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

NCT ID: NCT06172855

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Premature Ejaculation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Premature ejaculation

Adult male with primary premature ejaculation. They will receive electroacupuncture at ST36 to treat premature ejaculation.

Group Type EXPERIMENTAL

Electroacupuncture at ST36

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Baibing Yang, Doctor

Role: STUDY_CHAIR

Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Locations

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Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Baibing Yang, Doctor

Role: CONTACT

+86 13914721216

Ning Wu, Doctor

Role: CONTACT

+86 13770803612

Facility Contacts

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Baibing Yang, PhD

Role: primary

+86 13914721216

References

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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.

Reference Type BACKGROUND
PMID: 25356301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33512256 (View on PubMed)

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.

Reference Type RESULT
PMID: 29516873 (View on PubMed)

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.

Reference Type RESULT
PMID: 32037229 (View on PubMed)

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.

Reference Type RESULT
PMID: 32791039 (View on PubMed)

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.

Reference Type RESULT
PMID: 27049323 (View on PubMed)

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.

Reference Type RESULT
PMID: 31148903 (View on PubMed)

Other Identifiers

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2022-LCYJ-PY-26

Identifier Type: -

Identifier Source: org_study_id

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