Effects of Conservative Management on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2023
CompletedStudy Start
First participant enrolled
April 26, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 21, 2024
November 1, 2024
2.4 years
April 26, 2023
November 19, 2024
Conditions
Outcome Measures
Primary Outcomes (24)
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 Outcomes (8)
Health-related quality of life
Baseline.
Health-related quality of life
The 2-month follow-up.
Health-related quality of life
The 4-month follow-up.
Health-related quality of life
The 6-month follow-up.
Self-management of urologic health
Baseline.
- +3 more secondary outcomes
Study Arms (3)
Intervention group A
EXPERIMENTALThe intervention group A receives conservative management with sleep hygiene related adjustments, pelvic floor muscle training, and urologic health promotion.
Intervention group B
EXPERIMENTALThe intervention group B receives conservative management with brief behavioral treatment for insomnia (BBTI), pelvic floor muscle training, and urologic health promotion.
Comparison group
SHAM COMPARATORThe comparison group receives information related to pelvic floor muscle training and urologic health promotion.
Interventions
We will provide sleep hygiene related adjustments in the intervention group A; and brief behavioral treatment for insomnia (BBTI) in the intervention group B.
We will provide information related to urologic health promotion in three groups (2 experimental groups and 1 comparison group).
We will provide information related to pelvic floor muscle training in three groups (2 experimental groups and 1 comparison group).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Yang Ming Chiao Tung Universitylead
- Cardinal Tien Hospitalcollaborator
Study Sites (1)
Cardinal Tien Hospital
New Taipei City, 231, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuan-Mei Liao, PhD
National Yang Ming Chiao Tung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 26, 2023
First Posted
May 22, 2023
Study Start
April 26, 2023
Primary Completion
August 31, 2025
Study Completion
December 31, 2025
Last Updated
November 21, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share