Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

Prostatitis Clinical Trial

— ESTTFCP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00913315
• Other study ID #: CQU023
• Status: Not yet recruiting
• Phase: N/A
• First received: June 3, 2009
• Last updated: June 4, 2009
• Start date: August 2009
• Est. completion date: January 2010

Study information

• Verified date: June 2009
• Source: Chongqing Medical University
• Contact: Yong Chen, MD
• Phone: 86-23-89011122
• Email: cy0324[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Prostatitis

Intervention

Drug:
• tolterodine
4 mg of tolterodine ER
• tamsulosin
0.4 mg of tamsulosin once a day for 8 weeks
• placebo
placebo once a day for 8 weeks

Locations

Country	Name	City	State
China	Department of Urology, the First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Chongqing Medical University	Fuling Central Hospital of Chongqing City

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Health Chronic Prostatitis Symptom Index		4 months	No
Secondary	Peak urinary flow rate		4 months	No
Secondary	International Index of Erectile Function		4 months	No