Prevalence and Treatment of Urinary Incontinence in Women With Cystic Fibrosis and Chronic Obstructive Pulmonary Disease
Condition: Cystic Fibrosis; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Cystic Fibrosis; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Urinary Incontinence; Enuresis; Fibrosis
Study type: Interventional

Summary: 
      Women with chronic lung disease characterised by chronic cough report urinary incontinence.
      Recently there have been reports of increased urinary incontinence in girls and women with
      cystic fibrosis. While coughing is a known risk factor for stress incontinence, other risk
      factors and causes are poorly understood in this population. Treatment of incontinence for
      patients with chronic lung disease is also poorly addressed, adding to the burden of disease
      for women with chronic lung disease, carers and the health system. This project will estimate
      the prevalence of women with CF and COPD compared to healthy age matched controls and will
      evaluate the effect of a specific treatment and management program for these patients. The
      results will be disseminated to respiratory health professionals. We hypothesise that women
      with chronic cough will have a higher incidence of urinary incontinence than healthy controls
      and that a specific treatment program will result in alleviation of the problems and improved
      quality of life.
    

Detailed description: 
      This project will be undertaken in two phases:

      Phase 1 will involve a mailed out screening questionnaire survey of a sample of 50-60 women
      with CF and 50-60 women with COPD to investigate the prevalence of incontinence in these
      populations. For subjects requiring assistance an independent physiotherapist is available to
      assist them with completion of the questionnaire over the telephone. Return stamped addressed
      envelopes will be provided to each subject in the initial mail-out. The following types of
      incontinence will be investigated: stress incontinence, urge incontinence, faecal
      incontinence, faecal urgency, nocturnal enuresis, voiding dysfunction, insensible urine loss,
      defaecation difficulty, known prolapse, childhood enuresis.

      Phase 2 will be an assessment and interventional study. Subjects will be measured before and
      after the treatment intervention and followed up for three months using the following
      validated outcome measures:

        -  Symptoms measures: 3-day frequency-volume chart, 24-hour pad weigh test, 7-day accident
           diary, quality of life measure (King's Health Questionnaire).

        -  Pelvic floor muscle function:

             -  Electromyographic study (EMG) of the pelvic floor muscles using an intravaginal
                electrode

             -  Transabdominal diagnostic ultrasound

        -  Adherence to program: self report diary.

      Subjects being assessed for pelvic floor muscle activity will attend the School of
      Physiotherapy Movement Laboratory to undertake the following tests:

        1. A 7-day accident diary

        2. King's Health Questionnaire

        3. Severity index score

        4. ICIQ SF score

        5. Ultra-sound examination of movement of the pelvic floor muscles

        6. EMG measurement of pelvic floor muscle activity.

      Ultrasound measurement using an Acoustic Imaging Performa ultrasound unit (Dornier, Medtech,
      USA) and its accompanying software will be used for imaging and measurement. The aim is to
      obtain images showing the greatest degree of displacement during pelvic floor muscle
      activity. The mean value of three recorded measurement will be used for statistical analysis
      for the following activities: 20 second maximum effort endurance hold, 3 deep coughs, 3
      huffs.

      EMG pelvic floor activity will be measured using an intravaginal electrode at rest, following
      a brief maximum voluntary contraction over 1 second and a sustained maximum voluntary
      contraction over 20 seconds to determine the strength and timing of pelvic floor muscle
      activity in subjects with chronic cough compared to healthy controls. In order to investigate
      pelvic floor muscle activity during forced expirations and coughing EMG recording will be
      recorded with thoracic movement during huffing and coughs and during the preceding
      inspiration.

      The effects of a physiotherapeutic intervention over a three-month period on incontinence
      will be investigated. All subjects will be referred for treatment to one of 9 selected
      continence physiotherapists working in continence clinics or women's health practices
      providing state of the art treatment conveniently located for each subject. Treatment will
      comprise standard physiotherapy interventions with up to 5 treatments within the 3-months
      period customised on the basis of the assessment. Details of treatments will subsequently be
      examined for broad consistency. Pelvic floor muscle training, biofeedback, electrotherapy and
      bladder training will be included in treatment as individually indicated.. A further
      assessment will occur immediately post-treatment program followed by a follow-up assessment
      3-months after the completion of the treatment program. Results of the study will be provided
      to medical practitioners and physiotherapists.
    

Intervention name(s): Pelvic floor training group
Intervention type(s): Procedure
Intervention description(s): pelvic floor training, electrotherapy, bladder retraining.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Incontinence; physiotherapy; treatment; pelvic floor muscle function; coughing; forced expirations; lung disease