Cystic Fibrosis and Urinary Incontinence

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.

Conditions

• Urinary Incontinence
• Cystic Fibrosis

Interventions

DEVICE

Reusable Underwear

Reusable Underwear are similarly available for purchase online and are absorbent underwear for bladder leak protection

DEVICE

Disposable urethral support

The disposable urethral support is a tampon-like device that is available over the counter to help women with urinary incontinence (UI)

BEHAVIORAL

Pelvic floor physical therapy

Experienced pelvic health physical therapists (at University of Pittsburgh) will complete two visits one week apart.

Sponsors & Collaborators

• Cystic Fibrosis Foundation

  collaborator OTHER

• Megan Bradley

  lead OTHER

Principal Investigators

• Megan Bradley, MD · University of Pittsbugh School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2023-10-01

Completion

2023-10-01

FDA Device

Yes

Countries

• United States

Study Locations