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AzTrials

Overactive BladderPhase 3NCT00611026

Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

A Phase 3 study testing Tolterodine ER and Fesoterodine in people with Overactive Bladder, run by Pfizer at 227 sites in 25 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

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder
What is being tested?
Tolterodine ER and Fesoterodine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,417 participants
Where
227 sitesin 25 countries
Study dates
Feb 2008to Oct 2009
Phase
Phase 3
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

  • Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
  • Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
  • Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Who cannot join

  • Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
  • Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
  • OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
  • Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.

Trial locations and contacts

227 sites in 25 countries.

227 sites in 25 countries

United States102 sites

  • Pfizer Investigational Site

    Anaheim, California, 92801

  • Pfizer Investigational Site

    Anderson, South Carolina, 29621

  • Pfizer Investigational Site

    Ann Arbor, Michigan, 48103

  • Pfizer Investigational Site

    Arlington, Virginia, 22205

  • Pfizer Investigational Site

    Atlanta, Georgia, 30308

  • Pfizer Investigational Site

    Atlanta, Georgia, 30342

  • Pfizer Investigational Site

    Avon, Indiana, 46123

  • Pfizer Investigational Site

    Baltimore, Maryland, 21211

  • Pfizer Investigational Site

    Beaumont, Texas, 77701

  • Pfizer Investigational Site

    Beaumont, Texas, 77706

  • Pfizer Investigational Site

    Bel Air, Maryland, 21014

  • Pfizer Investigational Site

    Bensalem, Pennsylvania, 19020

  • Pfizer Investigational Site

    Bonita Spring, Florida, 34134

  • Pfizer Investigational Site

    Bryan, Texas, 77802

  • Pfizer Investigational Site

    Cary, North Carolina, 27518

  • Pfizer Investigational Site

    Chandler, Arizona, 85225

  • Pfizer Investigational Site

    Charlottesville, Virginia, 22911

  • Pfizer Investigational Site

    Chicago, Illinois, 60654

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45212

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45249

  • Pfizer Investigational Site

    Clovis, California, 93611

  • Pfizer Investigational Site

    Cumberland, Rhode Island, 02864

  • Pfizer Investigational Site

    Edina, Minnesota, 55435

  • Pfizer Investigational Site

    Englewood, Colorado, 80112

  • Pfizer Investigational Site

    Enterprise, Alabama, 36330

  • Pfizer Investigational Site

    Evansville, Indiana, 47714

  • Pfizer Investigational Site

    Fresno, California, 93710

  • Pfizer Investigational Site

    Fresno, California, 93720

  • Pfizer Investigational Site

    Greer, South Carolina, 29651

  • Pfizer Investigational Site

    Hamilton, New Jersey, 08690

  • Pfizer Investigational Site

    Hollywood, Florida, 33021

  • Pfizer Investigational Site

    Jacksonville, Florida, 32205

  • Pfizer Investigational Site

    Jacksonville, Florida, 32216

  • Pfizer Investigational Site

    Johnson City, Tennessee, 37601

  • Pfizer Investigational Site

    Kansas City, Missouri, 64114

  • Pfizer Investigational Site

    Lake Worth, Florida, 33461

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89148

  • Pfizer Investigational Site

    Leesburg, Florida, 34748

  • Pfizer Investigational Site

    Lexington, Kentucky, 40504

  • Pfizer Investigational Site

    Lexington, Kentucky, 40509

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68506

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68510

  • Pfizer Investigational Site

    Little Rock, Arkansas, 72205

  • Pfizer Investigational Site

    Longwood, Florida, 32779

  • Pfizer Investigational Site

    Louisville, Kentucky, 40207

  • Pfizer Investigational Site

    Louisville, Kentucky, 40291

  • Pfizer Investigational Site

    Loxahatchee Groves, Florida, 33470

  • Pfizer Investigational Site

    Meridian, Idaho, 83642

  • Pfizer Investigational Site

    Metairie, Louisiana, 70002

  • Pfizer Investigational Site

    Miami, Florida, 33143

  • Pfizer Investigational Site

    Miami, Florida, 33186

  • Pfizer Investigational Site

    Midvale, Utah, 84047

  • Pfizer Investigational Site

    Mobile, Alabama, 36608

  • Pfizer Investigational Site

    Montgomery, Alabama, 36117

  • Pfizer Investigational Site

    Naples, Florida, 34102

  • Pfizer Investigational Site

    Nashville, Tennessee, 37203

  • Pfizer Investigational Site

    New London, Connecticut, 06320

  • Pfizer Investigational Site

    New Tazewell, Tennessee, 37825

  • Pfizer Investigational Site

    Noblesville, Indiana, 46158

  • Pfizer Investigational Site

    North Dartmouth, Massachusetts, 02747

  • Pfizer Investigational Site

    Olive Branch, Mississippi, 38654

  • Pfizer Investigational Site

    Omaha, Nebraska, 68134

  • Pfizer Investigational Site

    Overland Park, Kansas, 66210

  • Pfizer Investigational Site

    Overland Park, Kansas, 66215

  • Pfizer Investigational Site

    Pawtucket, Rhode Island, 02860

  • Pfizer Investigational Site

    Pembroke Pines, Florida, 33024

  • Pfizer Investigational Site

    Peoria, Arizona, 85381

  • Pfizer Investigational Site

    Peoria, Illinois, 61614

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19114

  • Pfizer Investigational Site

    Picayune, Mississippi, 39466

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15243

  • Pfizer Investigational Site

    Plano, Texas, 75024

  • Pfizer Investigational Site

    Plano, Texas, 75093

  • Pfizer Investigational Site

    Raleigh, North Carolina, 27609

  • Pfizer Investigational Site

    Raleigh, North Carolina, 27612

  • Pfizer Investigational Site

    Richmond, Virginia, 23294

  • Pfizer Investigational Site

    Royal Oak, Michigan, 48073

  • Pfizer Investigational Site

    San Antonio, Texas, 78229

  • Pfizer Investigational Site

    San Diego, California, 92103

  • Pfizer Investigational Site

    Sartell, Minnesota, 56377

  • Pfizer Investigational Site

    Seattle, Washington, 98104

  • Pfizer Investigational Site

    Seattle, Washington, 98166

  • Pfizer Investigational Site

    Spokane, Washington, 99207

  • Pfizer Investigational Site

    St Louis, Missouri, 63117

  • Pfizer Investigational Site

    Stuart, Florida, 34996

  • Pfizer Investigational Site

    Sugar Land, Texas, 77479

  • Pfizer Investigational Site

    Summerville, South Carolina, 29485

  • Pfizer Investigational Site

    Tallahassee, Florida, 32308

  • Pfizer Investigational Site

    Torrance, California, 90505

  • Pfizer Investigational Site

    Troy, Michigan, 48098

  • Pfizer Investigational Site

    Tucson, Arizona, 85741

  • Pfizer Investigational Site

    Uniontown, Pennsylvania, 15401

  • Pfizer Investigational Site

    Upland, California, 91786

  • Pfizer Investigational Site

    Virginia Beach, Virginia, 23455

  • Pfizer Investigational Site

    Virginia Beach, Virginia, 23464

  • Pfizer Investigational Site

    Vista, California, 92083

  • Pfizer Investigational Site

    Weber City, Virginia, 24290

  • Pfizer Investigational Site

    West Jordan, Utah, 84088

  • Pfizer Investigational Site

    West Palm Beach, Florida, 33409

  • Pfizer Investigational Site

    Westlake Village, California, 91361

  • Pfizer Investigational Site

    Williamsville, New York, 14221

  • Pfizer Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Russia11 sites

  • Pfizer Investigational Site

    Moscow, 101000

  • Pfizer Investigational Site

    Moscow, 105425

  • Pfizer Investigational Site

    Moscow, 109388

  • Pfizer Investigational Site

    Moscow, 115516

  • Pfizer Investigational Site

    Moscow, 117997

  • Pfizer Investigational Site

    Moscow, 119991

  • Pfizer Investigational Site

    Rostov-on-Don, 344022

  • Pfizer Investigational Site

    Saint Petersburg, 190013

  • Pfizer Investigational Site

    Saint Petersburg, 196247

  • Pfizer Investigational Site

    Saint Petersburg, 197022

  • Pfizer Investigational Site

    Saint Petersburg, 199106

Other trials in Russia

Canada10 sites

  • Pfizer Investigational Site

    Chicoutimi, Quebec, G7H 4A3

  • Pfizer Investigational Site

    Halifax, Nova Scotia, B3H 3A7

  • Pfizer Investigational Site

    Montreal, Quebec, H1T 2M4

  • Pfizer Investigational Site

    Montreal, Quebec, H2X 1N8

  • Pfizer Investigational Site

    Montreal, Quebec, H2X 3J4

  • Pfizer Investigational Site

    Oshawa, Ontario, L1H 7K4

  • Pfizer Investigational Site

    Saskatoon, Saskatchewan, S7K 1N8

  • Pfizer Investigational Site

    Surrey, British Columbia, V3V 1N1

  • Pfizer Investigational Site

    Trois-Rivières, Quebec, G9A 3V7

  • Pfizer Investigational Site

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Germany10 sites

  • Pfizer Investigational Site

    Berlin, 10629

  • Pfizer Investigational Site

    Berlin, 10787

  • Pfizer Investigational Site

    Grünstadt, 67269

  • Pfizer Investigational Site

    Hamburg, 20253

  • Pfizer Investigational Site

    Krumbach, 86381

  • Pfizer Investigational Site

    Leipzig, 04103

  • Pfizer Investigational Site

    Marburg, 35039

  • Pfizer Investigational Site

    Muelheim A.d. Ruhr, 45468

  • Pfizer Investigational Site

    München, 81241

  • Pfizer Investigational Site

    München, 81925

Other trials in Germany

South Africa8 sites

  • Pfizer Investigational Site

    Bloemfontein, Free State, 9301

  • Pfizer Investigational Site

    Claremont, Cape Town, 8001

  • Pfizer Investigational Site

    Durban, KwaZulu-Natal, 4001

  • Pfizer Investigational Site

    Durban, KwaZulu-Natal

  • Pfizer Investigational Site

    Pietermaritzburg, KwaZulu-Natal, 3201

  • Pfizer Investigational Site

    Pretoria, 0083

  • Pfizer Investigational Site

    Roodepoort, 1715

  • Pfizer Investigational Site

    Vosloorus, Gauteng, 1475

Other trials in South Africa

Poland7 sites

  • Pfizer Investigational Site

    Bialystok, 15-276

  • Pfizer Investigational Site

    Bydgoszcz, 85-094

  • Pfizer Investigational Site

    Gdynia, 81-366

  • Pfizer Investigational Site

    Krakow, 30-017

  • Pfizer Investigational Site

    Lublin, 20-954

  • Pfizer Investigational Site

    Poznan, 61-251

  • Pfizer Investigational Site

    Słupsk, 76-200

Other trials in Poland

Brazil6 sites

  • Pfizer Investigational Site

    Curitiba, Paraná, 80030-220

  • Pfizer Investigational Site

    Goiânia, Goiás, 74175-080

  • Pfizer Investigational Site

    Porto Alegre, Rio Grande do Sul, 90470-340

  • Pfizer Investigational Site

    Rio de Janeiro, Rio de Janeiro, CEP 20551-030

  • Pfizer Investigational Site

    Salvador, Estado de Bahia, 40420-000

  • Pfizer Investigational Site

    São Paulo, São Paulo, 04025-001

Other trials in Brazil

Bulgaria6 sites

  • Pfizer Investigational Site

    Pernik, 2300

  • Pfizer Investigational Site

    Pleven, 5800

  • Pfizer Investigational Site

    Plovdiv, 4002

  • Pfizer Investigational Site

    Plovdiv, 4003

  • Pfizer Investigational Site

    Sofia, 1606

  • Pfizer Investigational Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

India6 sites

  • Pfizer Investigational Site

    Ahmedabad, Gujarat, 380 009

  • Pfizer Investigational Site

    Bengaluru, Karnataka, 560 010

  • Pfizer Investigational Site

    Hyderabad, Andhra Pradesh, 500 001

  • Pfizer Investigational Site

    Nadiād, Gujarat, 387 001

  • Pfizer Investigational Site

    New Delhi, 110001

  • Pfizer Investigational Site

    Pune, Maharashtra, 411 053

Other trials in India

South Korea6 sites

  • Pfizer Investigational Site

    Busan, 602-715

  • Pfizer Investigational Site

    Daegu, 700-721

  • Pfizer Investigational Site

    Incheon, 405-760

  • Pfizer Investigational Site

    Jeonju, Jeollabuk-do, 561-712

  • Pfizer Investigational Site

    Seoul, 134-791

  • Pfizer Investigational Site

    Suwon, 443-721

Other trials in South Korea

Spain6 sites

  • Pfizer Investigational Site

    Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35010

  • Pfizer Investigational Site

    Madrid, Madrid, 28040

  • Pfizer Investigational Site

    San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320

  • Pfizer Investigational Site

    Santander, Cantabria, 39008

  • Pfizer Investigational Site

    Valencia, Valencia, 46009

  • Pfizer Investigational Site

    Valencia, Valencia, 46017

Other trials in Spain

Sweden6 sites

  • Pfizer Investigational Site

    Karlskoga, 691 81

  • Pfizer Investigational Site

    Malmö, 211 52

  • Pfizer Investigational Site

    Norrköping, 601 82

  • Pfizer Investigational Site

    Örebro, 701 46

  • Pfizer Investigational Site

    Skövde, 541 85

  • Pfizer Investigational Site

    Stockholm

Other trials in Sweden

Greece5 sites

  • Pfizer Investigational Site

    Alexandroupoli, 68100

  • Pfizer Investigational Site

    Athens, Maroussi, 14126

  • Pfizer Investigational Site

    Heraklion/Voutes, Crete, 71001

  • Pfizer Investigational Site

    Larissa, 41110

  • Pfizer Investigational Site

    Thessaloniki, 546 35

Other trials in Greece

Hungary5 sites

  • Pfizer Investigational Site

    Debrecen, 4043

  • Pfizer Investigational Site

    Győr, 9023

  • Pfizer Investigational Site

    Nyíregyháza, 4400

  • Pfizer Investigational Site

    Salgótarján, 3100

  • Pfizer Investigational Site

    Szentes, 6600

Other trials in Hungary

Lithuania5 sites

  • Pfizer Investigational Site

    Kaunas, 49476

  • Pfizer Investigational Site

    Kaunas, 50425

  • Pfizer Investigational Site

    Klaipėda, 94231

  • Pfizer Investigational Site

    Vilnius, 01118

  • Pfizer Investigational Site

    Vilnius, 10207

Other trials in Lithuania

Slovakia5 sites

  • Pfizer Investigational Site

    Nitra, 949 01

  • Pfizer Investigational Site

    Považská Bystrica, 017 01

  • Pfizer Investigational Site

    Prešov, 080 01

  • Pfizer Investigational Site

    Trenčín, 911 01

  • Pfizer Investigational Site

    Zvolen, 960 01

Other trials in Slovakia

Ukraine5 sites

  • Pfizer Investigational Site

    Chernivtsi, 58002

  • Pfizer Investigational Site

    Dnipropetrovsk, 49005

  • Pfizer Investigational Site

    Kyiv, 04053

  • Pfizer Investigational Site

    Uzhhorod, 88000

  • Pfizer Investigational Site

    Zaporizhzhya, 69000

Other trials in Ukraine

Romania4 sites

  • Pfizer Investigational Site

    Arad, 310175

  • Pfizer Investigational Site

    Bucharest, Bucharest, 041345

  • Pfizer Investigational Site

    Bucharest, Sector 5,, 050653

  • Pfizer Investigational Site

    Sibiu, Sibiu County, 550245

Other trials in Romania

Costa Rica3 sites

  • Pfizer Investigational Site

    Alajuela, Alajuela Province

  • Pfizer Investigational Site

    Cartago, Cartago Province

  • Pfizer Investigational Site

    San José, Provincia de San José

Other trials in Costa Rica

Estonia3 sites

  • Pfizer Investigational Site

    Tallinn, 10138

  • Pfizer Investigational Site

    Tallinn, 10611

  • Pfizer Investigational Site

    Tartu, 51014

Other trials in Estonia

Colombia2 sites

  • Pfizer Investigational Site

    Barranquilla, Atlántico, 0

  • Pfizer Investigational Site

    Bogotá, Colombia

Other trials in Colombia

Ireland2 sites

  • Pfizer Investigational Site

    Beaumont, Dublin, 9

  • Pfizer Investigational Site

    Dublin, 9

Other trials in Ireland

Malaysia2 sites

  • Pfizer Investigational Site

    Kuala Lumpur, 50586

  • Pfizer Investigational Site

    Kuala Lumpur, 59100

Other trials in Malaysia

Latvia1 site

  • Pfizer Investigational Site

    Riga, LV 1002

Other trials in Latvia

Singapore1 site

  • Pfizer Investigational Site

    Singapore, Singapore, 229899

Other trials in Singapore

About this study

Official title: 12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

Being tested
Tolterodine ER, Placebo, Fesoterodine
Keywords
Treatment of 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.

  • Tolterodine ERDrug

    The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.

  • PlaceboDrug

    Placebo treatment will be once daily(QD) for 12 weeks.

  • FesoterodineDrug

    The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.

Study groups in NCT00611026
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: Tolterodine ER
2Placebo comparatorNot described
Receives: Drug: Placebo
3ExperimentalNot described
Receives: Drug: Fesoterodine

What is being measured

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

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

    UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

    Measured: Baseline, Week 12

Secondary outcomes (18)

  1. Change From Baseline in Mean Voided Volume Per Micturition

    Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.

    Measured: Baseline, Week 1, Week 4, Week 12

  2. Change From Baseline in Mean Number of Micturitions Per 24 Hours

    The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.

    Measured: Baseline, Week 1, Week 4, Week 12

  3. Percent Change From Baseline of Micturitions Per 24 Hours

    Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).

    Measured: Baseline, Week 1, Week 4, Week 12

  4. Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours

    Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.

    Measured: Baseline, Week 1, Week 4, Week 12

  5. Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours

    Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.

    Measured: Baseline, Week 1, Week 4, Week 12

  6. Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4

    UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

    Measured: Baseline, Week 1, Week 4

  7. Percent Change From Baseline of UUI Episodes Per 24 Hours

    UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is

    1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.

    Measured: Baseline, Week 1, Week 4, Week 12

  8. Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)

    Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

    Measured: Baseline, Week 1, Week 4, Week 12

  9. Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)

    Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.

    Measured: Baseline, Week 1, Week 4, Week 12

  10. Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours

    Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

    Measured: Baseline, Week 1, Week 4, Week 12

  11. Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours

    Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

    Measured: Baseline, Week 1, Week 4, Week 12

  12. Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.

    Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

    Measured: Baseline, Week 1, Week 4, Week 12

  13. Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)

    Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

    Measured: Baseline, Week 1, Week 4, Week 12

  14. Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary

    Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

    Measured: Week 1, Week 4, Week 12

  15. Change From Baseline in Patient Perception of Bladder Condition (PPBC)

    Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.

    Measured: Baseline, Week 1, Week, 4, Week 12

  16. Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.

    Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.

    Measured: Baseline, Week 1, Week, 4, Week 12

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

    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. Negative change in Symptom Bother Score indicates improvement.

    Measured: Baseline, Week 12

  18. Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12

    HRQL domain and total raw score derived as sum of scores (6-point scale:

    1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement.

    Measured: Baseline, 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 posted8 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionOct 2009
  4. Study completionOct 2009

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,417 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00611026
Sponsor's protocol ID
A0221046
Status last verified
Jan 2011
First submitted
28 Jan 2008
Last updated
2 Feb 2011
Data monitoring committee
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 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tolterodine ER and Fesoterodine in people with Overactive Bladder, run by Pfizer at 227 sites in 25 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 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 2 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in United States, Russia, Canada, Germany, South Africa and 20 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Jan 2011). 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?

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (time frame: Baseline, Week 12). 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 NCT00611026, which also lists 2 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 2 Feb 2011.

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Clinical Trial NCT00611026 | AzTrials