Prostatitis
Conditions
Keywords
prostatitis, Adrenergic alpha-Antagonists, tolterodine
Brief summary
The purpose of this study is to determine whether tamsulosin and tolterodine are effective in the treatment of men with lower urinary tract symptoms and chronic prostatitis/chronic pelvic pain syndrome.
Detailed description
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder in urological clinics. Most of the clinically CP/CPPS are to some extent associated with storage (irritative) symptoms, such as increased frequency, urgency, and nocturia, namely many patients with CP/CPPS have overactive bladder symptoms. Alpha-blocker therapy has been advocated as a treatment modality for CP/CPPS. Some trials showed a statistically and likely clinically significant treatment effect, while other trials showed no benefit. Therefore, tamsulosin combination with tolterodine treatment for CP/CPPS may be more effective than tamsulosin single.
Interventions
DRUGtolterodine
4 mg of tolterodine ER
DRUGtamsulosin
0.4 mg of tamsulosin once a day for 8 weeks
DRUGplacebo
placebo once a day for 8 weeks
Sponsors
Fuling Central Hospital of Chongqing City
Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. diagnosis of CP/CPPS based on the classification of US National Institutes of Health, aged 18-45 years 2. total score of at least 12 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) 3. urinary score of at least 4 on the CPSI 4. subjects who anticipate improving symptoms
Exclusion criteria
1. previous treatment with any other alpha-adrenergic receptor blocker and antimuscarinic agents for symptoms of CP/CPPS or for any other reason 2. those who had had previous urinary tract infection with the last year 3. those who had been treat or were taking medication that could affect lower urinary tract function 4. those who met the criteria for chronic bacterial prostatitis after lower urinary tract localization studies 5. those who had other significant medical problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| National Institutes of Health Chronic Prostatitis Symptom Index | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Peak urinary flow rate | 4 months |
| International Index of Erectile Function | 4 months |
Countries
China
Contacts
Primary ContactYong Chen, MD
Outcome results
None listed