Cystic Fibrosis and Urinary Incontinence
Stopped early · Not applicable
Conditions studied: Urinary Incontinence, Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT04922255
- Run by
- Megan Bradley
- People needed
- 15
- Starts
- 2021-09-01
- Expected to finish
- 2023-10-01
- Last updated by the study team
- 2024-10-01
Who can join
Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female age 18 years or older
- Diagnosis of CF
- Self-reported UI (at least answer of "a little" on King's Health Questionnaire - Question #2)
- Fluent in spoken English
- Ability to present for in-office exam and study procedures
You may not qualify if…
- Age <18 years
- No UI
- Inability to comply with study protocol
- No diagnosis of Cystic Fibrosis
- Pregnant
Where it is running
- Magee Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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