Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis - Full Text View

Sponsors and Collaborators:	Chongqing Medical University Fuling Central Hospital
Information provided by:	Chongqing Medical University
ClinicalTrials.gov Identifier:	NCT00913315

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

MedlinePlus related topics: Pelvic Pain

Drug Information available for: Tamsulosin Tamsulosin hydrochloride Tolterodine Tolterodine tartrate

U.S. FDA Resources

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
tolterodine + tamsulosin: Experimental	Drug: tolterodine 4 mg of tolterodine ER Drug: tamsulosin 0.4 mg of tamsulosin once a day for 8 weeks
tamsulosin + placebo: Active Comparator	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:

diagnosis of CP/CPPS based on the classification of US National Institutes of Health, aged 18-45 years
total score of at least 12 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
urinary score of at least 4 on the CPSI
subjects who anticipate improving symptoms

Exclusion Criteria:

previous treatment with any other alpha-adrenergic receptor blocker and antimuscarinic agents for symptoms of CP/CPPS or for any other reason
those who had had previous urinary tract infection with the last year
those who had been treat or were taking medication that could affect lower urinary tract function
those who met the criteria for chronic bacterial prostatitis after lower urinary tract localization studies
those who had other significant medical problems

Contacts and Locations

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

Sponsors and Collaborators

Chongqing Medical University

Fuling Central Hospital

Investigators

Principal Investigator:

Yong Chen, M.D.

Chongqing Medical University

More Information

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.

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

Keywords provided by Chongqing Medical University:

prostatitis
Adrenergic alpha-Antagonists
tolterodine

Study placed in the following topic categories:

Neurotransmitter Agents
Prostatic Diseases
Adrenergic Agents
Cholinergic Antagonists
Pain
Adrenergic alpha-Antagonists
Cholinergic Agents

Genital Diseases, Male
Prostatitis
Muscarinic Antagonists
Pelvic Pain
Tamsulosin
Adrenergic Antagonists
Tolterodine

Additional relevant MeSH terms:

Neurotransmitter Agents
Cholinergic Antagonists
Prostatic Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Cholinergic Agents

Genital Diseases, Male
Pharmacologic Actions
Muscarinic Antagonists
Prostatitis
Therapeutic Uses
Tamsulosin
Adrenergic Antagonists
Tolterodine

ClinicalTrials.gov processed this record on September 10, 2009