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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Incontinence

Intervention: Tolterodine ER 4 mg QD (Drug); Tamsulosin 0.4 mg QD (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Patient Perception of Treatment Benefit at Week 12:

Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12

Secondary outcome:

Micturition Diary- Change in number of urge incontinence episodes per 24 hours at week 1, week 6 and 12 relative to baseline.

Change in number of urge episodes per 24 hours at week 1, week 6 and 12 relative to baseline.

Change in number of micturitions per 24 hours at week 1, week 6 and 12 relative to baseline.

Change in number of daytime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline

Change in number of nighttime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline

Change in the average severity of the Urinary Sensation Scale at week 1, week 6, and week 12 relative to baseline

Change in number of OAB micturition episodes per 24 hours (OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 3) at week 1, week 6 and week 12 relative to baseline

Change in number of daytime OAB micturition episodes per 24 hours (OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 3) at week 1, week 6 and week 12 relative to baseline

Change in number of nighttime OAB micturition episodes per 24 hours. (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline

Change in number of severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline

Change in number of daytime severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline

Change in number of nighttime severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline

International Prostate Symptom Score (I-PSS):

Change in I-PSS total score at weeks 1, 6 and 12 relative to baseline

Change in I-PSS individual item scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) at weeks 1, 6 and 12 relative to baseline

Change in I-PSS irritative domain (Sum of Q2, Q4, and Q7) at weeks 1, 6 and 12 relative to baseline

Change in I-PSS obstructive domain (Sum of Q1, Q3, Q5, and Q6) at weeks 1, 6 and 12 relative to baseline

Change in I-PSS index score (Sum Q1 to Q7) at weeks 1, 6 and 12 relative to baseline

Change in I-PSS QoL score (Q8) at weeks 1, 6 and 12 relative to baseline

Patient perception of urgency:

Change in the Perception of Urgency Scale (3 point scale) at week 1, week 6 and week 12 relative to baseline

Change in Patient's Perception of Bladder Condition at week 1, week 6 and week 12 relative to baseline

Patient Perception of Treatment benefit at week 1 and week 6

Treatment benefit and treatment satisfaction questions will be completed at week 1 and week 6

Change in International Continence Society Male (ICSmaleLF) Questionnaire (long form modified) individual item scores at Week 1, Week 6 and Week 12 relative to baseline

Change in the total score of Overactive Bladder Questionnaire (OABq) and change in total scores for each domain of OABq at week 6 and week 12 relative to baseline

Change in the total score of International Index of Erectile Function (IIEF) and change in total scores for each domain of IIEF Questionnaire at week 6 and week 12 relative to baseline

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Locations and Contacts

Pfizer Investigational Site, Birmingham, Alabama, United States

Pfizer Investigational Site, Homewood, Alabama, United States

Pfizer Investigational Site, Tucson, Arizona, United States

Pfizer Investigational Site, Anaheim, California, United States

Pfizer Investigational Site, Culver City, California, United States

Pfizer Investigational Site, Fresno, California, United States

Pfizer Investigational Site, La Mesa, California, United States

Pfizer Investigational Site, Long Beach, California, United States

Pfizer Investigational Site, Los Angeles, California, United States

Pfizer Investigational Site, Murrieta, California, United States

Pfizer Investigational Site, Poway, California, United States

Pfizer Investigational Site, San Bernardino, California, United States

Pfizer Investigational Site, Santa Monica, California, United States

Pfizer Investigational Site, Aurora, Colorado, United States

Pfizer Investigational Site, Boulder, Colorado, United States

Pfizer Investigational Site, Denver, Colorado, United States

Pfizer Investigational Site, New Britain, Connecticut, United States

Pfizer Investigational Site, Waterbury, Connecticut, United States

Pfizer Investigational Site, Melbourne, Florida, United States

Pfizer Investigational Site, Ocala, Florida, United States

Pfizer Investigational Site, Pembroke Pines, Florida, United States

Pfizer Investigational Site, Tallahassee, Florida, United States

Pfizer Investigational Site, Wellington, Florida, United States

Pfizer Investigational Site, Atlanta, Georgia, United States

Pfizer Investigational Site, Columbus, Georgia, United States

Pfizer Investigational Site, Roswell, Georgia, United States

Pfizer Investigational Site, Melrose Park, Illinois, United States

Pfizer Investigational Site, Evansville, Indiana, United States

Pfizer Investigational Site, Jeffersonville, Indiana, United States

Pfizer Investigational Site, Iowa City, Iowa, United States

Pfizer Investigational Site, Overland Park, Kansas, United States

Pfizer Investigational Site, Shreveport, Louisiana, United States

Pfizer Investigational Site, Boston, Massachusetts, United States

Pfizer Investigational Site, Brighton, Massachusetts, United States

Pfizer Investigational Site, Watertown, Massachusetts, United States

Pfizer Investigational Site, Columbia, Missouri, United States

Pfizer Investigational Site, O'Fallon, Missouri, United States

Pfizer Investigational Site, St. Louis, Missouri, United States

Pfizer Investigational Site, Missoula, Montana, United States

Pfizer Investigational Site, Henderson, Nevada, United States

Pfizer Investigational Site, Las Vegas, Nevada, United States

Pfizer Investigational Site, Cherry Hill, New Jersey, United States

Pfizer Investigational Site, Edison, New Jersey, United States

Pfizer Investigational Site, Hamilton, New Jersey, United States

Pfizer Investigational Site, Lawrenceville, New Jersey, United States

Pfizer Investigational Site, Marlton, New Jersey, United States

Pfizer Investigational Site, Mt. Laurel, New Jersey, United States

Pfizer Investigational Site, Sewell, New Jersey, United States

Pfizer Investigational Site, Voorhees, New Jersey, United States

Pfizer Investigational Site, Westhampton, New Jersey, United States

Pfizer Investigational Site, Woodbury, New Jersey, United States

Pfizer Investigational Site, ALbuquerque, New Mexico, United States

Pfizer Investigational Site, Albany, New York, United States

Pfizer Investigational Site, Bayshore, New York, United States

Pfizer Investigational Site, Carmel, New York, United States

Pfizer Investigational Site, Cortlandt Manor, New York, United States

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Pfizer Investigational Site, Manhasset, New York, United States

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Pfizer Investigational Site, Orchard Park, New York, United States

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Pfizer Investigational Site, Bryn Mawr, Pennsylvania, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania, United States

Pfizer Investigational Site, State College, Pennsylvania, United States

Pfizer Investigational Site, Wynnewood, Pennsylvania, United States

Pfizer Investigational Site, Providence, Rhode Island, United States

Pfizer Investigational Site, Charleston, South Carolina, United States

Pfizer Investigational Site, Greenwood, South Carolina, United States

Pfizer Investigational Site, Greer, South Carolina, United States

Pfizer Investigational Site, Prosperity, South Carolina, United States

Pfizer Investigational Site, Saluda, South Carolina, United States

Pfizer Investigational Site, Germantown, Tennessee, United States

Pfizer Investigational Site, Milan, Tennessee, United States

Pfizer Investigational Site, Arlington, Texas, United States

Pfizer Investigational Site, Austin, Texas, United States

Pfizer Investigational Site, Houston, Texas, United States

Pfizer Investigational Site, San Antonio, Texas, United States

Pfizer Investigational Site, Provo, Utah, United States

Pfizer Investigational Site, Alexandria, Virginia, United States

Pfizer Investigational Site, Arlington, Virginia, United States

Pfizer Investigational Site, Charlotesville, Virginia, United States

Pfizer Investigational Site, Fairfax, Virginia, United States

Pfizer Investigational Site, Virginia Beach, Virginia, United States

Pfizer Investigational Site, Spokane, Washington, United States

Pfizer Investigational Site, Tacoma, Washington, United States

Pfizer Investigational Site, Cheyenne, Wyoming, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2004
Last updated: June 7, 2011

Page last updated: August 23, 2015

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