Clinical trial NCT00230789: Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.
Official title: A Multicenter, Multiphase, Single Arm, Open Label Study To Evaluate The Effects Of Tolterodine ER In Conjunction With Behavioral Intervention On Subject Satisfaction And Over- Active Bladder Symptoms (Urgency Urinary Incontinence (UUI), Urgency, Frequency) In Overactive Bladder Subjects Who Were Dissatisfied With Their Most Recent Antimuscarinic OAB Medication Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-03
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of tolterodine ER in conjunction with behavioral intervention on subject satisfaction in OAB subjects who were dissatisfied with their most recent antimuscarinic OAB medication therapy.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects greater than or equal to 18 years of age
* Overactive bladder symptoms for at least 3 months
* Previously treated with antimuscarinic OAB medications

Exclusion Criteria:

* Participation in any professionally coached sessions (RN, NP, PA or PT) teaching behavioral interventions

Primary outcomes:
measure: Subject satisfaction with treatment at week 16: Percentage of subjects reporting satisfaction with their current OAB treatment using the Patient Perception of Treatment Satisfaction Question
Secondary outcomes:
measure: Percentage of subjects reporting satisfaction (including 'very satisfied' and 'a little satisfied') with their current OAB treatment measured by Patient Perception of Treatment Satisfaction
measure: Percent subjects changed dissatisfied(including'very dissatisfied'and'a little dissatisfied')with OAB week 8 to satisfied(including'very satisfied' and'a little satisfied')with OAB week 16 measured by Patient Perception of Treatment Satisfaction Question
measure: Change in mean number of urgency urinary incontinence episodes at weeks 4, 8, 12 and 16 compared with baseline
measure: Change in mean number of urgency episodes per day at weeks 4, 8, 12 and 16 compared with baseline (Urgency episode defined as micturition episodes associated with Urinary Sensation Scale rating of greater than or equal to 3).
measure: Change in daily urgency micturition rating at weeks 4,8,12 and 16 compared with baseline:Change in mean and sum of Urinary Sensation Scale rating per day
measure: Change in mean number of micturition episodes per 24 hour period and per nocturnal period at weeks 4, 8, 12 and 16 compared with baseline. Means will be based on five dairy days. The following micturition episode parameters will be assessed:
measure: Total micturitions: total number of micturition episodes per time period (24 hour or nocturnal)
measure: OAB micturition: Number of OAB mictruition episodes per time period (24 hour or nocturnal). OAB micturition defined as number of micturition episodes associated with Urinary Sensation Scale ratting of greater than or equal to 3
measure: Severe OAB micturitions in subjects with severe OAB micturition at baseline: Number of severe OAB micturition episodes per time period (24 hour or nocturnal).
measure: Severe OAB micturition episodes defined as number of micturitions associated with a Urinary Sensation Scale rating of greater than or equal to 4
measure: Change in Patient Perception of Bladder Condition (PPBC) at weeks 8 and 16 compared with baseline
measure: Change in Patient Perception of Urgency Scale (PPUS) at weeks 8 and 16 compared with baseline
measure: Change in total Health Related Quality of Life (HRQoL) for Overactive Bladder Questionnaire (OAB-q) and change in scores for each individual domain (symptom bother, coping, concern, sleep, and social function) at weeks 8 and 16 compared with baseline
measure: Reasons for treatment withdrawal.
measure: Adverse events during the 16 week treatment period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sun Lakes
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Buena Park
country: United States
facility: Pfizer Investigational Site
state: California
city: Mission Viejo
country: United States
facility: Pfizer Investigational Site
state: California
city: Modesto
country: United States
facility: Pfizer Investigational Site
state: California
city: Oceanside
country: United States
facility: Pfizer Investigational Site
state: California
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Hallandale Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Wellington
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Woodstock
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Libertyville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Mattoon
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Newton
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Manchester
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Westhampton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Endwell
country: United States
facility: Pfizer Investigational Site
state: New York
city: Garden City
country: United States
facility: Pfizer Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Pfizer Investigational Site
state: New York
city: Greensboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Zanesville
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Norman
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Abington
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bala-Cynwyd
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Camp Hill
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Williamsport
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bartlett
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: New Tazewell
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Provo
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Mountlake Terrace
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: