NCT05869734

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: National Yang Ming Chiao Tung University · Academic / Other
• Sex: Female
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-04-26
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2023-05-22
• Last updated: 2024-11-21

Locations

1 site across 1 country: Taiwan