You are here

Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urinary Incontinence
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male 40 years of age

- Clinical signs and symptoms of frequency and urgency, with or without UUI, with or
without BOO, for at least three months

- Mean urinary frequency of 8 micturitions/24h verified by the Screening micturition
diary

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Post-void residual urine volume (PVR) of > 200 ml as measured by an ultrasound

- Maximum urinary flow rate (Qmax) of volume of 75 ml is required in order to accurately record the Qmax

- Prescribed and administered an antimuscarinic or antispasmodic within 1 month

- Prescribed and administered an a-1-adrenergic antagonist within 2 weeks

NCT00147654
Pfizer
Completed
Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Neurogenic Urinary Bladder
NCT02501928
All Genders
6+
Years
Multiple Sites
Urinary Tract Infection (cUTI), Intra-abdominal Infection (cIAI) and, Nosocomial Pneumonia (NP)
NCT02364284
All Genders
18+
Years
Multiple Sites
Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction
A Randomized, Double Blind, Placebo Controlled, Four Arm (Placebo, Tolterodine ER, Tamsulosin, and Tolterodine ER Plus Tamsulosin) Study To Evaluate The Clinical Efficacy And Safety Of Tolterodine ER 4 mg In Men Who Have Frequency and Urgency, With Or Without Urinary Urge Incontinence, With Or Without Bladder Outlet Obstruction
The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Urinary Incontinence
  • Drug: Tolterodine ER 4 mg QD
  • Drug: Tamsulosin 0.4 mg QD
Not Provided
Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. Erratum in: JAMA. 2007 Mar 21:297(11):1195. JAMA. 2007 Oct 24;298(16):1864.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
830
May 2006
Not Provided

Inclusion Criteria:

  • Male 40 years of age
  • Clinical signs and symptoms of frequency and urgency, with or without UUI, with or without BOO, for at least three months
  • Mean urinary frequency of 8 micturitions/24h verified by the Screening micturition diary

Exclusion Criteria:

  • Post-void residual urine volume (PVR) of > 200 ml as measured by an ultrasound
  • Maximum urinary flow rate (Qmax) of < 5 ml/second as measured by a flowmeter; a voided volume of 75 ml is required in order to accurately record the Qmax
  • Prescribed and administered an antimuscarinic or antispasmodic within 1 month
  • Prescribed and administered an a-1-adrenergic antagonist within 2 weeks
Sexes Eligible for Study: Male
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00147654
A6121120
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now