Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323635
Status:
TERMINATED
Last Update Posted:
2018-03-29
First Post:
2006-05-05
Brief Title:
A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Parallel Double-blind Comparison of Tolterodine vs Placebo Treatments for Nocturia in Postmenopausal Women
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
New department chairman instructed PI to discontinue study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens sleep mood and performance on cognitive tests
We will also measure whether between these two treatment conditions there are any differences in womens 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 nights 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
Many factors determine how people say they sleep such as their sleep as recorded by sleep-measuring instruments how closely they notice their nights 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None