Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-01-31

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.

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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.

Conditions

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Prostatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tolterodine + tamsulosin

Group Type EXPERIMENTAL

tolterodine

Intervention Type DRUG

4 mg of tolterodine ER

tamsulosin

Intervention Type DRUG

0.4 mg of tamsulosin once a day for 8 weeks

tamsulosin + placebo

Group Type ACTIVE_COMPARATOR

tamsulosin

Intervention Type DRUG

0.4 mg of tamsulosin once a day for 8 weeks

placebo

Intervention Type DRUG

placebo once a day for 8 weeks

Interventions

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tolterodine

4 mg of tolterodine ER

Intervention Type DRUG

tamsulosin

0.4 mg of tamsulosin once a day for 8 weeks

Intervention Type DRUG

placebo

placebo once a day for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No