Clinical trial NCT05869734: Effects of Conservative Management on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Conservative Management
Diabetes Mellitus
Health-related Quality of Life
Lower Urinary Tract Symptoms
Self-management
Sleep
Sleep Health
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Cardinal Tien Hospital
First posted: 2023-05-22
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lower urinary tract symptoms
timeFrame: Baseline
measure: Lower urinary tract symptoms
timeFrame: The 2-month follow-up.
measure: Lower urinary tract symptoms
timeFrame: The 4-month follow-up.
measure: Lower urinary tract symptoms
timeFrame: The 6-month follow-up.
measure: Sleep Quality
timeFrame: Baseline.
measure: Sleep Quality
timeFrame: The 2-month follow-up.
measure: Sleep Quality
timeFrame: The 4-month follow-up.
measure: Sleep Quality
timeFrame: The 6-month follow-up.
measure: Total nighttime sleep
timeFrame: Baseline.
measure: Total nighttime sleep
timeFrame: The 2-month follow-up.
measure: Total nighttime sleep
timeFrame: The 4-month follow-up.
measure: Total nighttime sleep
timeFrame: The 6-month follow-up.
measure: Sleep onset latency
timeFrame: Baseline.
measure: Sleep onset latency
timeFrame: The 2-month follow-up.
measure: Sleep onset latency
timeFrame: The 4-month follow-up.
measure: Sleep onset latency
timeFrame: The 6-month follow-up.
measure: Wake after sleep onset
timeFrame: Baseline.
measure: Wake after sleep onset
timeFrame: The 2-month follow-up.
measure: Wake after sleep onset
timeFrame: The 4-month follow-up.
measure: Wake after sleep onset
timeFrame: The 6-month follow-up.
measure: Sleep efficiency
timeFrame: Baseline.
measure: Sleep efficiency
timeFrame: The 2-month follow-up.
measure: Sleep efficiency
timeFrame: The 4-month follow-up.
measure: Sleep efficiency
timeFrame: The 6-month follow-up.
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Baseline.
measure: Health-related quality of life
timeFrame: The 2-month follow-up.
measure: Health-related quality of life
timeFrame: The 4-month follow-up.
measure: Health-related quality of life
timeFrame: The 6-month follow-up.
measure: Self-management of urologic health
timeFrame: Baseline.
measure: Self-management of urologic health
timeFrame: The 2-month follow-up.
measure: Self-management of urologic health
timeFrame: The 4-month follow-up.
measure: Self-management of urologic health
timeFrame: The 6-month follow-up.
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Cardinal Tien Hospital
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Yuan-Mei Liao, PhD
role: PRINCIPAL_INVESTIGATOR
References: