NCT00913315

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 5, 2009

Status Verified

June 1, 2009

Enrollment Period

2 months

First QC Date

June 3, 2009

Last Update Submit

June 4, 2009

Conditions

Prostatitis

Keywords

prostatitisAdrenergic alpha-Antagoniststolterodine

Outcome Measures

Primary Outcomes (1)

  • National Institutes of Health Chronic Prostatitis Symptom Index

    4 months

Secondary Outcomes (2)

  • Peak urinary flow rate

    4 months

  • International Index of Erectile Function

    4 months

Study Arms (2)

tolterodine + tamsulosin

EXPERIMENTAL
Drug: tolterodineDrug: tamsulosin

tamsulosin + placebo

ACTIVE COMPARATOR
Drug: tamsulosinDrug: placebo

Interventions

tolterodineDRUG

4 mg of tolterodine ER

tolterodine + tamsulosin
tamsulosinDRUG

0.4 mg of tamsulosin once a day for 8 weeks

tamsulosin + placebotolterodine + tamsulosin
placeboDRUG

placebo once a day for 8 weeks

tamsulosin + placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400016, China

Location

Related 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.

    PMID: 19092152BACKGROUND

MeSH Terms

Conditions

Prostatitis

Interventions

Tolterodine TartrateTamsulosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenolsBenzenesulfonamidesSulfonamidesAmidesSulfonesSulfur Compounds

Study Officials

  • Yong Chen, M.D.

    Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Chen, MD

CONTACT

86-23-89011122cy0324@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 4, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

January 1, 2010

Last Updated

June 5, 2009

Record last verified: 2009-06

Locations

CN(1)