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Sponsors and Collaborators: |
Brigham and Women's Hospital Pfizer |
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Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00323635 |
This study is being done to compare frequency of urination during the night when women take tolterodine tablets vs. when they take placebo tablets.
We will also measure whether between these two treatment conditions there are any differences in women's sleep, mood and performance on cognitive tests.
Condition | Intervention | Phase |
---|---|---|
Urinary Incontinence |
Drug: tolterodine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Cross-Over, Double-Blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women. |
Estimated Enrollment: | 49 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: tolterodine
tablet, 4 mg, daily, 1 month
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From midlife onwards, about half of women complain of poor sleep quality. One possible reason might be an increased frequency of need to urinate during the night. Women feel more frequent urges to urinate when structures that support the bladder become more lax. Tolterodine is a drug that can raise the threshold for volume of urine that accumulates in the bladder before the urge to urinate arises.
Many factors determine how people say they sleep, such as their sleep as recorded by sleep-measuring instruments, how closely they notice their night's sleep, whether they are generally prone to make positive or negative judgments or to have a lot or a few body symptoms.
In this study, women between ages 45 to 65 who are past the menopause and who are frequently bothered by the need to urinate during the night will take either tolterodine or placebo tablets for 8 weeks. During the last week they will record the hours they slept and the quality of their sleep each morning. They will wear a device on their wrist through the week that continuously records whether they are asleep or awake. During three nights of the week they will record the volume of urine whenever they urinate. At the end of the week they will complete questionnaires about their mood and take some computerized tests that measure their alertness. Thereafter they will repeat these procedures, taking the kind of tablets they did not take during the first 8-week treatment period.
We will compare the frequency of urination, sleep, mood as adjusted for the tendency to make positive or negative judgments and daytime attention level to find if any of these differ between the two treatment periods, and to explain differences between any differences that may be found.
Ages Eligible for Study: | 45 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
-
Contact: Laurel E Dantas, B.S. | 617-732-7031 | ldantas@partners.org |
Contact: Ian C Shempp, B.S. | 617-525-7641 | ishempp@partners.org |
United States, Massachusetts | |
Brigham & Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02120 | |
Principal Investigator: Quentin R Regestein, M.D. | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: May M Wakamatsu, M.D. 617-724-6850 mwakamatsu@partners.org |
Principal Investigator: | Quentin R Regestein, M.D. | Brigham and Women's Hospital |
Responsible Party: | Brigham & Women's Hospital ( Quentin Regestein ) |
Study ID Numbers: | 2005-P-000960 |
Study First Received: | May 5, 2006 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00323635 |
Health Authority: | United States: Institutional Review Board |
nocturia urinary incontinence overactive bladder tolterodine sleep |
sleep disorder menopause midlife women psychological tests |
Signs and Symptoms Urinary Bladder, Overactive Nocturia Urologic Diseases Urination Disorders |
Sleep Disorders Urinary Incontinence Menopause Tolterodine |
Muscarinic Antagonists Urological Manifestations Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Cholinergic Antagonists Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions |