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
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.
375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.
This study's planned enrollment of 274 is above the median of 60 across 277 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Fluoroquinolones and alpha blockers were administered according to the patient's symptoms.
Using the percutaneous electrical nerve stimulation instrument to different points of the body
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
international prostate symptom score (IPSS)
The score improved significantly from baseline
Time frame: through study completion, an average of 1 year
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.
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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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