture at ST36 in Treating Primary Premature Ejaculation

Premature Ejaculation Clinical Trial

Official title:

The Study on the Effectiveness and Safety of Electroacupuncture at ST36 (Zusanli) in Treating Primary Premature Ejaculation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172855
• Other study ID #: 2022-LCYJ-PY-26
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Baibing Yang, Doctor
• Phone: +86 13914721216
• Email: njusupermario[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Device:
• Electroacupuncture at ST36
Electroacupuncture at ST36, which located at the anterior aspect of the lower leg, 3 cun below ST 35, one finger-breadth (middle finger) from the anterior crest of the tibia. Twice or 3 times per week, for 6 weeks.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School	Nanjing	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 (7)

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. — View 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.2020.07.01 — View 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. — View 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. — 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 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. — View 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. 2 — View 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 202 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline intravaginal ejaculatory latency time	IELT	Week 6, 10, 14, 18
Secondary	Premature Ejaculation Diagnose Tool	The premature ejaculation diagnostic tool (PEDT) is a brief diagnostic measure to assess premature ejaculation	Week 0, 6, 10, 14, 18
Secondary	Premature Ejaculation Profile	Premature Ejaculation Profile (PEP) is a self-reported outcome instrument for evaluating domains of PE and its treatment and comprises of four single-item measures, a profile, and an index score.	Week 0, 6, 10, 14, 18
Secondary	Chinese Index of Premature Ejaculation	The Chinese Index of Premature Ejaculation(CIPE) has 10 questions, focusing on libido, erectile function, ejaculatory latency, sexual satisfaction and difficulty in delaying ejaculation, self-confidence and depression. Each question was responded to on a 5 point Likert-type scale.	Week 0, 6, 10, 14, 18
Secondary	Penile Nerve Electrophysiology	An electrophysiological technique used to examine the axonal composition and reflex activity of the penile nerve	Week 0, 6, 18
Secondary	Clinical Global Impression of Change	Clinical Global Impressions (CGI) scale is a well-established research rating tool applicable to all psychiatric disorders that can easily be used by the practicing clinician to meet this need.	Week 6, 18
Secondary	fMRI	Measure GABA levels in thalamic regions using GABA spectroscopy	Week 0, 6