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NCT04922255 · ClinicalTrials.gov registry record · NA
Cystic Fibrosis and Urinary Incontinence
A NA study, sponsored by Megan Bradley.
- Terminated
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT04922255 is a NA study that was terminated before completion, run by Megan Bradley. The registered enrollment target is 15 participants.
The verdict
NCT04922255, a NA study, was terminated before completion, sponsored by Megan Bradley.
- TERMINATED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
Evaluate the feasibility of a randomized controlled trial of non-surgical urinary incontinence (UI) management options for women with CF. The investigators will complete a pilot, feasibility study (n=30) to compare tolerability and symptom relief in women with CF and UI. Subjects will be recruited from the University of Pittsburgh Cystic Fibrosis Center after demonstrating bother from UI on initial phone script. Participants will undergo UI questionnaires and undergo a pelvic examination, non-invasive bladder scan ultrasound and a provocative stress test and then be randomized to either a disposable urethral support device (Impressa®), an absorbent product (Speax Reusable Underwear), or Pelvic floor muscle therapy. The primary outcome will be to determine the feasibility and tolerability of these options. Hypothesis: All three non-surgical UI management options for women are feasible (as measured by 80% adherence to treatment assignment over 7 days) and tolerable (as measured by patient report via questionnaire). The results from the proposed aims will provide important information about the experiences and symptom burden of women with CF and UI. Importantly, the investigators will also be able to answer the important questions of "Can it work?" and "Does it work?" as the investigators seek to construct the definitive, adequately powered trial of these therapies in women with CF and UI.
Interventions
- BEHAVIORAL Pelvic floor physical therapy
- DEVICE Reusable Underwear
- DEVICE Disposable urethral support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2023-10-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04922255
The ClinicalTrials.gov registry entry for NCT04922255 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Megan Bradley, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pelvic floor physical therapy is the first listed.
NCT04922255 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04922255 about?
NCT04922255 is a clinical study titled "Cystic Fibrosis and Urinary Incontinence". Evaluate the feasibility of a randomized controlled trial of non-surgical urinary incontinence (UI) management options for women with CF. The investigators will complete a pilot, feasibility study (n=30) to compare tolerability and symptom relief in women with CF and UI. Subjects will be recruited f...
What is the current status of trial NCT04922255?
This trial is currently terminated. It is a NA study. The enrollment target is 15 participants. The study started on 2021-09-01. Estimated completion is 2023-10-01.
What interventions are being tested in trial NCT04922255?
The interventions under investigation include: Pelvic floor physical therapy (BEHAVIORAL), Reusable Underwear (DEVICE), Disposable urethral support (DEVICE).
Who is sponsoring clinical trial NCT04922255?
This trial is sponsored by Megan Bradley, which has 3 total clinical trials registered on ClinicalTrials.gov.
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