Urinary Incontinence
Conditions
Keywords
nocturia, urinary incontinence, overactive bladder, tolterodine, sleep, sleep disorder, menopause, midlife women, psychological tests
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.
Interventions
DRUGtolterodine
tablet, 4 mg, daily, 1 month
Sponsors
Pfizer
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Incontinence Episodes; | Duration of Study | Number |
| Relationship of Incontinence to Urge or Stress | Duration of study | 4-grade scale |
| Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart; | 2 months | Subjects note: 1. Number of nocturnal and diurnal voids; 2) level of urgency for 7 days, graded 1 to 4, beginning after the first void on the Friday morning of week 7 and week 13 of their participation; 3) Number of incontinence episodes; 4) Relationship of incontinence to urge or stress (4 grade scale); 4) Whether she used any pads. |
| Urgency | Beginning after the first void on the Friday morning of week 7 and week 13 of their participation; | Level of urgency for 7 days, graded 1 to 4, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function | Two 20-minute sessions during 2 months | Motor speed (number of finger taps in 30 seconds); Continuous Performance (mean response time elicited by appearance of target alphabet letter presented in a series of letters on a monitor screen for 1 minute); Color-Word Stroop Test (response times to stimuli with congruent word and color) |
| Hyperarousal | At baseline and 8 weeks later | Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data. |
| Pads Used | Duration of Study | Pads used |
| Whether She Used Any Pads. | Duration of Study | Yes/No |
| Psychological Self-reports, Scores on Anxiety and Depression Rating Scales; | 2 weeks | State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory. |
| Quality of Life, Scores on the Women's Health Questionnaire. | 2 weeks | Self-reported vasomotor symptoms, other somatic symptoms, anxiety, depression, sleep and cognitive symptoms (memory, concentration and clumsiness problems), measured as category scores. Subjective sleep onset and total sleep times measured as 7-day averaged minutes. |
| Sleep Quality | 2 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep / Wake Pattern | Two weeks | Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake. |
Countries
United States
Participant flow
Recruitment details
Women 45 to 65 years old were mailed post-cards with the study telephone number and e-mail address. Subjects were assessed for eligibility. The PI determined eligibility based on the study criteria. Eligible subjects were informed about the study requirements, risks and benefits, and then required to read and sign a consent form.
Pre-assignment details
Placebo responders were excluded after one week.
Participants by arm
| Arm | Count |
|---|---|
| Tolterodine Tolterodine 4 mg q.d. X 8 weeks | 10 |
| Placebo A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine | 9 |
| Total | 19 |
Baseline characteristics
| Characteristic | Placebo | Tolterodine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 5.2 | 52 years STANDARD_DEVIATION 5.2 | 52 years STANDARD_DEVIATION 5.2 |
| Region of Enrollment United States | 9 participants | 10 participants | 19 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 10 | 1 / 9 |
Outcome results
Primary
Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart;
Subjects note: 1. Number of nocturnal and diurnal voids; 2) level of urgency for 7 days, graded 1 to 4, beginning after the first void on the Friday morning of week 7 and week 13 of their participation; 3) Number of incontinence episodes; 4) Relationship of incontinence to urge or stress (4 grade scale); 4) Whether she used any pads.
Time frame: 2 months
Population: No data collected or analyzed for the outcome measures.
Primary
Number of Incontinence Episodes;
Number
Time frame: Duration of Study
Population: No data collected or analyzed for the outcome measures.
Primary
Relationship of Incontinence to Urge or Stress
4-grade scale
Time frame: Duration of study
Population: No data collected or analyzed for the outcome measures.
Primary
Urgency
Level of urgency for 7 days, graded 1 to 4,
Time frame: Beginning after the first void on the Friday morning of week 7 and week 13 of their participation;
Population: No data collected or analyzed for the outcome measures.
Secondary
Cognitive Function
Motor speed (number of finger taps in 30 seconds); Continuous Performance (mean response time elicited by appearance of target alphabet letter presented in a series of letters on a monitor screen for 1 minute); Color-Word Stroop Test (response times to stimuli with congruent word and color)
Time frame: Two 20-minute sessions during 2 months
Population: No data collected or analyzed for the outcome measures.
Secondary
Hyperarousal
Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.
Time frame: At baseline and 8 weeks later
Population: No data collected or analyzed for the outcome measures.
Secondary
Pads Used
Pads used
Time frame: Duration of Study
Population: No data collected or analyzed for the outcome measures.
Secondary
Psychological Self-reports, Scores on Anxiety and Depression Rating Scales;
State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory.
Time frame: 2 weeks
Population: No data collected or analyzed for the outcome measures.
Secondary
Quality of Life, Scores on the Women's Health Questionnaire.
Self-reported vasomotor symptoms, other somatic symptoms, anxiety, depression, sleep and cognitive symptoms (memory, concentration and clumsiness problems), measured as category scores. Subjective sleep onset and total sleep times measured as 7-day averaged minutes.
Time frame: 2 weeks
Population: No data collected or analyzed for the outcome measures.
Secondary
Sleep Quality
Time frame: 2 months
Population: No data collected or analyzed for the outcome measures.
Secondary
Whether She Used Any Pads.
Yes/No
Time frame: Duration of Study
Population: No data collected or analyzed for the outcome measures.
Other Pre-specified
Sleep / Wake Pattern
Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.
Time frame: Two weeks
Population: No data collected or analyzed for the outcome measures.