Clinical trial NCT00323635: A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
Official title: A Parallel, Double-blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Urinary Incontinence
Keywords: nocturia
urinary incontinence
overactive bladder
tolterodine
sleep
sleep disorder
menopause
midlife women
psychological tests
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-05-09
Enrollment: 19
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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.

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Primary outcomes:
measure: Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart;
timeFrame: 2 months
measure: Urgency
timeFrame: Beginning after the first void on the Friday morning of week 7 and week 13 of their participation;
measure: Number of Incontinence Episodes;
timeFrame: Duration of Study
measure: Relationship of Incontinence to Urge or Stress
timeFrame: Duration of study
Secondary outcomes:
measure: Psychological Self-reports, Scores on Anxiety and Depression Rating Scales;
timeFrame: 2 weeks
measure: Quality of Life, Scores on the Women's Health Questionnaire.
timeFrame: 2 weeks
measure: Sleep Quality
timeFrame: 2 months
measure: Cognitive Function
timeFrame: Two 20-minute sessions during 2 months
measure: Hyperarousal
timeFrame: At baseline and 8 weeks later
measure: Whether She Used Any Pads.
timeFrame: Duration of Study
measure: Pads Used
timeFrame: Duration of Study
Other outcomes:
measure: Sleep / Wake Pattern
timeFrame: Two weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Quentin R Regestein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shaver JL, Paulsen VM. Sleep, psychological distress, and somatic symptoms in perimenopausal women. Fam Pract Res J. 1993 Dec;13(4):373-84.
citation: Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep. 2003 May 1;26(3):342-92. doi: 10.1093/sleep/26.3.342.
citation: Brooks JO 3rd, Friedman L, Bliwise DL, Yesavage JA. Use of the wrist actigraph to study insomnia in older adults. Sleep. 1993 Feb;16(2):151-5. doi: 10.1093/sleep/16.2.151.