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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04976751
Enrollment
274
Registered
2021-07-26
Start date
2021-05-13
Completion date
2023-06-30
Last updated
2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pelvic Pain, Chronic Prostatitis

Keywords

transcutaneous electric nerve stimulation, andrology

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.

Interventions

DRUGPercutaneous electrical nerve stimulation treatment

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

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI)through study completion, an average of 1 yearImprovement 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

MeasureTime frameDescription
international prostate symptom score (IPSS)through study completion, an average of 1 yearThe score improved significantly from baseline

Countries

China

Contacts

Primary ContactYuan Jianlin, doctor
jianliny@fmmu.edu.cn86-029-84775321
Backup ContactLu Jun, master
lujun901101@sina.com86-029-84775321

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026