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Trial record 1 of 1 for:    NCT00230789
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Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.

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ClinicalTrials.gov Identifier: NCT00230789
Recruitment Status : Completed
First Posted : October 3, 2005
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE September 29, 2005
First Posted Date  ICMJE October 3, 2005
Last Update Posted Date January 27, 2021
Study Start Date  ICMJE October 2005
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2005)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2013)
  • Percentage of subjects reporting satisfaction (including 'very satisfied' and 'a little satisfied') with their current OAB treatment measured by Patient Perception of Treatment Satisfaction
  • 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
  • Change in mean number of urgency urinary incontinence episodes at weeks 4, 8, 12 and 16 compared with baseline
  • 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).
  • 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
  • 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:
  • Total micturitions: total number of micturition episodes per time period (24 hour or nocturnal)
  • 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
  • Severe OAB micturitions in subjects with severe OAB micturition at baseline: Number of severe OAB micturition episodes per time period (24 hour or nocturnal).
  • Severe OAB micturition episodes defined as number of micturitions associated with a Urinary Sensation Scale rating of greater than or equal to 4
  • Change in Patient Perception of Bladder Condition (PPBC) at weeks 8 and 16 compared with baseline
  • Change in Patient Perception of Urgency Scale (PPUS) at weeks 8 and 16 compared with baseline
  • 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
  • Reasons for treatment withdrawal.
  • Adverse events during the 16 week treatment period
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2005)
Information was omitted due to their commercial sensitivity, and will be revealed at a later date. Percentage of subjects reporting satisfaction (including 'very satisfied' and 'a little satisfied') with their current OAB treatment using the Patient
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE
  • Drug: Tolterodine ER 4 mg QD
  • Behavioral: OAB Patient Behavioral Training Material
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 17, 2007)
417
Original Enrollment  ICMJE
 (submitted: September 29, 2005)
400
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00230789
Other Study ID Numbers  ICMJE A6121146
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP