Official Title: “A Cross-Over, Double-Blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: April 2009

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.

Intervention(s) in this Clinical Trial

• Drug: tolterodine
  • tablet, 4 mg, daily, 1 month

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Nocturnal urinary frequency, recorded on an event/symptom chart;
  • Time Frame: 2 months
    Safety Issue?: No

Secondary Measures

• Psychological self-reports, scores on anxiety and depression rating scales;
  • Time Frame: 2 weeks
    Safety Issue?: No
• Quality of life, scores on the Women's Health Questionnaire.
  • Time Frame: 2 weeks
    Safety Issue?: No
• Sleep quality
  • Time Frame: 2 months
    Safety Issue?: No

Inclusion Criteria:

• 1. Post-menopausal women, age 45 to 65 years old.
• 2. No menses for at least 6 months before the study start.
• 3. Have at least 14 episodes of nocturia per week.
• 4. Have at least 4 hot flashes daily.
• 5. Overall good health, as evidenced by a letter from the primary care provider.
• 6. Agree not to use HRT including tolterodine shakes, or nutritional supplements that potentially reduce hot flashes.
• 7. Have discontinued all HRT, systemic, topical, or vaginal, at least 60 days before admission and throughout participation in the study.

Exclusion Criteria:

• 1. Use of anti-cholinergic, hypnotic or sedating drugs
• 2. Presence of urinary retention, gastric retention, chronic severe constipation,or narrow-angled glaucoma.
• 3. A urinary tract infection within a month of study start.
• 4. Undiagnosed abnormal vaginal bleeding.
• 5. Benign or malignant liver disease.
• 6. History or presence of chronic alcoholism or medication addiction within the past 5 yrs.
• 7. An acute systemic infection within seven days before the study start.
• 8. Concurrent participation in another clinical trial and/or receiving an experimental medication/device in the last 30 days before admission to the study.
• 9. History of shift work within the past 6 months.

Exclusion Criteria:

-

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Brigham and Women's Hospital

Overall Clinical Trial Officials and Contacts

Quentin R Regestein, M.D. Principal Investigator Brigham and Women's Hospital  

Overall Contact: Laurel E Dantas, B.S. 617-732-7031 ldantas@partners.org

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00323635

Study ID Number: 2005-P-000960

ClinicalTrials.gov Identifier: NCT00323635

Health Authority: United States: Institutional Review Board