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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00913315
Recruitment Status : Unknown
Verified June 2009 by Chongqing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : June 4, 2009
Last Update Posted : June 5, 2009
Fuling Central Hospital of Chongqing City
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Prostatitis Drug: tolterodine Drug: tamsulosin Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy Study of Tamsulosin and Tolterodine Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Lower Urinary Tract Symptoms
Study Start Date : August 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. National Institutes of Health Chronic Prostatitis Symptom Index [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Peak urinary flow rate [ Time Frame: 4 months ]
  2. International Index of Erectile Function [ Time Frame: 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00913315

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Contact: Yong Chen, MD 86-23-89011122

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China, Chongqing
Department of Urology, the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Contact: Xiaohou Wu, MD    86-2389011122   
Sponsors and Collaborators
Chongqing Medical University
Fuling Central Hospital of Chongqing City
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Principal Investigator: Yong Chen, M.D. Chongqing Medical University
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Responsible Party: Yong Chen, Urology department , Fuling Central Hospital of Chongqing Identifier: NCT00913315    
Other Study ID Numbers: CQU023
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: June 5, 2009
Last Verified: June 2009
Keywords provided by Chongqing Medical University:
Adrenergic alpha-Antagonists
Additional relevant MeSH terms:
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Prostatic Diseases
Tolterodine Tartrate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents