Cystic Fibrosis and Urinary Incontinence

NCT04922255 | Terminated Results FDA Device

• 1 other identifier: STUDY21010012
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Improvement-Incontinence

  The Patient Global Impression of Improvement-Incontinence (PGI-I) is a validated one question measure rating their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse). It is a score calculated at Day 7.

  7 days

Secondary Outcomes (4)

• Patient Treatment Preference

  7 days

• King's Health Questionnaire

  7 days

• Adherence Logs

  7 days

• Benefits, Satisfaction, and Willingness to Continue

  7 days

Study Arms (3)

disposable urethral support device

ACTIVE COMPARATOR

disposable urethral support device

Device: Disposable urethral support

Reusable Underwear

ACTIVE COMPARATOR

Reusable Underwear

Device: Reusable Underwear

pelvic floor muscle therapy (PFMT)

ACTIVE COMPARATOR

Pelvic floor muscle therapy

Behavioral: Pelvic floor physical therapy

Interventions

Reusable Underwear DEVICE

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

Reusable Underwear

Disposable urethral support DEVICE

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

disposable urethral support device

Pelvic floor physical therapy BEHAVIORAL

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

pelvic floor muscle therapy (PFMT)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Megan Bradley: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Megan Bradley, MD
• Organization: University of Pittsburgh

megsbrad2010@gmail.com

2487701681

Study Officials

• Megan Bradley, MD

  University of Pittsbugh School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: June 10, 2021
• Study Start: September 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)