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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

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

Study 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.

Eligibility

Primary outcome measure(s)

• Lower urinary tract symptoms — Baseline
  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.
• Lower urinary tract symptoms — The 2-month follow-up.
  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.
• Lower urinary tract symptoms — The 4-month follow-up.
  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.
• Lower urinary tract symptoms — The 6-month follow-up.
  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.
• Sleep Quality — Baseline.
  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.
• Sleep Quality — The 2-month follow-up.
  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.
• Sleep Quality — The 4-month follow-up.
  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.
• Sleep Quality — The 6-month follow-up.
  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.
• Total nighttime sleep — Baseline.
  Total nighttime sleep will be measured by a wristwatch-like actigraphy. A longer total nighttime sleep duration indicates an individual having better sleep.
• Total nighttime sleep — The 2-month follow-up.
  Total nighttime sleep will be measured by a wristwatch-like actigraphy. A longer total nighttime sleep duration indicates an individual having better sleep.
• Total nighttime sleep — The 4-month follow-up.
  Total nighttime sleep will be measured by a wristwatch-like actigraphy. A longer total nighttime sleep duration indicates an individual having better sleep.
• Total nighttime sleep — The 6-month follow-up.
  Total nighttime sleep will be measured by a wristwatch-like actigraphy. A longer total nighttime sleep duration indicates an individual having better sleep.
• Sleep onset latency — Baseline.
  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.
• Sleep onset latency — The 2-month follow-up.
  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.
• Sleep onset latency — The 4-month follow-up.
  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.
• Sleep onset latency — The 6-month follow-up.
  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.
• Wake after sleep onset — Baseline.
  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.
• Wake after sleep onset — The 2-month follow-up.
  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.
• Wake after sleep onset — The 4-month follow-up.
  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.
• Wake after sleep onset — The 6-month follow-up.
  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.
• Sleep efficiency — Baseline.
  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.
• Sleep efficiency — The 2-month follow-up.
  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.
• Sleep efficiency — The 4-month follow-up.
  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.
• Sleep efficiency — The 6-month follow-up.
  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.

Trial sites (1)

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