Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy Study of Tamsulosin and Tolterodine Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Lower Urinary Tract Symptoms

Conditions
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Prostatitis

Intervention / Treatment
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* Drug: tolterodine
* Drug: tamsulosin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of CP/CPPS based on the classification of US National Institutes of Health, aged 18-45 years total score of at least 12 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) urinary score of at least 4 on the CPSI subjects who anticipate improving symptoms Exclusion Criteria: previous treatment with any other alpha-adrenergic receptor blocker and antimuscarinic agents for symptoms of CP/CPPS or for any other reason those who had had previous urinary tract infection with the last year those who had been treat or were taking medication that could affect lower urinary tract function those who met the criteria for chronic bacterial prostatitis after lower urinary tract localization studies those who had other significant medical problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tolterodine + tamsulosin<br> | Drug: tolterodine<br>* 4 mg of tolterodine ER<br>Drug: tamsulosin<br>* 0.4 mg of tamsulosin once a day for 8 weeks<br>|
| Active Comparator: tamsulosin + placebo<br> | Drug: tamsulosin<br>* 0.4 mg of tamsulosin once a day for 8 weeks<br>Drug: placebo<br>* placebo once a day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Chronic Prostatitis Symptom Index |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak urinary flow rate |  | 4 months | 
| International Index of Erectile Function |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostatitis, Adrenergic alpha-Antagonists, tolterodine