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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Chongqing Medical University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913315
First Posted: June 4, 2009
Last Update Posted: June 5, 2009
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.
Collaborator:
Fuling Central Hospital of Chongqing City
Information provided by:
Chongqing Medical University
June 3, 2009
June 4, 2009
June 5, 2009
August 2009
October 2009   (Final data collection date for primary outcome measure)
National Institutes of Health Chronic Prostatitis Symptom Index [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT00913315 on ClinicalTrials.gov Archive Site
  • Peak urinary flow rate [ Time Frame: 4 months ]
  • International Index of Erectile Function [ Time Frame: 4 months ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Prostatitis
  • Drug: tolterodine
    4 mg of tolterodine ER
  • Drug: tamsulosin
    0.4 mg of tamsulosin once a day for 8 weeks
  • Drug: placebo
    placebo once a day for 8 weeks
  • Experimental: tolterodine + tamsulosin
    Interventions:
    • Drug: tolterodine
    • Drug: tamsulosin
  • Active Comparator: tamsulosin + placebo
    Interventions:
    • Drug: tamsulosin
    • Drug: placebo
Nickel JC, Krieger JN, McNaughton-Collins M, Anderson RU, Pontari M, Shoskes DA, Litwin MS, Alexander RB, White PC, Berger R, Nadler R, O'Leary M, Liong ML, Zeitlin S, Chuai S, Landis JR, Kusek JW, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med. 2008 Dec 18;359(25):2663-73. doi: 10.1056/NEJMoa0803240.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
January 2010
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00913315
CQU023
Yes
Not Provided
Not Provided
Yong Chen, Urology department , Fuling Central Hospital of Chongqing
Chongqing Medical University
Fuling Central Hospital of Chongqing City
Principal Investigator: Yong Chen, M.D. Chongqing Medical University
Chongqing Medical University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP