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

NCT04976751 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 2002020080
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pelvic Pain; Chronic Prostatitis

Keywords

transcutaneous electric nerve stimulation; andrology

Outcome Measures

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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• international prostate symptom score (IPSS)

  through study completion, an average of 1 year

Study Arms (2)

Electrophysiological treatment group

EXPERIMENTAL

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

Regular treatment group

NO INTERVENTION

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

Interventions

Percutaneous electrical nerve stimulation treatment DRUG

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

Electrophysiological treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: ≥18 years old and ≤60 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Central Study Contacts

Yuan Jianlin, doctor

CONTACT

86-029-84775321; jianliny@fmmu.edu.cn

Lu Jun, master

CONTACT

86-029-84775321; lujun901101@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 26, 2021
• Study Start: May 13, 2021
• Primary Completion: May 1, 2023
• Study Completion: June 30, 2023
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)