Last reviewed · How we verify

NCT05869734

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

ENROLLING BY INVITATION NA Last updated 21 November 2024
What this trial tests

NA trial testing Sleep health promotion in Conservative Management in 90 participants. Enrolling by invitation.

Timeline
26 April 2023
Primary endpoint
31 August 2025
31 December 2025

Quick facts

Lead sponsorNational Yang Ming Chiao Tung University
PhaseNA
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment90
Start date26 April 2023
Primary completion31 August 2025
Estimated completion31 December 2025
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

National Yang Ming Chiao Tung University

Who can join

Adults 20 to 79, female only, with Conservative Management or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Sleep health promotion

Trials testing the same drug.

Other recruiting trials for Conservative Management

Currently open trials in the same condition.

Other National Yang Ming Chiao Tung University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05869734.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing