Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

Chongqing Medical University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prostatitis

Interventions

tolterodineDRUG

4 mg of tolterodine ER

tamsulosinDRUG

0.4 mg of tamsulosin once a day for 8 weeks

placeboDRUG

placebo once a day for 8 weeks

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Urology, the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Outcomes

Primary Outcomes

National Institutes of Health Chronic Prostatitis Symptom Index

Time frame: 4 months

Secondary Outcomes

Peak urinary flow rate

Time frame: 4 months

International Index of Erectile Function

Time frame: 4 months

Central Contacts

Yong Chen, MD

CONTACT

86-23-89011122 cy0324@yahoo.com.cn

Data from ClinicalTrials.gov

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