Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis (ESTTFCP)

June 4, 2009 updated by: Chongqing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Department of Urology, The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
National Institutes of Health Chronic Prostatitis Symptom Index
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak urinary flow rate
Time Frame: 4 months
4 months
International Index of Erectile Function
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Collaborators

Fuling Central Hospital of Chongqing City

Investigators

  • Principal Investigator: Yong Chen, M.D., Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

June 5, 2009

Last Update Submitted That Met QC Criteria

June 4, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQU023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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