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

Chronic Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976751
• Other study ID #: 2002020080
• Status: Recruiting
• Phase: Phase 1
• Start date: May 13, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2021
• Source: Xijing Hospital
• Contact: Yuan Jianlin, doctor
• Phone: 86-029-84775321
• Email: jianliny[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: June 30, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patient meets the diagnostic criteria of National Institutes of Health (NIH)? 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.

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Chronic Prostatitis
• Pelvic Pain
• Prostatitis

Intervention

Drug:
• Percutaneous electrical nerve stimulation treatment
Using the percutaneous electrical nerve stimulation instrument to different points of the body

Locations

Country	Name	City	State
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	international prostate symptom score (IPSS)	The score improved significantly from baseline	through study completion, an average of 1 year