chronic pelvic pain syndrome. Other inflammatory diseases of prostate
Conditions
Interventions
Intervention 1: transurethral intraprostatic injection of 20 U/ML Botolinum Toxsin type-A. Intervention 2: transurethral intraprostatic injection of 0.9% normal saline.
Treatment - Drugs
Placebo
transurethral intraprostatic injection of 20 U/ML Botolinum Toxsin type-A
transurethral intraprostatic injection of 0.9% normal saline
Sponsors
Urology Research Center
Eligibility
Sex/Gender
Male
Age
18 Years to 149 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: age>18; clinical diagnosis of CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least the past 3 months without evidence of bacterial infection; aggregate score of greater than or equal to 10 on the NIH-CPSI questionair; failed empirical therapy for 4-6 weeks Exclusion criteria: history of prostate; bladder or urethra cancer; pelvic radiation or systemic chemotherapy or intravesical chemotherapy; neurological disease affectin g the bladder; previous intraprostatic injection of BoNT-A; PVR>200 cc; history of prostate surgery; urinary catheter; cystostomy or nephrostomy; penile or urinary sphincter implants; PSA > age- specific range; coagulopathies; during the last month: intake of antibiotics,alpha-receptor blockers,anticholinergics; intake of analgesics containing opioids; during the last 3 months:documented urinary infection,epididymitis,positive urinary cultures,STD; during the last 6 months:5-alpha reductase inhibitor; during the last 12 months: genital herpes, not adjustable HTN; angina pectoris; heart failure; status post MI; coronary bypass surgery or coronary dilatation; during the last 24 months: cerebral insult; serum creatinin >2 mg/dl; hypersensitivity concerning any substances of content of BoNT-A or myasthenia gravis; abuse of drugs or alcohol during last 5 years
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic pelvic pain syndrome. Timepoint: before injection, 1,3,6 months after injection. Method of measurement: NIH-CPSI questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| IPSS total score. Timepoint: before injection, 1,3,6 months after injection. Method of measurement: IPSS questionnaire.;Patient's pain scaling. Timepoint: before injection, 1,3,6 months after injection. Method of measurement: Visual Analog Scale score questionnaire.;Patient's quality of life scoring. Timepoint: before injection, 1,3,6 months after injection. Method of measurement: QoL score questionnaire.;Max flow rate. Timepoint: before injection, 1,3,6 months after injection. Method of measurement: Uroflowmeter. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Elahe Shahab
Urology Research Center
Outcome results
None listed