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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05869734
Other study ID # 11131006
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 30, 2023
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source National Yang Ming University
Contact Yuan-Mei Liao, PhD
Phone 0952958182
Email ymliao@nycu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Women with type 2 diabetes (n=150) experiencing ≥1 storage lower urinary tract symptoms and poor sleep health will be recruited from the outpatient departments or wards/units of the selected hospitals/clinics. Our study aims to examine the effects of conservative management incorporating urologic health promotion and sleep health promotion on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life. Women who agree to participate will be randomly assigned into the intervention group A, intervention group B, or comparison group. The intervention group A receives a 4-month conservative management with sleep hygiene related adjustments, pelvic floor muscle training, and urologic health promotion. The intervention group B receives a 4-month conservative management with brief behavioral treatment for insomnia (BBTI), pelvic floor muscle training, and urologic health promotion. The comparison group receives information related to pelvic floor muscle training and urologic health promotion, and receives a brief conservative management related to sleep hygiene adjustments after the completion of data collection. Information related to intervention effects is obtained by a questionnaire, a wristwatch-like actigraphy, and physical activity/diet/voiding/sleep logs from all participants at 4 data collection points: baseline, and 2-, 4-, 6-month follow-ups. Our study hypothesis is that the intervention effects on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life in the intervention group A or B are superior to the changes revealed in the comparison group.


Description:

Women with type 2 diabetes (n=150) experiencing ≥1 storage lower urinary tract symptoms and poor sleep health will be recruited from the outpatient departments or wards/units of the selected hospitals/clinics. Our study aims to examine the effects of conservative management incorporating urologic health promotion and sleep health promotion on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life. Women who agree to participate will be randomly assigned into the intervention group A, intervention group B, or comparison group. The intervention group A receives a 4-month conservative management with sleep hygiene related adjustments, pelvic floor muscle training, and urologic health promotion. The intervention group B receives a 4-month conservative management with brief behavioral treatment for insomnia (BBTI), pelvic floor muscle training, and urologic health promotion. The comparison group receives information related to pelvic floor muscle training and urologic health promotion, and receives a brief conservative management related to sleep hygiene adjustments after the completion of data collection. Information related to intervention effects is obtained by a questionnaire, a wristwatch-like actigraphy, and physical activity/diet/voiding/sleep logs from all participants at 4 data collection points: baseline, and 2-, 4-, 6-month follow-ups. Our study hypothesis is that the intervention effects on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life in the intervention group A or B are superior to the changes revealed in the comparison group. The effects of the provided intervention on storage lower urinary tract symptoms, sleep quality, urologic health self-management behaviors, and health-related quality of life will be examined by Generalized Estimating Equations procedures with the estimations of effect sizes. Results of Chi-squared tests and descriptive statistics will also be used to present the intervention effects.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria: - Women - Age 50-79 years - Clinical diagnosis of diabetes >3 months - Experiencing =1 storage lower urinary tract symptoms in the past 1 month - Experiencing poor sleep health in the past 1 month - Intact cognition and communication abilities Exclusion Criteria: - Receiving urologic problems related treatments in the past 3 months - Receiving sleep problems related treatments in the past 3 months - Receiving mental problems related treatments in the past 3 months - Having a history of spinal surgery, cardiovascular, renal, or nervous system diseases - Having severe mental illness - Having physical impairments

Study Design


Intervention

Behavioral:
Sleep health promotion
We will provide sleep hygiene related adjustments in the intervention group A; and brief behavioral treatment for insomnia (BBTI) in the intervention group B.
Urologic health promotion
We will provide information related to urologic health promotion in three groups (2 experimental groups and 1 comparison group).
Pelvic floor muscle training
We will provide information related to pelvic floor muscle training in three groups (2 experimental groups and 1 comparison group).

Locations

Country Name City State
Taiwan Cardinal Tien Hospital New Taipei City

Sponsors (2)

Lead Sponsor Collaborator
National Yang Ming University Cardinal Tien Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lower urinary tract symptoms We will use a lower urinary tract symptoms scale to assess eight common female lower urinary tract symptoms: nocturia, urinary incontinence, increased daytime urinary frequency, urgency, a slow stream, an intermittent stream, hesitancy, and a feeling of incomplete emptying. The total lower urinary tract symptoms score ranges from 0 to 8; a higher total score indicates an individual experiencing more types of lower urinary tract symptoms. Baseline
Primary Lower urinary tract symptoms We will use a lower urinary tract symptoms scale to assess eight common female lower urinary tract symptoms: nocturia, urinary incontinence, increased daytime urinary frequency, urgency, a slow stream, an intermittent stream, hesitancy, and a feeling of incomplete emptying. The total lower urinary tract symptoms score ranges from 0 to 8; a higher total score indicates an individual experiencing more types of lower urinary tract symptoms. The 2-month follow-up.
Primary Lower urinary tract symptoms We will use a lower urinary tract symptoms scale to assess eight common female lower urinary tract symptoms: nocturia, urinary incontinence, increased daytime urinary frequency, urgency, a slow stream, an intermittent stream, hesitancy, and a feeling of incomplete emptying. The total lower urinary tract symptoms score ranges from 0 to 8; a higher total score indicates an individual experiencing more types of lower urinary tract symptoms. The 4-month follow-up.
Primary Lower urinary tract symptoms We will use a lower urinary tract symptoms scale to assess eight common female lower urinary tract symptoms: nocturia, urinary incontinence, increased daytime urinary frequency, urgency, a slow stream, an intermittent stream, hesitancy, and a feeling of incomplete emptying. The total lower urinary tract symptoms score ranges from 0 to 8; a higher total score indicates an individual experiencing more types of lower urinary tract symptoms. The 6-month follow-up.
Primary Sleep Quality Sleep quality will be measured by the Chinese version of the Pittsburgh Sleep Quality Index. The Chinese version of the Pittsburgh Sleep Quality Index score ranges from 0 to 21; a lower Chinese version of the Pittsburgh Sleep Quality Index score indicates an individual experiencing better subjective sleep quality. Baseline.
Primary Sleep Quality Sleep quality will be measured by the Chinese version of the Pittsburgh Sleep Quality Index. The Chinese version of the Pittsburgh Sleep Quality Index score ranges from 0 to 21; a lower Chinese version of the Pittsburgh Sleep Quality Index score indicates an individual experiencing better subjective sleep quality. The 2-month follow-up.
Primary Sleep Quality Sleep quality will be measured by the Chinese version of the Pittsburgh Sleep Quality Index. The Chinese version of the Pittsburgh Sleep Quality Index score ranges from 0 to 21; a lower Chinese version of the Pittsburgh Sleep Quality Index score indicates an individual experiencing better subjective sleep quality. The 4-month follow-up.
Primary Sleep Quality Sleep quality will be measured by the Chinese version of the Pittsburgh Sleep Quality Index. The Chinese version of the Pittsburgh Sleep Quality Index score ranges from 0 to 21; a lower Chinese version of the Pittsburgh Sleep Quality Index score indicates an individual experiencing better subjective sleep quality. The 6-month follow-up.
Primary Total nighttime sleep Total nighttime sleep will be measured by a wristwatch-like actigraphy. A longer total nighttime sleep duration indicates an individual having better sleep. Baseline.
Primary Total nighttime sleep Total nighttime sleep will be measured by a wristwatch-like actigraphy. A longer total nighttime sleep duration indicates an individual having better sleep. The 2-month follow-up.
Primary Total nighttime sleep Total nighttime sleep will be measured by a wristwatch-like actigraphy. A longer total nighttime sleep duration indicates an individual having better sleep. The 4-month follow-up.
Primary Total nighttime sleep Total nighttime sleep will be measured by a wristwatch-like actigraphy. A longer total nighttime sleep duration indicates an individual having better sleep. The 6-month follow-up.
Primary Sleep onset latency Sleep onset latency, the length of time that it takes to fall asleep, will be measured by a wristwatch-like actigraphy. A shorter sleep onset latency indicates that an individual is easier to fall asleep. Baseline.
Primary Sleep onset latency Sleep onset latency, the length of time that it takes to fall asleep, will be measured by a wristwatch-like actigraphy. A shorter sleep onset latency indicates that an individual is easier to fall asleep. The 2-month follow-up.
Primary Sleep onset latency Sleep onset latency, the length of time that it takes to fall asleep, will be measured by a wristwatch-like actigraphy. A shorter sleep onset latency indicates that an individual is easier to fall asleep. The 4-month follow-up.
Primary Sleep onset latency Sleep onset latency, the length of time that it takes to fall asleep, will be measured by a wristwatch-like actigraphy. A shorter sleep onset latency indicates that an individual is easier to fall asleep. The 6-month follow-up.
Primary Wake after sleep onset Wake after sleep onset, the amount of time scored as wake between sleep onset and sleep offset, will be measured by a wristwatch-like actigraphy. A shorter wake after sleep onset indicates an individual having better sleep. Baseline.
Primary Wake after sleep onset Wake after sleep onset, the amount of time scored as wake between sleep onset and sleep offset, will be measured by a wristwatch-like actigraphy. A shorter wake after sleep onset indicates an individual having better sleep. The 2-month follow-up.
Primary Wake after sleep onset Wake after sleep onset, the amount of time scored as wake between sleep onset and sleep offset, will be measured by a wristwatch-like actigraphy. A shorter wake after sleep onset indicates an individual having better sleep. The 4-month follow-up.
Primary Wake after sleep onset Wake after sleep onset, the amount of time scored as wake between sleep onset and sleep offset, will be measured by a wristwatch-like actigraphy. A shorter wake after sleep onset indicates an individual having better sleep. The 6-month follow-up.
Primary Sleep efficiency Sleep efficiency will be measured by a wristwatch-like actigraphy. Sleep efficiency is calculated as the ratio of total nighttime sleep to total time in bed multiplied by 100. A higher sleep efficiency (0 to 100) indicates an individual having better objective sleep quality. Baseline.
Primary Sleep efficiency Sleep efficiency will be measured by a wristwatch-like actigraphy. Sleep efficiency is calculated as the ratio of total nighttime sleep to total time in bed multiplied by 100. A higher sleep efficiency (0 to 100) indicates an individual having better objective sleep quality. The 2-month follow-up.
Primary Sleep efficiency Sleep efficiency will be measured by a wristwatch-like actigraphy. Sleep efficiency is calculated as the ratio of total nighttime sleep to total time in bed multiplied by 100. A higher sleep efficiency (0 to 100) indicates an individual having better objective sleep quality. The 4-month follow-up.
Primary Sleep efficiency Sleep efficiency will be measured by a wristwatch-like actigraphy. Sleep efficiency is calculated as the ratio of total nighttime sleep to total time in bed multiplied by 100. A higher sleep efficiency (0 to 100) indicates an individual having better objective sleep quality. The 6-month follow-up.
Secondary Health-related quality of life The Short Form-36 Health Survey including a probe of self-perceived changes in health (1 item) and 35 items belonged to eight aspects will be used to measure health-related quality of life. The eight aspect scores (0 to100) will be used to calculate the physical and mental component summary scores. A higher aspect score indicates an individual having a better health-related quality of life on that aspect; a higher physical or mental component summary score indicates an individual having a superior combination of physical or mental functions. Baseline.
Secondary Health-related quality of life The Short Form-36 Health Survey including a probe of self-perceived changes in health (1 item) and 35 items belonged to eight aspects will be used to measure health-related quality of life. The eight aspect scores (0 to100) will be used to calculate the physical and mental component summary scores. A higher aspect score indicates an individual having a better health-related quality of life on that aspect; a higher physical or mental component summary score indicates an individual having a superior combination of physical or mental functions. The 2-month follow-up.
Secondary Health-related quality of life The Short Form-36 Health Survey including a probe of self-perceived changes in health (1 item) and 35 items belonged to eight aspects will be used to measure health-related quality of life. The eight aspect scores (0 to100) will be used to calculate the physical and mental component summary scores. A higher aspect score indicates an individual having a better health-related quality of life on that aspect; a higher physical or mental component summary score indicates an individual having a superior combination of physical or mental functions. The 4-month follow-up.
Secondary Health-related quality of life The Short Form-36 Health Survey including a probe of self-perceived changes in health (1 item) and 35 items belonged to eight aspects will be used to measure health-related quality of life. The eight aspect scores (0 to100) will be used to calculate the physical and mental component summary scores. A higher aspect score indicates an individual having a better health-related quality of life on that aspect; a higher physical or mental component summary score indicates an individual having a superior combination of physical or mental functions. The 6-month follow-up.
Secondary Self-management of urologic health The self-management of urologic health scale will be used to measure self-management behaviors relating to urologic health promotion. A higher scale score indicates an individual having better urologic health self-management behaviors. Baseline.
Secondary Self-management of urologic health The self-management of urologic health scale will be used to measure self-management behaviors relating to urologic health promotion. A higher scale score indicates an individual having better urologic health self-management behaviors. The 2-month follow-up.
Secondary Self-management of urologic health The self-management of urologic health scale will be used to measure self-management behaviors relating to urologic health promotion. A higher scale score indicates an individual having better urologic health self-management behaviors. The 4-month follow-up.
Secondary Self-management of urologic health The self-management of urologic health scale will be used to measure self-management behaviors relating to urologic health promotion. A higher scale score indicates an individual having better urologic health self-management behaviors. The 6-month follow-up.
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