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NCT05604222 · ClinicalTrials.gov registry record · Phase 4
Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women
A Phase 4 study of Nocturia and Urgency Urinary Incontinence, sponsored by Shachi Tyagi.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05604222: Recruiting Phase 4 study of Nocturia and Urgency Urinary Incontinence, sponsored by Shachi Tyagi.
NCT05604222 is a Phase 4 study of Nocturia and Urgency Urinary Incontinence that is actively recruiting participants, run by Shachi Tyagi. The registered enrollment target is 120 participants, below the 303-participant average among 9 other Nocturia trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05604222, a Phase 4 study of Nocturia and Urgency Urinary Incontinence, is actively recruiting participants, sponsored by Shachi Tyagi.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Urgency urinary incontinence (UUI) is common in older people and vastly reduces quality of life, yet the cause and mechanism of disease are not well understood. This study will investigate the role of adding behavioral sleep intervention to the standard pharmacotherapy in treatment of UUI among older adults, and the brain mechanisms involved in continence by evaluating brain changes. This will expand the current knowledge of how the sleep affects bladder control, and better characterize the brain mechanisms in maintaining continence.
Primary Outcome
The number of incontinence episodes
Conditions Studied
Interventions
- DRUG Mirabegron 50 MG
- BEHAVIORAL Brief Behavioral Treatment for Insomnia
Study Locations (1)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-03-05 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 4 |
What NCT05604222 shows while recruiting
NCT05604222 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 303-participant average among 9 other Nocturia trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Nocturia appearing as the primary indexed condition, and to 2 interventions - of which Mirabegron 50 MG is the first listed.
NCT05604222 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05604222 about?
NCT05604222 is a clinical study titled "Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women". Urgency urinary incontinence (UUI) is common in older people and vastly reduces quality of life, yet the cause and mechanism of disease are not well understood. This study will investigate the role of adding behavioral sleep intervention to the standard pharmacotherapy in treatment of UUI among olde...
What is the current status of trial NCT05604222?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2023-03-05. Estimated completion is 2027-03-31.
What conditions does trial NCT05604222 study?
This clinical trial studies the following conditions: Nocturia, Urgency Urinary Incontinence.
What interventions are being tested in trial NCT05604222?
The interventions under investigation include: Mirabegron 50 MG (DRUG), Brief Behavioral Treatment for Insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT05604222?
This trial is sponsored by Shachi Tyagi, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05604222 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05604222's enrollment target sits among peer trials
120 6th of 9 higher than 4 of 9 other Nocturia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nocturia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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