Intraprostatic injection of Botulinumtoxin type A in patients with chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) - CP(BTX)PS
- Conditions
- chronic prostatitis / chronic pelvic pain syndromMedDRA version: 9.1Level: LLTClassification code 10021965Term: Inflammation pelvic
- Registration Number
- EUCTR2007-001602-24-DE
- Lead Sponsor
- Department of Urology and Pediatric Urology - Justus-Liebig-University Giessen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with CP/CPPS (NIH IIIa/b) for more than 1 year
NIH-CPSI > 10
Volume of the prostatic gland 15-50ml
age 18-80 y
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Prostatitis other than NIH III
Malformation of the urogenital tract
subvesical obstruction
urinary infection
Cancer of the urogenital tract
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Pain Reduction measured by NIH-CPSI;Secondary Objective: NIH-CPSI, IPSS, PUF, VAS<br>urodynamic parameters<br>savety of the medication;Primary end point(s): Reduction of at least 3 score points of the NIH-CPSI questionnaire (German version) 3 months after administration of BTX in patients having received BTX and Tamsulosin in comparison to patients having received Tamsulosin only.<br>
- Secondary Outcome Measures
Name Time Method