A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.

NCT00323635

Last updated date
Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urinary Incontinence
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 exogenous hormones including soy isoflavones or soybean-based shakes, or nutritional supplements that potentially reduce hot flashes.

7. Have discontinued all hormone treatments, systemic, topical, or vaginal, at least 60 days before admission and throughout participation in the study.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.


-

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
Official Title  ICMJE A Parallel, Double-blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women.
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE Drug: tolterodine
tablet, 4 mg, daily, 1 month
Other Name: Detrol
Study Arms  ICMJE
  • Experimental: Tolterodine
    Tolterodine 4 mg q.d. X 8 weeks
    Intervention: Drug: tolterodine
  • Placebo Comparator: Placebo
    A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
    Intervention: Drug: tolterodine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 1, 2012)
19
Original Enrollment  ICMJE
 (submitted: May 5, 2006)
49
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 exogenous hormones including soy isoflavones or soybean-based shakes, or nutritional supplements that potentially reduce hot flashes.
  7. Have discontinued all hormone treatments, 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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323635
Other Study ID Numbers  ICMJE 2005-P-000960
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quentin Rodney Regestein, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Quentin R Regestein, M.D.Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP