Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00230789
First received: September 29, 2005
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence
Drug: Tolterodine ER 4 mg QD
Behavioral: OAB Patient Behavioral Training Material
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 417
Study Start Date: October 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230789

  Show 51 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00230789     History of Changes
Other Study ID Numbers: A6121146
Study First Received: September 29, 2005
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Tolterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014