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OpenTrials
Completed

NCT Number: NCT00645281

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tolterodine extended release

Drug

Tolterodine ER capsule 4 mg daily for 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Study completion
2005
First posted
Mar 27, 2008
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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