A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Parallel, Double-blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women.|
- Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart; [ Time Frame: 2 months ] [ Designated as safety issue: No ]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 [ Time Frame: Beginning after the first void on the Friday morning of week 7 and week 13 of their participation; ] [ Designated as safety issue: No ]Level of urgency for 7 days, graded 1 to 4,
- Number of Incontinence Episodes; [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]Number
- Relationship of Incontinence to Urge or Stress [ Time Frame: Duration of study ] [ Designated as safety issue: No ]4-grade scale
- Psychological Self-reports, Scores on Anxiety and Depression Rating Scales; [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]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. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Cognitive Function [ Time Frame: Two 20-minute sessions during 2 months ] [ Designated as safety issue: No ]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 [ Time Frame: At baseline and 8 weeks later ] [ Designated as safety issue: No ]Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.
- Whether She Used Any Pads. [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]Yes/No
- Pads Used [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]Pads used
- Sleep / Wake Pattern [ Time Frame: Two weeks ] [ Designated as safety issue: No ]Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.
|Study Start Date:||April 2006|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Tolterodine 4 mg q.d. X 8 weeks
tablet, 4 mg, daily, 1 month
Other Name: Detrol
Placebo Comparator: Placebo
A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323635
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02120|
|Principal Investigator:||Quentin R Regestein, M.D.||Brigham and Women's Hospital|