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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group A

The intervention group A receives conservative management with sleep hygiene related adjustments, pelvic floor muscle training, and urologic health promotion.

Group Type EXPERIMENTAL

Sleep health promotion

Intervention Type BEHAVIORAL

We will provide sleep hygiene related adjustments in the intervention group A; and brief behavioral treatment for insomnia (BBTI) in the intervention group B.

Urologic health promotion

Intervention Type BEHAVIORAL

We will provide information related to urologic health promotion in three groups (2 experimental groups and 1 comparison group).

Pelvic floor muscle training

Intervention Type BEHAVIORAL

We will provide information related to pelvic floor muscle training in three groups (2 experimental groups and 1 comparison group).

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.

Group Type EXPERIMENTAL

Sleep health promotion

Intervention Type BEHAVIORAL

We will provide sleep hygiene related adjustments in the intervention group A; and brief behavioral treatment for insomnia (BBTI) in the intervention group B.

Urologic health promotion

Intervention Type BEHAVIORAL

We will provide information related to urologic health promotion in three groups (2 experimental groups and 1 comparison group).

Pelvic floor muscle training

Intervention Type BEHAVIORAL

We will provide information related to pelvic floor muscle training in three groups (2 experimental groups and 1 comparison group).

Comparison group

The comparison group receives information related to pelvic floor muscle training and urologic health promotion.

Group Type SHAM_COMPARATOR

Urologic health promotion

Intervention Type BEHAVIORAL

We will provide information related to urologic health promotion in three groups (2 experimental groups and 1 comparison group).

Pelvic floor muscle training

Intervention Type BEHAVIORAL

We will provide information related to pelvic floor muscle training in three groups (2 experimental groups and 1 comparison group).

Interventions

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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.

Intervention Type BEHAVIORAL

Urologic health promotion

We will provide information related to urologic health promotion in three groups (2 experimental groups and 1 comparison group).

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No