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Urinary Bladder, OveractivePhase 4NCT01302054

A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.

A Phase 4 study testing Fesoterodine 8 mg in people with Urinary Bladder, Overactive, run by Pfizer at 176 sites in 15 countries.

Completed

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

Official record
Search all trials

Trial summary

Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder, Overactive
What is being tested?
Fesoterodine 8 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
990 participants
Where
176 sitesin 15 countries
Study dates
May 2011to May 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of overactive bladder with symptoms for at least 6 months.
  • Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine
  • Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception

Who cannot join

  • Conditions or prior treatment that may also affect bladder function
  • Clinically significant urinary tract infection (UTI)
  • Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).

Trial locations and contacts

176 sites in 15 countries.

176 sites in 15 countries

United States109 sites

  • Radiant Research, Inc.

    Akron, Ohio, 44311

  • Northeast Urogynecology

    Albany, New York, 12205

  • The Urologic Institute of Northeastern New York - Community Care Physicians, PC

    Albany, New York, 12208

  • Atlanta Medical Research Institute, LLC

    Alpharetta, Georgia, 30005

  • Radiant Research, Inc.

    Anderson, South Carolina, 29621

  • Integra Trials, LLC

    Arlington, Virginia, 22205

  • Washington Urology

    Arlington, Virginia, 22205

  • Radiant Research, Inc.

    Atlanta, Georgia, 30342

  • Fox Valley Clinical Research Center, LLC

    Aurora, Illinois, 60504

  • Adult Care of Austin

    Austin, Texas, 78745

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • Urologic Consultants of Southeastern Pennsylvania

    Bala-Cynwyd, Pennsylvania, 19004

  • DiscoveResearch, Inc.

    Beaumont, Texas, 77701

  • Beaumont Internal Medicine & Geriatric Associates

    Beaumont, Texas, 77702

  • Radiant Research, Inc.

    Birmingham, Alabama, 35209

  • Alabama Internal Medicine, PC

    Birmingham, Alabama, 35235

  • Manatee Medical Research Institute, LLC

    Bradenton, Florida, 34205

  • DiscoveResearch, Inc.

    Bryan, Texas, 77802

  • DiscoveResearch, Incorporated

    Bryan, Texas, 77802

  • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

    Cary, North Carolina, 27518

  • Radiant Research, Inc.

    Chandler, Arizona, 85225

  • PMG Research of Charlotte

    Charlotte, North Carolina, 28209

  • Urology Specialists of the Carolinas

    Charlotte, North Carolina, 28210

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404

  • OB-GYN Centre of Excellence

    Chattanooga, Tennessee, 37404

  • Radiant Research, Inc.

    Chicago, Illinois, 60654

  • Radiant Research, Inc.

    Cincinnati, Ohio, 45249

  • Columbia Women's Healthcare, LLC

    Columbia, South Carolina, 29201

  • SC Clinical Research Center, LLC

    Columbia, South Carolina, 29201

  • Radiant Research, Inc.

    Columbus, Ohio, 43212

  • Radiant Research, Inc.

    Dallas, Texas, 75231

  • Providence Health Partners - Center for Clinical Research

    Dayton, Ohio, 45439

  • Atlantic Institute of Clinical Research

    Daytona Beach, Florida, 32114

  • SJS Clinical Research

    Destin, Florida, 32541

  • In-Quest Medical Research, LLC

    Duluth, Georgia, 30096

  • Gilbert Teixeira, DO

    East Providence, Rhode Island, 02914

  • Pharma Resource

    East Providence, Rhode Island, 02915

  • Radiant Research, Inc.

    Edina, Minnesota, 55435

  • OB/GYN Associates of Erie

    Erie, Pennsylvania, 16507

  • Pacific Women's Center, LLC

    Eugene, Oregon, 97401

  • Brown and McCool Gynecology

    Fairhope, Alabama, 36532

  • New England Center for Clinical Research Fall River, LLC

    Fall River, Massachusetts, 02720

  • Lillestol Research LLC

    Fargo, North Dakota, 58103

  • Eclipse Clinical Research

    Green Valley, Arizona, 85614

  • Radiant Research, Inc.

    Greer, South Carolina, 29651

  • Thameside Obstetrics/Gynecological Center

    Groton, Connecticut, 06340

  • S.H.E. Medical Associates

    Hartford, Connecticut, 06105

  • Advances In Health, Inc.

    Houston, Texas, 77030

  • Centex Research, Inc. - Pineloch Medical Clinic

    Houston, Texas, 77062

  • The Office of Dr. Steven Maislos, MD

    Houston, Texas, 77074

  • CRC of Jackson

    Jackson, Mississippi, 39202

  • Women's Specialty Center

    Jackson, Mississippi, 39202

  • Advanced Therapeutics, Inc.

    Johnson City, Tennessee, 37601

  • Johnson City Internal Medicine

    Johnson City, Tennessee, 37604

  • Beyer Research

    Kalamazoo, Michigan, 49009

  • Francis Jimenez, MD

    Las Vegas, Nevada, 89102

  • Impact Clinical Trials

    Las Vegas, Nevada, 89106

  • Richard M. Groom, MD

    Las Vegas, Nevada, 89106

  • American Institute of Research

    Los Angeles, California, 90017

  • Moaz Khorsandi, DO

    Los Angeles, California, 90017

  • Urology Group of Southern California

    Los Angeles, California, 90017

  • Institute for Advanced Urology

    Los Angeles, California, 90048

  • Integrity Medical Research, LLC

    Mountlake Terrace, Washington, 98043

  • Urology Northwest, PA

    Mountlake Terrace, Washington, 98043

  • PMG Research of Charleston, LLC

    Mt. Pleasant, South Carolina, 29464

  • Radiant Research, Inc.

    Murray, Utah, 84123

  • New England Center for Clinical Research of Massachusetts, LLC

    New Bedford, Massachusetts, 02740

  • University Urology Associates

    New York, New York, 10016

  • Urology of Indiana, LLC

    Noblesville, Indiana, 46062

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • Ocala Urology Specialists

    Ocala, Florida, 34471

  • Renstar Medical Research, Inc.

    Ocala, Florida, 34471

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Associated Medical Professionals of New York, PLLC

    Oneida, New York, 13421

  • Radiant Research, Inc.

    Overland Park, Kansas, 66202

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • Advanced Urology, PC

    Parker, Colorado, 80134

  • Memorial Hospital of Rhode Island - Clinical Studies Center

    Pawtucket, Rhode Island, 02860

  • Research Protocol Management Specialists

    Pittsburgh, Pennsylvania, 15243

  • Village Health Partners

    Plano, Texas, 75024

  • Accord Clinical Research, LLC

    Port Orange, Florida, 32129

  • PMG Research of Raleigh, LLC

    Raleigh, North Carolina, 27609

  • Prism Research Group

    Rome, Georgia, 30165

  • Valley Health Care

    Rome, Georgia, 30165

  • Sierra Clinical Research

    Roseville, California, 95661

  • Superior Research LLC

    Sacramento, California, 95825

  • PMG Research of Salisbury, LLC

    Salisbury, North Carolina, 28144

  • Salibury Urological Clinic

    Salisbury, North Carolina, 28144

  • Paragon Research Center, LLC

    San Antonio, Texas, 78205

  • California Research Foundation

    San Diego, California, 92103

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Adult and Pediatric Urology

    Sartell, Minnesota, 56377

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • The Urology Group

    Southaven, Mississippi, 38671

  • North Spokane Women's Clinic

    Spokane, Washington, 99207

  • Radiant Research, Inc.

    St Louis, Missouri, 63141

  • Pinellas Urology, Inc.

    St. Petersburg, Florida, 33710

  • Associated Medical Professionals of NY

    Syracuse, New York, 13210

  • Florida Urology Partners

    Tampa, Florida, 33607

  • Medical Research Associates, Inc.

    Traverse City, Michigan, 49684

  • Radiant Research, Inc.

    Tucson, Arizona, 85710

  • Urological Associates of Southern Arizona, PC

    Tucson, Arizona, 85715

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Bay State Clinical Trials, Inc.

    Watertown, Massachusetts, 02472

  • The Office of Georgis Patsias, MD, PA

    Wellington, Florida, 33449

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Carolina Urological Associates

    Winston-Salem, North Carolina, 27103

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada11 sites

  • The Male/Female Health and Research Centre, Royal Court Medical Centre

    Barrie, Ontario, L4M 7G1

  • Maritime Research Center

    Bathurst, New Brunswick, E2A 4X7

  • Maritime Research Center

    Bathurst, New Brunswick, E2A 4Z9

  • The Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

  • Lois Hole Hospital for Women, Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Centre for Applied Urological Research, Queen's University, Kingston General Hospital

    Kingston, Ontario, K7L 3J7

  • Diex Research Montreal Inc.

    Montreal, Quebec, H4N 3C5

  • URLX Corporation

    Ottawa, Ontario, K1H 1A2

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Germany11 sites

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • Klinische Forschung Berlin

    Berlin, 10787

  • Praxis fuer Urologie

    Berlin, 14052

  • Duisburger Fachaerztegemeinschaft

    Duisburg, 47179

  • ZKS Suedbrandenburg GmbH

    Elsterwerda, 04910

  • Facharzt für Frauenheilkunde und Geburtshilfe

    Frankfurt am Main, 60322

  • Urologische Praxis

    Hagenow, 19230

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253

  • Arztpraxis Dr. von Keitz

    Marburg, 35039

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Mittweida, 09648

  • Frauenarzt Praxis

    München, 81241

Other trials in Germany

Ukraine8 sites

  • Regional Clinical Hospital, Department of Urology of Dnipropetrovsk State Medical Academy

    Dnipropetrovsk, 49005

  • Regional Clinical Center of Urology and Nephrology

    Kharkiv, 61037

  • Institute of Urology of AMS of Ukraine

    Kyiv, 04053

  • Lugansk City Multi-Discipline Hospital #2, department of Urology

    Luhansk

  • 5Th City Clinical Hospital, Urology Department

    Lviv, 79059

  • LTD Out-patient clinic of General practice and Family medicine

    Odesa, 65009

  • Poltava Regional Clinical Hospital, Department of Urology

    Poltava

  • Municipal Institution of Ternopil Regional Council, Ternopil University Hospital

    Ternopil, 46002

Other trials in Ukraine

Russia7 sites

  • Kemerovо Regional Perinatal Center

    Kemerovo, 650066

  • Moscow State Healthcare Institution City Clinical Hospital #12

    Moscow, 115516

  • Saint-Petersburg State Budgetary Healthcare Institution City Hospital #26

    Saint Petersburg, 196247

  • Saint-Petersburg State Medical University I.P.Pavlov

    Saint Petersburg, 197022

  • Saint-Petersburg State Healthcare Institution City Hospital # 15

    Saint Petersburg, 198205

  • St. Petersburg State Healthcare Institution

    Saint Petersburg, 199106

  • Siberian State Medical University

    Tomsk, 634050

Other trials in Russia

Sweden6 sites

  • Kvinnohalsan Soder

    Bandhagen, 124 54

  • Specialistmottagningen i urologi

    Gothenburg, 405 45

  • Partus Kvinnohalsa

    Gothenburg, 412 54

  • Me3plus Clinical Trials

    Gothenburg, 41263

  • Tudorkliniken, Specialistmottagningen i Urologi

    Halmstad, 302 46

  • Vrinnevisjukhuset

    Norrköping, 601 82

Other trials in Sweden

Bulgaria5 sites

  • MBAL Trimontsium OOD

    Plovdiv, 4000

  • MBAL Ruse AD, Urologichno otdelenie,

    Rousse, 7002

  • UMBAL Aleksandrovska EAD

    Sofia, 1431

  • MBALSM N.I.Pirogov EAD

    Sofia, 1606

  • MBAL Doverie AD, Otdelenie po urologia

    Sofia, 1632

Other trials in Bulgaria

Czechia4 sites

  • Prvni privatni chirurgicke centrum spol. s .r.o. - SANUS

    Hradec Králové, 500 02

  • Nemocnice Jindrichuv Hradec

    Jindřichův Hradec, 377 38

  • Oblastni nemocnice Kolin, a.s.

    Kolin III, 28000

  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

    Ústí nad Labem, 401 13

Other trials in Czechia

Hungary4 sites

  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar Urologiai Klinika

    Budapest, 1082

  • Soproni Erzsebet Oktato Korhaz, Urologiai Osztaly

    Sopron, 9400

  • Donatella 99 Bt.

    Szentes, 6600

  • MAV Korhaz es Rendelointezet, Urologia

    Szolnok, 5000

Other trials in Hungary

Poland3 sites

  • NZOZ VIP - MED, Poradnia Urologiczna

    Gdynia, 81-366

  • SP ZOZ Wojewodzki Szpital Specjalistyczny im. J. Koraczaka

    Słupsk, 76-200

  • Specjalistyczny Gabinet Lekarski

    Warsaw, 02-926

Other trials in Poland

South Korea3 sites

  • Department of Urology, Pusan National University Hospital

    Pusan, 602-739

  • Department of Urology, Konkuk University Medical Center

    Seoul, 143-729

  • Department of Urology, Ajou University Hospital

    Suwon, 443-721

Other trials in South Korea

Mexico2 sites

  • Unidad de Diagnostico Integral

    Colima, 28000

  • Phylasis Clinicas Research S de RL de CV

    Cuautitlán Izcalli, State of Mexico, 54740

Other trials in Mexico

Egypt1 site

  • Ain Shams University Hospital

    Cairo

Other trials in Egypt

Finland1 site

  • Suomen Terveystalo Turku

    Turku, 20100

Other trials in Finland

South Africa1 site

  • Parklands Hospital

    Durban, KwaZulu-Natal

Other trials in South Africa

About this study

Official title: A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).

Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.

Being tested
Fesoterodine 8 mg, Placebo
Keywords
Bladder Overactive, Overactive urinary bladder, Overactive Bladder
Medical subject headings
Urinary Bladder, Overactive

What participants receive

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

  • Fesoterodine 8 mgDrug

    Also called Toviaz

    Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.

  • PlaceboDrug

    Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.

Study groups in NCT01302054
Study groupRoleWhat they receive
FesoterodineExperimentalNot described
Receives: Drug: Fesoterodine 8 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours

    UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

    Measured: Baseline, Week 12

  2. Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12

    UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

    Measured: Baseline, Week 12

Secondary outcomes (9)

  1. Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12

    Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.

    Measured: Baseline, Week 12

  2. Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12

    The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

    Measured: Baseline, Week 12

  3. Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12

    PPBC: single-item, self-administered validated questionnaire. Participant answered: "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale, 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2).

    Measured: Baseline, Week 12

  4. Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12

    UPS: single-item, self-administered validated questionnaire. Participant answered: "Which of the following would typically describe your experience when you have a desire to urinate?" on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).

    Measured: Baseline, Week 12

  5. Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12

    OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Change=observation minus baseline.

    Measured: Baseline, Week 12

  6. Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12

    OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.

    Measured: Baseline, Week 12

  7. Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2

    UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

    Measured: Week -2, Week 12

  8. Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline

    UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

    Measured: Baseline, Week 12

  9. Percentage of Participants With No UUI Episodes (Diary Dry Rate)

    UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

    Measured: Week 4, Week 12

Timeline

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

  1. First posted23 Feb 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
990 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01302054
Sponsor's protocol ID
A0221094
Status last verified
Nov 2018
First submitted
18 Feb 2011
Last updated
4 Dec 2018
Data monitoring committee
Yes

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 37160401

  • Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.

    PubMed 35881009

  • Kaplan SA, Cardozo L, Herschorn S, Grenabo L, Carlsson M, Arumi D, Crook TJ, Whelan L, Scholfield D, Ntanios F; Assessment of Fesoterodine after Tolterodine ER (AFTER) Study Group. Efficacy and safety of fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine ER. Int J Clin Pract. 2014 Sep;68(9):1065-73. doi: 10.1111/ijcp.12464. Epub 2014 Jun 4.

    PubMed 24898471

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fesoterodine 8 mg in people with Urinary Bladder, Overactive, run by Pfizer at 176 sites in 15 countries.

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 3 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, Canada, Germany, Ukraine, Russia and 10 more countries. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 12 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours (time frame: Baseline, 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 NCT01302054, 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 4 Dec 2018.

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