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.

Urinary Bladder, Overactive Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302054
• Other study ID #: A0221094
• Status: Completed
• Phase: Phase 4
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 990
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• Fesoterodine 8 mg
Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.
• Placebo
Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.

Locations

Country	Name	City	State
Bulgaria	MBAL Trimontsium OOD	Plovdiv
Bulgaria	MBAL Ruse AD, Urologichno otdelenie,	Ruse
Bulgaria	MBAL Doverie AD, Otdelenie po urologia	Sofia
Bulgaria	MBALSM N.I.Pirogov EAD	Sofia
Bulgaria	UMBAL Aleksandrovska EAD	Sofia
Canada	The Male/Female Health and Research Centre, Royal Court Medical Centre	Barrie	Ontario
Canada	Maritime Research Center	Bathurst	New Brunswick
Canada	Maritime Research Center	Bathurst	New Brunswick
Canada	The Prostate Cancer Centre	Calgary	Alberta
Canada	Lois Hole Hospital for Women, Royal Alexandra Hospital	Edmonton	Alberta
Canada	Centre for Applied Urological Research, Queen's University, Kingston General Hospital	Kingston	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Diex Research Montreal Inc.	Montreal	Quebec
Canada	URLX Corporation	Ottawa	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Czechia	Prvni privatni chirurgicke centrum spol. s .r.o. - SANUS	Hradec Kralove
Czechia	Nemocnice Jindrichuv Hradec	Jindrichuv Hradec
Czechia	Oblastni nemocnice Kolin, a.s.	Kolin III
Czechia	Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.	Usti nad Labem
Egypt	Ain Shams University Hospital	Cairo
Finland	Suomen Terveystalo Turku	Turku
Germany	Klinische Forschung Berlin	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Praxis fuer Urologie	Berlin
Germany	Duisburger Fachaerztegemeinschaft	Duisburg
Germany	ZKS Suedbrandenburg GmbH	Elsterwerda
Germany	Facharzt für Frauenheilkunde und Geburtshilfe	Frankfurt am Main
Germany	Urologische Praxis	Hagenow
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	Arztpraxis Dr. von Keitz	Marburg
Germany	Pharmakologisches Studienzentrum Chemnitz GmbH	Mittweida
Germany	Frauenarzt Praxis	Muenchen
Hungary	Semmelweis Egyetem Altalanos Orvostudomanyi Kar Urologiai Klinika	Budapest
Hungary	Soproni Erzsebet Oktato Korhaz, Urologiai Osztaly	Sopron
Hungary	Donatella 99 Bt.	Szentes
Hungary	MAV Korhaz es Rendelointezet, Urologia	Szolnok
Korea, Republic of	Department of Urology, Pusan National University Hospital	Pusan
Korea, Republic of	Department of Urology, Konkuk University Medical Center	Seoul
Korea, Republic of	Department of Urology, Ajou University Hospital	Suwon
Mexico	Unidad de Diagnostico Integral	Colima
Mexico	Phylasis Clinicas Research S de RL de CV	Cuautitlan Izcalli	Estado De Mexico
Poland	NZOZ VIP - MED, Poradnia Urologiczna	Gdynia
Poland	SP ZOZ Wojewodzki Szpital Specjalistyczny im. J. Koraczaka	Slupsk
Poland	Specjalistyczny Gabinet Lekarski	Warszawa
Russian Federation	Kemerov? Regional Perinatal Center	Kemerovo
Russian Federation	Moscow State Healthcare Institution City Clinical Hospital #12	Moscow
Russian Federation	Saint-Petersburg State Budgetary Healthcare Institution City Hospital #26	Saint-Petersburg
Russian Federation	Saint-Petersburg State Healthcare Institution City Hospital # 15	Saint-Petersburg
Russian Federation	Saint-Petersburg State Medical University I.P.Pavlov	Saint-Petersburg
Russian Federation	St. Petersburg State Healthcare Institution	St. Petersburg
Russian Federation	Siberian State Medical University	Tomsk
South Africa	Parklands Hospital	Durban	Kwa Zulu Natal
Sweden	Kvinnohalsan Soder	Bandhagen
Sweden	Me3plus Clinical Trials	Goteborg
Sweden	Partus Kvinnohalsa	Goteborg
Sweden	Specialistmottagningen i urologi	Goteborg
Sweden	Tudorkliniken, Specialistmottagningen i Urologi	Halmstad
Sweden	Vrinnevisjukhuset	Norrkoping
Ukraine	Regional Clinical Hospital, Department of Urology of Dnipropetrovsk State Medical Academy	Dnipropetrovsk
Ukraine	Regional Clinical Center of Urology and Nephrology	Kharkiv
Ukraine	Institute of Urology of AMS of Ukraine	Kyiv
Ukraine	Lugansk City Multi-Discipline Hospital #2, department of Urology	Lugansk
Ukraine	5Th City Clinical Hospital, Urology Department	Lviv
Ukraine	LTD Out-patient clinic of General practice and Family medicine	Odesa
Ukraine	Poltava Regional Clinical Hospital, Department of Urology	Poltava
Ukraine	Municipal Institution of Ternopil Regional Council, Ternopil University Hospital	Ternopil
United States	Radiant Research, Inc.	Akron	Ohio
United States	Northeast Urogynecology	Albany	New York
United States	The Urologic Institute of Northeastern New York - Community Care Physicians, PC	Albany	New York
United States	Atlanta Medical Research Institute, LLC	Alpharetta	Georgia
United States	Radiant Research, Inc.	Anderson	South Carolina
United States	Integra Trials, LLC	Arlington	Virginia
United States	Washington Urology	Arlington	Virginia
United States	Radiant Research, Inc.	Atlanta	Georgia
United States	Fox Valley Clinical Research Center, LLC	Aurora	Illinois
United States	Adult Care of Austin	Austin	Texas
United States	Senior Adults Specialty Research	Austin	Texas
United States	Urologic Consultants of Southeastern Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Beaumont Internal Medicine & Geriatric Associates	Beaumont	Texas
United States	DiscoveResearch, Inc.	Beaumont	Texas
United States	Alabama Internal Medicine, PC	Birmingham	Alabama
United States	Radiant Research, Inc.	Birmingham	Alabama
United States	Manatee Medical Research Institute, LLC	Bradenton	Florida
United States	DiscoveResearch, Inc.	Bryan	Texas
United States	DiscoveResearch, Incorporated	Bryan	Texas
United States	PMG Research of Raleigh, LLC d/b/a PMG Research of Cary	Cary	North Carolina
United States	Radiant Research, Inc.	Chandler	Arizona
United States	PMG Research of Charlotte	Charlotte	North Carolina
United States	Urology Specialists of the Carolinas	Charlotte	North Carolina
United States	Chattanooga Medical Research, LLC	Chattanooga	Tennessee
United States	OB-GYN Centre of Excellence	Chattanooga	Tennessee
United States	Radiant Research, Inc.	Chicago	Illinois
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Columbia Women's Healthcare, LLC	Columbia	South Carolina
United States	SC Clinical Research Center, LLC	Columbia	South Carolina
United States	Radiant Research, Inc.	Columbus	Ohio
United States	Radiant Research, Inc.	Dallas	Texas
United States	Providence Health Partners - Center for Clinical Research	Dayton	Ohio
United States	Atlantic Institute of Clinical Research	Daytona Beach	Florida
United States	SJS Clinical Research	Destin	Florida
United States	In-Quest Medical Research, LLC	Duluth	Georgia
United States	Gilbert Teixeira, DO	East Providence	Rhode Island
United States	Pharma Resource	East Providence	Rhode Island
United States	Radiant Research, Inc.	Edina	Minnesota
United States	OB/GYN Associates of Erie	Erie	Pennsylvania
United States	Pacific Women's Center, LLC	Eugene	Oregon
United States	Brown and McCool Gynecology	Fairhope	Alabama
United States	New England Center for Clinical Research Fall River, LLC	Fall River	Massachusetts
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Eclipse Clinical Research	Green Valley	Arizona
United States	Radiant Research, Inc.	Greer	South Carolina
United States	Thameside Obstetrics/Gynecological Center	Groton	Connecticut
United States	S.H.E. Medical Associates	Hartford	Connecticut
United States	Advances In Health, Inc.	Houston	Texas
United States	Centex Research, Inc. - Pineloch Medical Clinic	Houston	Texas
United States	The Office of Dr. Steven Maislos, MD	Houston	Texas
United States	CRC of Jackson	Jackson	Mississippi
United States	Women's Specialty Center	Jackson	Mississippi
United States	Advanced Therapeutics, Inc.	Johnson City	Tennessee
United States	Johnson City Internal Medicine	Johnson City	Tennessee
United States	Beyer Research	Kalamazoo	Michigan
United States	Francis Jimenez, MD	Las Vegas	Nevada
United States	Impact Clinical Trials	Las Vegas	Nevada
United States	Richard M. Groom, MD	Las Vegas	Nevada
United States	American Institute of Research	Los Angeles	California
United States	Institute for Advanced Urology	Los Angeles	California
United States	Moaz Khorsandi, DO	Los Angeles	California
United States	Urology Group of Southern California	Los Angeles	California
United States	PMG Research of Charleston, LLC	Mount Pleasant	South Carolina
United States	Integrity Medical Research, LLC	Mountlake Terrace	Washington
United States	Urology Northwest, PA	Mountlake Terrace	Washington
United States	Radiant Research, Inc.	Murray	Utah
United States	New England Center for Clinical Research of Massachusetts, LLC	New Bedford	Massachusetts
United States	University Urology Associates	New York	New York
United States	Urology of Indiana, LLC	Noblesville	Indiana
United States	Central Sooner Research	Norman	Oklahoma
United States	Ocala Urology Specialists	Ocala	Florida
United States	Renstar Medical Research, Inc.	Ocala	Florida
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Associated Medical Professionals of New York, PLLC	Oneida	New York
United States	Radiant Research, Inc.	Overland Park	Kansas
United States	Center for Clinical Trials, LLC	Paramount	California
United States	Advanced Urology, PC	Parker	Colorado
United States	Memorial Hospital of Rhode Island - Clinical Studies Center	Pawtucket	Rhode Island
United States	Research Protocol Management Specialists	Pittsburgh	Pennsylvania
United States	Village Health Partners	Plano	Texas
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	Prism Research Group	Rome	Georgia
United States	Valley Health Care	Rome	Georgia
United States	Sierra Clinical Research	Roseville	California
United States	Superior Research LLC	Sacramento	California
United States	Radiant Research, Inc.	Saint Louis	Missouri
United States	Pinellas Urology, Inc.	Saint Petersburg	Florida
United States	PMG Research of Salisbury, LLC	Salisbury	North Carolina
United States	Salibury Urological Clinic	Salisbury	North Carolina
United States	Paragon Research Center, LLC	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Adult and Pediatric Urology	Sartell	Minnesota
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	The Urology Group	Southaven	Mississippi
United States	North Spokane Women's Clinic	Spokane	Washington
United States	Associated Medical Professionals of NY	Syracuse	New York
United States	Florida Urology Partners	Tampa	Florida
United States	Medical Research Associates, Inc.	Traverse City	Michigan
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Urological Associates of Southern Arizona, PC	Tucson	Arizona
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	The Office of Georgis Patsias, MD, PA	Wellington	Florida
United States	Advanced Clinical Research	West Jordan	Utah
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Carolina Urological Associates	Winston-Salem	North Carolina
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Egypt,  Finland,  Germany,  Hungary,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  South Africa,  Sweden,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 12
Primary	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.	Baseline, Week 12
Secondary	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.	Baseline, Week 12
Secondary	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.	Baseline, Week 12
Secondary	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).	Baseline, Week 12
Secondary	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).	Baseline, Week 12
Secondary	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.	Baseline, Week 12
Secondary	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.	Baseline, Week 12
Secondary	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.	Week -2, Week 12
Secondary	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.	Baseline, Week 12
Secondary	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.	Week 4, Week 12

External Links

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