None listed
Conditions
Interventions
Medical Device : Subjects who voluntarily signed the informed consent form were evaluated in person to determine whether they met the inclusion/exclusion criteria, and only eligible subjects were rand
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men = 19 years of age and < 75 years of age 2) Diagnosed with chronic prostatitis/chronic pelvic pain syndrome (NIH-CPPS IIIA or IIIB) with symptoms lasting 3 months or more within 6 months of screening 3) NIH-CPSI total score of 15 or greater 4) Agree to participate in this study and complete a written informed consent form prior to the start of the study.
Exclusion criteria
Exclusion criteria: Patients with inflammatory bowel diseases (Crohn's disease or ulcerative colitis, patients with irritable bowel syndrome) Individuals with a history of central nervous system diseases or neurological disorders affecting the bladder, voluntary urination ability, or peripheral nervous system disorders contributing to direct lower urinary tract symptoms (e.g., multiple sclerosis, autonomic neuropathy, isolated symptoms such as unilateral testicular or perineal pain, etc.) Individuals with severe heart disease, cardiac arrhythmias, wearers of cardiac assist devices, orthopedic metal implants, urinary prostheses (urethral prostheses), and other medical devices involving the insertion into the human body Individuals with a history of urological malignancies (pelvic cancer, prostate cancer, penile cancer, testicular cancer, bladder cancer, urethral cancer, etc.) PSA = 4 ng/mL at screening Individuals with a history of acute prostatitis at screening Individuals with a history of urinary tract infections (urethritis, cystitis, etc.) within the last 6 months at screening or diagnosed with conditions such as overactive bladder, calcified nodules, urinary stones, and congenital malformations contributing to lower urinary tract symptoms Individuals with a history of alcohol or drug abuse Individuals with suspected benign prostatic hyperplasia based on screening at baseline Individuals who have undergone surgery for urethral stricture or prostate enlargement or have had procedures such as prostatectomy, TURP, TUIP, TUMT, TUNA, or prostate biopsy (except for those eligible for registration after a washout period of 3 months from the date of prostate biopsy) Individuals who have undergone prostate surgery within 3 months at screening Individuals with blood coagulation disorders or those taking anticoagulants at screening Individuals who have taken the following medications at screening or require continuous administration (however, eligible for registration if there has been no administration within the specified period or a prolonged period equivalent to more than 5 half-lives before screening): ? Within the last 6 months: 5-ARIs (Dutasteride, Finasteride), or antiandrogen drugs ? Within the last 4 weeks: Antibiotics (Nitrofurantoin, Ciprofloxacin, etc.) ? Within the last 4 weeks: Alpha-blockers (Phentolamine, Terazosin, etc.) ? Within the last 2 weeks: NSAIDs (Celecoxib, Ibuprofen, etc.) ? Within the last 2 weeks: Analgesics (Paracetamol, Trazodone, etc.) ? Within the last 2 weeks: Muscle relaxants (Diazepam, Baclofen, etc.) ? Within the last 2 weeks: Steroids (Prednisone, etc.) ? Within the last 3 weeks: Tricyclic antidepressants (Amitriptyline, etc.) ? Within the last 3 weeks: Anticonvulsants (Pregabalin, Gabapentin, Carbamazepine, etc.) Individuals with uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg, measured 10 minutes after stabilization for trial participants) Individuals who participated in another interventional clinical trial within the last 1 month or have plans to participate in another interventional clinical trial after the start of this clinical trial Individuals with skin abrasions, wounds, infections, or scars at the planned site of application of the investigational medical device during the clinical trial period Men with plans for pregnancy or without the intention to use appropriate contraception* during the clinical trial period *Condom, surgical infer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NIH-CPSI total score 4 weeks after end of 8-week intervention compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| NIH-CPSI total score at end of 8 weeks compared to baseline;Pain or discomfort, dysuria, and quality of life scores on the NIH-CPSI at the end of the 8-week intervention compared to baseline and 4 weeks after the end of the intervention;At the end of the 8-week intervention compared to baseline, VAS 4 weeks after intervention;At the end of the 8-week intervention compared to baseline, IPSS 4 weeks after intervention;At the end of the 8-week intervention compared to baseline, IIEF 4 weeks after intervention | — |
Countries
Korea, Republic of
Contacts
Public ContactDongho Shin
Catholic Kwandong University International St.Mary's Hospital
Outcome results
None listed