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A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

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ClinicalTrials.gov Identifier: NCT00645281
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: tolterodine extended release Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 896 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-Label, Single-Arm, Non-Randomized, Trial in Adult Patients With OAB.
Study Start Date : March 2004
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: tolterodine ER group Drug: tolterodine extended release
Tolterodine ER capsule 4 mg daily for 12 weeks


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. OAB Bother Rating Scale at baseline [ Time Frame: baseline ]
  2. Change from baseline to Week 4 and 12 in micturition bladder diary variables [ Time Frame: 12 weeks ]
  3. Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition [ Time Frame: 12 weeks ]
  4. Change from baseline to Week 4 and 12 in AUA Symptom Index [ Time Frame: 12 weeks ]
  5. Change from baseline to Week 4 and 12 in OAB questionnaire [ Time Frame: 12 weeks ]
  6. Clinical Global Impression-Improvement at Week 12 [ Time Frame: 12 weeks ]
  7. Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12 [ Time Frame: 12 weeks ]
  8. To asses the safety of tolterodine in patients with OAB [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • self-reported symptoms of OAB for ≥ 3 months prior to screening
  • OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
  • urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
  • patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

Exclusion Criteria:

  • any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
  • any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
  • stress incontinence, functional, or overflow incontinence as determined by the investigator
  • symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to participation in this clinical trial
  • clinically significant urinary tract obstruction
  • history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
  • clinically significant interstitial cystitis or significant bladder pain syndrome
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645281


  Show 96 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00645281     History of Changes
Other Study ID Numbers: A6121001
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008

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