Cystic Fibrosis and Urinary Incontinence
Condition: Urinary Incontinence; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Urinary Incontinence; Enuresis; Fibrosis
Study type: Interventional

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.
    

Detailed description: 
      Study Procedures: Participants will be recruited at routine cystic fibrosis (CF) clinic
      visits and via telephone screening. The investigators will again utilize the ISI for
      screening procedures with subjects required to have at incontinence at least as frequent as
      'less than once a month' and at least as 'drops' to be eligible for enrollment. Informed
      consent will be obtained before any study procedures are initiated. Initial demographic
      questions and the King's Health Questionnaire (KHQ) will be completed at the baseline visit.
      Subjects will be given materials to complete a 2-day bladder diary. The bladder diary has
      participants track what they take in (fluids) and also their voided volumes throughout the
      day and night. Subjects will be given a hat to void in a collect the numbers/volume of voids
      and also leakage episodes. Pregnancy will be excluded by self-report. Participants will then
      have a pelvic exam for a visual urethral mobility examination and assessment of pelvic floor
      muscle strength to be completed by the principal investigator. The principal investigator
      will additionally first perform a bladder scan ultrasound to assess current bladder volume
      and then a cough stress test (CST). The exam will be performed in the supine/lithotomy
      position with ≥300 mL of fluid in the bladder. The investigators will have the subject cough
      forcefully 1-4 times and the examiner will directly visualize the urethral meatus for the
      presence of leakage. Leakage of fluid from the urethral meatus coincident with/simultaneous
      to the cough(s) is considered a positive test consistent with stress urinary incontinence
      (SUI).

      Randomized feasibility trial (Table 2). At the baseline visit, women will be given a brief
      description of the three different treatment options and be initially asked to rank initial
      choice for treatment. Participants will then be randomized to either a disposable urethral
      support device (Impressa®), Speax™ Reusable Underwear, or pelvic floor muscle therapy (PFMT).
      Randomization will be in a 1:1:1 allocation without stratification by incontinence severity.
      The disposable Impressa® urethral support is a tampon-like device that is available over the
      counter to help women with urinary incontinence (UI). Speax Reusable Underwear are similarly
      available for purchase online and are absorbent underwear for bladder leak protection. Both
      the Impressa and Speax are commercially available and the Impressa is FDA approved. The Speax
      underwear are not a FDA regulated product. Urethral support device cohort - A week supply of
      the Impressa device will be provided and participants will be asked to complete a daily
      bladder diary for a total of 7 days. The instructions for use booklet will be provided.
      Subjects will be told that they can continuously utilize one Impressa for up to 12 hours. The
      investigators will ask subjects to wear for at least 12 hours a day but up to 24 if they
      desire. Reusable absorbent pad cohort - Three pairs of Speax underwear will be provided and
      subjects will complete a similar daily UI diary for 7 days. Subjects will be instructed to
      wear one pair of speax daily and may wash as they desire. Subjects will be provided the
      website for the product and The investigators will allow them to order whatever pair/size the
      subject desires. https://www.shethinx.com/pages/speax. PFMT cohort - Experienced pelvic
      health physical therapists (at both University of Pittsburgh) will complete two visits one
      week apart. Each PFMT visit will take ~60 minutes. The investigators will develop a
      standardized pelvic floor exercise intervention based on previous RCT for PFMT in women with
      MUI. The intervention will comprise: 1) Bladder training and delayed voiding techniques 2)
      Urgency suppression 3) SUI strategies (e.g., 'knack') and 4) Pelvic floor muscle (PFM)
      training for those agreeable to internal exams. The investigators will utilize Diaphragmatic
      breathing, Happy Baby Stretch with pelvic floor muscle (PFM) relaxation and lower abdominal
      myofascial release (MFR) to start. These are all non-internal stretching type exercises
      similar to yoga and will be performed for ~20-30 minutes. If the subject is willing the
      investigators will consider internal pelvic floor muscle training which will involve the
      physical therapist inserting one digit into the vagina in order to aid in muscle
      coordination. This will also be done for 20-30 minutes.

      Subjects will not be blinded to their group assignment given the nature of the differences in
      management options. At the end of the treatment assignment all subjects will repeat the KHQ
      and a patient global impression of improvement (PGI-I). The 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). All subjects
      will complete the follow-up questionnaires 7-days after the beginning of their assigned
      therapy.

      Given the opportunity to gather acceptability on these options for a sensitive issue,
      subjects will be offered an option to further participate in one alternate therapy of their
      choosing. If subjects select this option, investigators will organize an additional week of
      therapy. Participants will only have to complete a BSW questionnaire and another PGI-I at the
      end of therapy. This is an option for all women in the study even if they initially had been
      randomized to their preferred option as participants may ultimately have not really liked
      that choice.

      Acceptability and Feasibility assessment: Urethral support device cohort and Reusable
      absorbent pad cohort: Feasibility will be evaluated through assessment of use and product
      performance. Logs regarding utilization of assigned product will be completed daily. Patient
      treatment preference will be assessed after completion of both therapies utilizing the
      product performance questionnaire (PPQ). The PPQ is a 13-item product questionnaire that
      consists of product questions that are specific to incontinence products and includes
      questions about overall impression of product, ability to hold urine, ability to prevent
      odor, fit, discreteness, comfort when wet and dry, and ability to keep skin dry. PFMT cohort:
      Feasibility will be evaluated through assessment of adherence and self-reported success with
      ability to perform exercises. Adherence to intervention sessions will be documented by
      physical therapist using attendance logs. Adherence to home practice will be documented by
      participants in home logs that included the dates and times of practice. At the end of each
      physical therapy visit, participants will be asked to rate their confidence in performing the
      PFMT exercises featured in their program (extremely, very, moderately, somewhat, and not at
      all confident).

      At the end of the study, all participants will be asked to indicate how easy it would be to
      continue practicing their assignment intervention (extremely, very, moderately, somewhat, and
      not at all easy). All subjects will complete a Benefit, Satisfaction, and Willingness to
      Continue (BSW) questionnaire. The investigators will consider therapy feasible (as measured
      by 80% adherence to treatment assignment over 7 days) and tolerable (as measured by patient
      report via questionnaire). By allowing subjects to choose another one of the arms after their
      randomization this will give us further, important information about feasibility and patient
      preference for a larger trial.
    

Intervention name(s): Reusable Underwear; Disposable urethral support; Pelvic floor physical therapy
Intervention type(s): Device; Device; Behavioral
Intervention description(s): Reusable Underwear are similarly available for purchase online and are absorbent underwear for bladder leak protection; The disposable urethral support is a tampon-like device that is available over the counter to help women with urinary incontinence (UI); Experienced pelvic health physical therapists (at University of Pittsburgh) will complete two visits one week apart.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment