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A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
This study is currently recruiting participants.
Verified by Brigham and Women's Hospital, May 2008
Sponsors and Collaborators: Brigham and Women's Hospital
Pfizer
Information provided by: Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00323635
  Purpose

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

MedlinePlus related topics: Menopause Urinary Incontinence Urine and Urination
Drug Information available for: Tolterodine Tolterodine tartrate
U.S. FDA Resources
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.

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Nocturnal urinary frequency, recorded on an event/symptom chart; [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychological self-reports, scores on anxiety and depression rating scales; [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Quality of life, scores on the Women's Health Questionnaire. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: 2 months ] [ Designated as safety issue: No ]

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323635

Contacts
Contact: Laurel E Dantas, B.S. 617-732-7031 ldantas@partners.org
Contact: Ian C Shempp, B.S. 617-525-7641 ishempp@partners.org

Locations
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    
Sponsors and Collaborators
Brigham and Women's Hospital
Pfizer
Investigators
Principal Investigator: Quentin R Regestein, M.D. Brigham and Women's Hospital
  More Information

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

Keywords provided by Brigham and Women's Hospital:
nocturia
urinary incontinence
overactive bladder
tolterodine
sleep
sleep disorder
menopause
midlife women
psychological tests

Study placed in the following topic categories:
Signs and Symptoms
Urinary Bladder, Overactive
Nocturia
Urologic Diseases
Urination Disorders
Sleep Disorders
Urinary Incontinence
Menopause
Tolterodine

Additional relevant MeSH terms:
Muscarinic Antagonists
Urological Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009