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

Sponsor
Xijing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04976751
Collaborator
(none)
274
1
2
25.6
10.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Percutaneous electrical nerve stimulation treatment
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
274 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
Actual Study Start Date :
May 13, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Using the percutaneous electrical nerve stimulation instrument to different points of the body

No Intervention: Regular treatment group

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

Outcome Measures

Primary Outcome Measures

  1. National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI) [through study completion, an average of 1 year]

    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.

Secondary Outcome Measures

  1. international prostate symptom score (IPSS) [through study completion, an average of 1 year]

    The score improved significantly from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xijing Hospital, Fourth Military Medical University Xi'an Shaanxi China 710032

Sponsors and Collaborators

  • Xijing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yuan Jianlin-1, professor, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT04976751
Other Study ID Numbers:
  • 2002020080
First Posted:
Jul 26, 2021
Last Update Posted:
Jul 26, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Yuan Jianlin-1, professor, Xijing Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2021