Effects of Conservative Management on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Effects of Conservative Management Incorporating Urologic Health Promotion and Sleep Health Promotion on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869734
• Other study ID #: 11131006
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Health-related Quality of Life
• Lower Urinary Tract Symptoms
• Self-management
• Sleep
• Sleep Health

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.