Effects of Conservative Management on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleep health promotion, Urologic health promotion, Pelvic floor muscle training.
- Who it may be relevant to
- Registry conditions: Conservative Management, Diabetes Mellitus, Health-related Quality of Life, Lower Urinary Tract Symptoms. Basic parameters: 20 years — 79 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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).
Primary outcome measures
- Lower urinary tract symptoms [Time frame: Baseline]
- Lower urinary tract symptoms [Time frame: The 2-month follow-up.]
- Lower urinary tract symptoms [Time frame: The 4-month follow-up.]
- Lower urinary tract symptoms [Time frame: The 6-month follow-up.]
- Sleep Quality [Time frame: Baseline.]
- Sleep Quality [Time frame: The 2-month follow-up.]
- Sleep Quality [Time frame: The 4-month follow-up.]
- Sleep Quality [Time frame: The 6-month follow-up.]
- Total nighttime sleep [Time frame: Baseline.]
- Total nighttime sleep [Time frame: The 2-month follow-up.]
Secondary outcome measures (8)
- Health-related quality of life [Time frame: Baseline.]
- Health-related quality of life [Time frame: The 2-month follow-up.]
- Health-related quality of life [Time frame: The 4-month follow-up.]
- Health-related quality of life [Time frame: The 6-month follow-up.]
- Self-management of urologic health [Time frame: Baseline.]
- Self-management of urologic health [Time frame: The 2-month follow-up.]
- Self-management of urologic health [Time frame: The 4-month follow-up.]
- Self-management of urologic health [Time frame: The 6-month follow-up.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Cardinal Tien Hospital — New Taipei City
Identifiers
NCT: NCT05869734 · 11131006