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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Chongqing Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Fulin Central Hospital of Chongqing City
Information provided by:
Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT00913315
First received: June 3, 2009
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

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 Intervention
Prostatitis
Drug: tolterodine
Drug: tamsulosin
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Chongqing Medical University:

Primary Outcome Measures:
  • National Institutes of Health Chronic Prostatitis Symptom Index [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak urinary flow rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • International Index of Erectile Function [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913315

Contacts
Contact: Yong Chen, MD 86-23-89011122 cy0324@yahoo.com.cn

Locations
China, Chongqing
Department of Urology, the First Affiliated Hospital of Chongqing Medical University Not yet recruiting
Chongqing, Chongqing, China, 400016
Contact: Xiaohou Wu, MD    86-2389011122    93404840@qq.com   
Sponsors and Collaborators
Chongqing Medical University
Fulin Central Hospital of Chongqing City
Investigators
Principal Investigator: Yong Chen, M.D. Chongqing Medical University
  More Information

Publications:
Responsible Party: Yong Chen, Urology department , Fuling Central Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT00913315     History of Changes
Other Study ID Numbers: CQU023
Study First Received: June 3, 2009
Last Updated: June 4, 2009
Health Authority: China: Ministry of Health

Keywords provided by Chongqing Medical University:
prostatitis
Adrenergic alpha-Antagonists
tolterodine

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Prostatitis
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms
Urological Manifestations
Phenylpropanolamine
Tamsulosin
Tolterodine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Agonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Anti-Obesity Agents
Appetite Depressants
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on October 30, 2014