Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

Condition(s) targeted: Prostatitis

Intervention: tolterodine (Drug); tamsulosin (Drug); placebo (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Chongqing Medical University

Official(s) and/or principal investigator(s):
Yong Chen, M.D., Principal Investigator, Affiliation: Chongqing Medical University

Overall contact:
Yong Chen, MD, Phone: 86-23-89011122, Email: cy0324@yahoo.com.cn

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: National Institutes of Health Chronic Prostatitis Symptom Index

Secondary outcome:

Peak urinary flow rate

International Index of Erectile Function

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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

Yong Chen, MD, Phone: 86-23-89011122, Email: cy0324@yahoo.com.cn

Department of Urology, the First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China

Related publications:

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.

Starting date: August 2009
Ending date: January 2010
Last updated: June 4, 2009