CClinicalTrials.gg
Status unknownNCT04976751Updated Jul 26, 2021

Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China

A Phase 1 interventional study of Percutaneous electrical nerve stimulation treatment in Chronic Pelvic Pain and Chronic Prostatitis, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-07-26.

Sponsored by Xijing Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
274
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

To carry out real world research on the application of electrophysiology and other suitable technologies in the prevention and treatment of male diseases in medical institutions at all levels in Northwest China, and establish a database for the prevention and treatment of male diseases in Northwest China, so as to provide a basis for the formulation of guidelines or consensus on the application of electrophysiology for the prevention and treatment of male diseases in China.

02

Conditions studied

  • Chronic Pelvic Pain
  • Chronic Prostatitis

Keywords

  • transcutaneous electric nerve stimulation
  • andrology
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Patient meets the diagnostic criteria of National Institutes of Health (NIH)Ⅲ type prostatitis;
  • NIH-CPSI score > 10;
  • The symptoms lasted for more than 3 months and failed to respond to drug treatment for more than 1 month;
  • Age ≥18 years old and ≤60 years old agrees and signs the informed consent;
  • Those who did not receive other similar treatment regimens during treatment.

Exclusion criteria

Exclusion Criteria:

  • All kinds of bacterial infection caused by acute or chronic orchitis or epididymitis, acute or chronic prostatitis, lower urinary tract infection;
  • Benign prostatic hyperplasia, prostate cancer, neurogenic bladder, urethral malformation or stricture and severe neurosis;
  • For patients with local pain as the main manifestation, attention should be paid to the exclusion of other lesions in the lower abdomen, perineum, lsosacral sites, such as ureteral calculi, bladder calculi, inguinal hernia, pubis, varicocele, epididymitis, rectocolic diseases, lsodorsal myofascitis, etc.;
  • Complicated with heart, brain, liver and hematopoietic system and other serious primary diseases, local skin infection or skin lesions in the treatment site;
  • People who have metal implants in their bodies cannot cooperate, such as patients with mental illness.
  • People who are allergic to the treatment of electrical stimulation or allergic to a variety of drugs.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
274 participants (estimated)

Study arms

  • Experimental
    Electrophysiological treatment group

    Two electrodes covered the two acupoints of Zhongliao and Huiyang, one electrode covered the three acupoints of Zhongji, Guanyuan and Qihai, and two skin paste electrodes covered the three acupoints of Sanyinjiao, and connected the electric stimulation therapy instrument for 30 minutes. The intensity was based on the patient's tolerance. 4 weeks before the course of treatment, the treatment was performed once a day, 3 times a week.In the last 4 weeks, 20 times were performed twice a week.Fluoroquinolones and alpha blockers were administered according to the patient's symptoms.

    Drug: Percutaneous electrical nerve stimulation treatment

  • No intervention
    Regular treatment group

    Fluoroquinolones and alpha blockers were administered according to the patient's symptoms.

Interventions

  • DrugPercutaneous electrical nerve stimulation treatment

    Using the percutaneous electrical nerve stimulation instrument to different points of the body

05

What researchers measure

Primary outcomes

  1. National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI)

    Improvement rate = \[(score before treatment - score at the end of treatment)/score before treatment\] ×100% The improvement rate ≥75% was considered to be significant.The improvement rate \< 75% and ≥50% were considered to be better. The improvement rate \< 50% and ≥25% were considered as average efficacy.The improvement rate \< 25% indicates poor efficacy.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. international prostate symptom score (IPSS)

    The score improved significantly from baseline

    Time frame: through study completion, an average of 1 year

06

Study locations

1 of 1 sites recruiting
  • Xijing Hospital, Fourth Military Medical University
    Xi'an, Shaanxi 710032, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — To carry out real world research on the application of electrophysiology and other suitable technologies in the prevention and treatment of male diseases in medical institutions at all levels in Northwest China, and establish a database for the prevention and treatment of male diseases in Northwest China, so as to provide a basis for the formulation of guidelines or consensus on the application of electrophysiology for the prevention and treatment of male diseases in China.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04976751
Lead sponsor
Xijing Hospital
Responsible party
Yuan Jianlin-1 (professor, Xijing Hospital) — Principal investigator
First posted
Jul 26, 2021
Start date
May 13, 2021
Primary completion
May 1, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Jul 26, 2021

Study contacts

Yuan Jianlin, doctor
Contact
jianliny@fmmu.edu.cn
86-029-84775321
Lu Jun, master
Contact
lujun901101@sina.com
86-029-84775321

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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