Urinary IncontinencePhase 4NCT00147654

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

A Phase 4 study testing Tolterodine ER 4 mg QD and Tamsulosin 0.4 mg QD in people with Urinary Incontinence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 95 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 40 years and older, men only
Conditions the study is for: Urinary Incontinence
What is being tested?: Tolterodine ER 4 mg QD and Tamsulosin 0.4 mg QD
How many people: 830 participants
Where: 95 sitesUnited States
Study dates: Nov 2004to May 2006
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

95 sites in 1 country.

City, postcode or hospital

95 sites in 1 country

United States95 sites

Pfizer Investigational Site
Albany, New York
Pfizer Investigational Site
Albuquerque, New Mexico
Pfizer Investigational Site
Alexandria, Virginia
Pfizer Investigational Site
Allentown, Pennsylvania
Pfizer Investigational Site
Anaheim, California
Pfizer Investigational Site
Arlington, Texas
Pfizer Investigational Site
Arlington, Virginia
Pfizer Investigational Site
Atlanta, Georgia
Pfizer Investigational Site
Aurora, Colorado
Pfizer Investigational Site
Austin, Texas
Pfizer Investigational Site
Bala-Cynwyd, Pennsylvania
Pfizer Investigational Site
Bay Shore, New York
Pfizer Investigational Site
Birmingham, Alabama
Pfizer Investigational Site
Boston, Massachusetts
Pfizer Investigational Site
Boulder, Colorado
Pfizer Investigational Site
Brighton, Massachusetts
Pfizer Investigational Site
Bryn Mawr, Pennsylvania
Pfizer Investigational Site
Carmel, New York
Pfizer Investigational Site
Charleston, South Carolina
Pfizer Investigational Site
Charlottesville, Virginia
Pfizer Investigational Site
Cherry Hill, New Jersey
Pfizer Investigational Site
Cheyenne, Wyoming
Pfizer Investigational Site
Cincinnati, Ohio
Pfizer Investigational Site
Cleveland, Ohio
Pfizer Investigational Site
Columbia, Missouri
Pfizer Investigational Site
Columbus, Georgia
Pfizer Investigational Site
Columbus, Ohio
Pfizer Investigational Site
Cortlandt Manor, New York
Pfizer Investigational Site
Culver City, California
Pfizer Investigational Site
Denver, Colorado
Pfizer Investigational Site
Edison, New Jersey
Pfizer Investigational Site
Evansville, Indiana
Pfizer Investigational Site
Fairfax, Virginia
Pfizer Investigational Site
Fresno, California
Pfizer Investigational Site
Garden City, New York
Pfizer Investigational Site
Germantown, Tennessee
Pfizer Investigational Site
Greenwood, South Carolina
Pfizer Investigational Site
Greer, South Carolina
Pfizer Investigational Site
Hamilton, New Jersey
Pfizer Investigational Site
Henderson, Nevada
Pfizer Investigational Site
Homewood, Alabama
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Iowa City, Iowa
Pfizer Investigational Site
Jeffersonville, Indiana
Pfizer Investigational Site
La Mesa, California
Pfizer Investigational Site
Las Vegas, Nevada
Pfizer Investigational Site
Lawrenceville, New Jersey
Pfizer Investigational Site
Long Beach, California
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
Manhasset, New York
Pfizer Investigational Site
Marlton, New Jersey
Pfizer Investigational Site
Melbourne, Florida
Pfizer Investigational Site
Melrose Park, Illinois
Pfizer Investigational Site
Milan, Tennessee
Pfizer Investigational Site
Missoula, Montana
Pfizer Investigational Site
Mount Laurel, New Jersey
Pfizer Investigational Site
Murrieta, California
Pfizer Investigational Site
New Britain, Connecticut
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
O'Fallon, Missouri
Pfizer Investigational Site
Ocala, Florida
Pfizer Investigational Site
Oklahoma City, Oklahoma
Pfizer Investigational Site
Orchard Park, New York
Pfizer Investigational Site
Overland Park, Kansas
Pfizer Investigational Site
Pembroke Pines, Florida
Pfizer Investigational Site
Philadelphia, Pennsylvania
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
Poughkeepsie, New York
Pfizer Investigational Site
Poway, California
Pfizer Investigational Site
Prosperity, South Carolina
Pfizer Investigational Site
Providence, Rhode Island
Pfizer Investigational Site
Provo, Utah
Pfizer Investigational Site
Roswell, Georgia
Pfizer Investigational Site
Saluda, South Carolina
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
San Bernardino, California
Pfizer Investigational Site
Santa Monica, California
Pfizer Investigational Site
Sewell, New Jersey
Pfizer Investigational Site
Shreveport, Louisiana
Pfizer Investigational Site
Spokane, Washington
Pfizer Investigational Site
St Louis, Missouri
Pfizer Investigational Site
State College, Pennsylvania
Pfizer Investigational Site
Staten Island, New York
Pfizer Investigational Site
Syracuse, New York
Pfizer Investigational Site
Tacoma, Washington
Pfizer Investigational Site
Tallahassee, Florida
Pfizer Investigational Site
Tucson, Arizona
Pfizer Investigational Site
Virginia Beach, Virginia
Pfizer Investigational Site
Voorhees Township, New Jersey
Pfizer Investigational Site
Waterbury, Connecticut
Pfizer Investigational Site
Watertown, Massachusetts
Pfizer Investigational Site
Wellington, Florida
Pfizer Investigational Site
Westhampton, New Jersey
Pfizer Investigational Site
Woodbury, New Jersey
Pfizer Investigational Site
Wynnewood, Pennsylvania

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About this study

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

Conditions: Urinary Incontinence
Being tested: Tolterodine ER 4 mg QD, Tamsulosin 0.4 mg QD
Medical subject headings: Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tolterodine ER 4 mg QDDrug
Tamsulosin 0.4 mg QDDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Perception of Treatment Benefit at Week 12:
Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12

Secondary outcomes (27)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2004May 2006

First posted7 Sep 2005 (estimated)
Study startNov 2004
Study completionMay 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 830 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00147654
Sponsor's protocol ID: A6121120
Status last verified: Jan 2021
First submitted: 2 Sep 2005
Last updated: 27 Jan 2021
Results posted: No

Publications

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. doi: 10.1001/jama.296.19.2319.
PubMed 17105794

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00147654
Acronym / sponsor ID: A6121120
Conditions: Urinary Incontinence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 830 participants
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Nov 2004
Study completion: May 2006 (actual)
First posted: 7 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 40 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tolterodine ER 4 mg QD	Drug	–
Tamsulosin 0.4 mg QD	Drug	–

Primary outcome

Patient Perception of Treatment Benefit at Week 12:
Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12

27 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
Derived from this study: PubMed 17105794Kaplan 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. doi: 10.1001/jama.296.19.2319.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Urinary Incontinence

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

95 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Perception of Treatment Benefit at Week 12:. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00147654, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.