Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

Not Applicable

• Conditions: Prostatitis
• Interventions: Drug: tolterodine; Drug: placebo; Drug: tamsulosin

• Registration Number: NCT00913315
• Lead Sponsor: Chongqing Medical University

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.

Study Timeline

• Status Verified: 2009-06
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Last Update Submitted: 2009-06-04
• Last Update Posted: 2009-06-05
• Study Start: 2009-08
• Primary Completion: 2009-10
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tamsulosin + placebo	placebo	-
tolterodine + tamsulosin	tolterodine	-
tolterodine + tamsulosin	tamsulosin	-
tamsulosin + placebo	tamsulosin	-

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Chronic Prostatitis Symptom Index	4 months

Secondary Outcome Measures

Name	Time	Method
International Index of Erectile Function	4 months
Peak urinary flow rate	4 months

Trial Locations

Locations (1)

Department of Urology, the First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China