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

Primary Purpose

Prostatitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tolterodine
tamsulosin
placebo
Sponsored by
Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatitis focused on measuring prostatitis, Adrenergic alpha-Antagonists, tolterodine

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Urology, the First Affiliated Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tolterodine + tamsulosin

tamsulosin + placebo

Arm Description

Outcomes

Primary Outcome Measures

National Institutes of Health Chronic Prostatitis Symptom Index

Secondary Outcome Measures

Peak urinary flow rate
International Index of Erectile Function

Full Information

First Posted
June 3, 2009
Last Updated
June 4, 2009
Sponsor
Chongqing Medical University
Collaborators
Fuling Central Hospital of Chongqing City
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1. Study Identification

Unique Protocol Identification Number
NCT00913315
Brief Title
Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis
Acronym
ESTTFCP
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

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chongqing Medical University
Collaborators
Fuling Central Hospital of Chongqing City

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatitis
Keywords
prostatitis, Adrenergic alpha-Antagonists, tolterodine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tolterodine + tamsulosin
Arm Type
Experimental
Arm Title
tamsulosin + placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
tolterodine
Intervention Description
4 mg of tolterodine ER
Intervention Type
Drug
Intervention Name(s)
tamsulosin
Intervention Description
0.4 mg of tamsulosin once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo once a day for 8 weeks
Primary Outcome Measure Information:
Title
National Institutes of Health Chronic Prostatitis Symptom Index
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Peak urinary flow rate
Time Frame
4 months
Title
International Index of Erectile Function
Time Frame
4 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Chen, MD
Phone
86-23-89011122
Email
cy0324@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Chen, M.D.
Organizational Affiliation
Chongqing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, the First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohou Wu, MD
Phone
86-2389011122
Email
93404840@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
19092152
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.
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Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

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