chronic prostatitis / chronic pelvic pain syndrom MedDRA version: 9.1 Level: LLT Classification code 10021965 Term: Inflammation pelvic
Conditions
Interventions
Trade Name: Botox (TM)
Product Name: Botox (R)
Pharmaceutical Form: Injection*
CAS Number: 8000049323
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: e
Sponsors
Department of Urology and Pediatric Urology - Justus-Liebig-University Giessen
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: Prostatitis other than NIH III Malformation of the urogenital tract subvesical obstruction urinary infection Cancer of the urogenital tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Pain Reduction measured by NIH-CPSI;Secondary Objective: NIH-CPSI, IPSS, PUF, VAS urodynamic parameters 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. | — |
Countries
Germany
Outcome results
None listed