Clinical trial NCT00913315: Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis
Official title: Efficacy Study of Tamsulosin and Tolterodine Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Lower Urinary Tract Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatitis
Keywords: prostatitis
Adrenergic alpha-Antagonists
tolterodine
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Fuling Central Hospital of Chongqing City
First posted: 2009-06-04
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: National Institutes of Health Chronic Prostatitis Symptom Index
timeFrame: 4 months
Secondary outcomes:
measure: Peak urinary flow rate
timeFrame: 4 months
measure: International Index of Erectile Function
timeFrame: 4 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Urology, the First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Chongqing Medical University
name: Yong Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.