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

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

Women with type 2 diabetes (n=90) 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lower Urinary Tract Symptoms; Diabetes Mellitus; Sleep; Self-management; Sleep Health; Health-related Quality of Life; Conservative Management
• Intervention / Treatment: Behavioral: Sleep health promotion; Behavioral: Urologic health promotion; Behavioral: Pelvic floor muscle training

Detailed Description

Women with type 2 diabetes (n=90) 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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 231
    • Cardinal Tien Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group A; The intervention group A receives conservative management with sleep hygiene related adjustments, pelvic floor muscle training, and urologic health promotion.	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.; Behavioral: Urologic health promotion; We will provide information related to urologic health promotion in three groups (2 experimental groups and 1 comparison group).; Behavioral: Pelvic floor muscle training; We will provide information related to pelvic floor muscle training in three groups (2 experimental groups and 1 comparison group).
Experimental: Intervention group B; The intervention group B receives conservative management with brief behavioral treatment for insomnia (BBTI), pelvic floor muscle training, and urologic health promotion.	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.; Behavioral: Urologic health promotion; We will provide information related to urologic health promotion in three groups (2 experimental groups and 1 comparison group).; Behavioral: Pelvic floor muscle training; We will provide information related to pelvic floor muscle training in three groups (2 experimental groups and 1 comparison group).
Sham Comparator: Comparison group; The comparison group receives information related to pelvic floor muscle training and urologic health promotion.	Behavioral: Urologic health promotion; We will provide information related to urologic health promotion in three groups (2 experimental groups and 1 comparison group).; Behavioral: Pelvic floor muscle training; We will provide information related to pelvic floor muscle training in three groups (2 experimental groups and 1 comparison group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University
• Collaborators: Cardinal Tien Hospital
• Investigators: Principal Investigator: Yuan-Mei Liao, PhD, National Yang Ming Chiao Tung University

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Urological Manifestations; Glucose Metabolism Disorders; Diabetes Mellitus; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 11131006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No