Effect of transurethral intraprostatic injection of botolinum toxin type A on chronic pelvic pain syndrome
- Conditions
- chronic pelvic pain syndrome.Other inflammatory diseases of prostate
- Registration Number
- IRCT201208051853N8
- Lead Sponsor
- rology Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 60
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chronic pelvic pain syndrome. Timepoint: before injection, 1,3,6 months after injection. Method of measurement: NIH-CPSI questionnaire.
- Secondary Outcome Measures
Name Time Method 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.