Urinary IncontinencePhase 4NCT00143481
Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women
A Phase 4 study testing Tolterodine ER 4mg QD in people with Urinary Incontinence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 58 sites in United States.
Trial summary
The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Tolterodine ER 4mg QD
- How many people
- 400 participants
- Where
- 58 sitesUnited States
- Study dates
- Mar 2005to Jun 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female outpatients 18 years or older.
- Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months.
- Currently sexually active with a male partner.
Who cannot join
- Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction.
- Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
- Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period.
- Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87131-0001
Pfizer Investigational Site
Allentown, Pennsylvania, 18104
Pfizer Investigational Site
Alpharetta, Georgia, 30005
Pfizer Investigational Site
Austin, Texas, 78703
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Austin, Texas, 78756
Pfizer Investigational Site
Baltimore, Maryland, 21211
Pfizer Investigational Site
Baton Rouge, Louisiana, 70815
Pfizer Investigational Site
Berkeley, California, 94705
Pfizer Investigational Site
Bryan, Texas, 77802-1903
Pfizer Investigational Site
Chandler, Arizona, 85225
Pfizer Investigational Site
Cincinnati, Ohio, 45220
Pfizer Investigational Site
Cincinnati, Ohio, 45267
Pfizer Investigational Site
Clearwater, Florida, 33759
Pfizer Investigational Site
Cleveland, Ohio, 44122
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Columbus, Ohio, 43213
Pfizer Investigational Site
Conroe, Texas, 77304
Pfizer Investigational Site
Creve Coeur, Missouri, 63141
Pfizer Investigational Site
Denver, Colorado, 80202
Pfizer Investigational Site
Denver, Colorado, 80204
Pfizer Investigational Site
Evansville, Indiana, 47714
Pfizer Investigational Site
Farmington, Connecticut, 06032
Pfizer Investigational Site
Gallipolis, Ohio, 45631
Pfizer Investigational Site
Irving, Texas, 75061
Pfizer Investigational Site
Lakewood, Colorado, 80228
Pfizer Investigational Site
Las Vegas, Nevada, 89109
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Leesburg, Florida, 34748
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Metairie, Louisiana, 70002
Pfizer Investigational Site
Metairie, Louisiana, 70006
Pfizer Investigational Site
Miami, Florida, 33145
Pfizer Investigational Site
Morgantown, West Virginia, 26505
Pfizer Investigational Site
Morgantown, West Virginia, 26506-9251
Pfizer Investigational Site
New Bern, North Carolina, 28562
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
Newburgh, Indiana, 47630
Pfizer Investigational Site
North Las Vegas, Nevada, 89030
Pfizer Investigational Site
Oakland, California, 94612
Pfizer Investigational Site
Olean, New York, 14760
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19114
Pfizer Investigational Site
Phoenix, Arizona, 85013
Pfizer Investigational Site
Saginaw, Michigan, 48602
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
Salt Lake City, Utah, 84124
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
San Francisco, California, 94102
Pfizer Investigational Site
Santa Rosa, California, 95405
Pfizer Investigational Site
Seattle, Washington, 98105
Pfizer Investigational Site
South Bend, Indiana, 46601
Pfizer Investigational Site
West Hartford, Connecticut, 06117
Pfizer Investigational Site
West Palm Beach, Florida, 33409-1972
Pfizer Investigational Site
Weston, Florida, 33331
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multi-Center, Double-Phase, Randomized, Double-Blind, Placebo Controlled (12-Week Double-Blind Followed by 12-Week Open-Label) Study Evaluating the Effect of Tolterodine ER on Urgency Urinary Incontinence (UUI), Urgency, Frequency, Sexual Quality of Life and Sexual Function in Women With Overactive Bladder
The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.
- Conditions
- Urinary Incontinence
- Being tested
- Tolterodine ER 4mg 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 4mg QDDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
Secondary outcomes (5)
Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline
Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline
Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline
Reasons for treatment withdrawal
Adverse Events during the 24 week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 400 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143481
- Sponsor's protocol ID
- A6121002
- Status last verified
- Jan 2021
- First submitted
- 1 Sep 2005
- Last updated
- 27 Jan 2021
- Results posted
- No
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401Rogers RG, Bachmann G, Scarpero H, Jumadilova Z, Sun F, Morrow JD, Guan Z, Bavendam T. Effects of tolterodine ER on patient-reported outcomes in sexually active women with overactive bladder and urgency urinary incontinence. Curr Med Res Opin. 2009 Sep;25(9):2159-65. doi: 10.1185/03007990903103279.
PubMed 19601704Rogers R, Bachmann G, Jumadilova Z, Sun F, Morrow JD, Guan Z, Bavendam T. Efficacy of tolterodine on overactive bladder symptoms and sexual and emotional quality of life in sexually active women. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1551-7. doi: 10.1007/s00192-008-0688-6. Epub 2008 Aug 7.
PubMed 18685795
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 Multi-Center, Double-Phase, Randomized, Double-Blind, Placebo Controlled (12-Week Double-Blind Followed by 12-Week Open-Label) Study Evaluating the Effect of Tolterodine ER on Urgency Urinary Incontinence (UUI), Urgency, Frequency, Sexual Quality of Life and Sexual Function in Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00143481
- Acronym / sponsor ID
- A6121002
- Conditions
- Urinary Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jun 2006 (actual)
- First posted
- 2 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.
The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female outpatients 18 years or older.
- Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months.
- Currently sexually active with a male partner.
Key exclusion criteria (4 listed)
- Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction.
- Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
- Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period.
- Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)
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 4mg QD | Drug | – |
Primary outcome
Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
5 secondary outcomes
Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline
Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline
Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline
Reasons for treatment withdrawal
Adverse Events during the 24 week treatment period.
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 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
- Derived from this study: PubMed 19601704Rogers RG, Bachmann G, Scarpero H, Jumadilova Z, Sun F, Morrow JD, Guan Z, Bavendam T. Effects of tolterodine ER on patient-reported outcomes in sexually active women with overactive bladder and urgency urinary incontinence. Curr Med Res Opin. 2009 Sep;25(9):2159-65. doi: 10.1185/03007990903103279.
- Derived from this study: PubMed 18685795Rogers R, Bachmann G, Jumadilova Z, Sun F, Morrow JD, Guan Z, Bavendam T. Efficacy of tolterodine on overactive bladder symptoms and sexual and emotional quality of life in sexually active women. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1551-7. doi: 10.1007/s00192-008-0688-6. Epub 2008 Aug 7.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tolterodine ER 4mg QD in people with Urinary Incontinence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 58 sites in United States.
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 58 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?
Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.. 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 NCT00143481, which also lists 3 linked publications.
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.