Chronic Obstructive Pulmonary Disease, Urinary Incontinence
Conditions
Brief summary
The primary aim of the study is to investigate whether pelvic floor muscle training or cough-suppression therapy reduces symptoms of urinary incontinence amongst women with chronic obstructive pulmonary disease grade 1-4 (mild to very severe disease).
Detailed description
This two-centre study will consist of a randomised controlled trial (RCT) with a parallel group design and include two intervention groups and one control group. Recruitment and data collection will occur simultaneously at the ØHT and St. Olav's Hospital in Trondheim. All participants will complete an initial four week general group exercise class (1 hour once a week) prior to randomisation. This intervention will focus on strength exercises (lower limb and upper limb), endurance training, balance training and thorax mobilising exercises. All participants will be examined and complete questionnaires at two occasions; after the initial four weeks general exercise/before intervention, and at 16 weeks post-randomisation. Participants will be randomised to either Intervention group A (pelvic floor muscle training group), Intervention group B (cough-suppression group) or a control group who will receive brief written information about pelvic floor muscle training and cough-suppression, but no other form of regular follow-up or intervention throughout the intervention period.
Interventions
PROCEDUREPelvic floor muscle training
16 weeks of group-based exercise
PROCEDURECough-suppression therapy
Group and individual sessions of respiratory physiotherapy with focus on techniques to suppress cough
OTHERControl
Brief information only
Sponsors
St. Olavs Hospital
Ostfold Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COPD grade 1-4 * Subjective urinary incontinence * Ability to perform an active contraction of the pelvic floor muscles
Exclusion criteria
* Unstable COPD * More than 4 hospital admissions due to COPD in the past twelve months * Neurological conditions * Previous gynecological surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Consultation on Incontinence Questionnaire Short form (ICIQ_SF) | Change from baseline score at 16 weeks | Participants in the group will receive guidance and instruction in terms of correct contraction of the pelvic floor muscles at clinical assessment. Control group participants will receive brief written information about pelvic floor muscle training and cough-suppression therapy, but no other form of regular follow-up or intervention throughout the intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cough symptoms | Change from baseline score at 16 weeks | Cough symptoms will be measured using the Norwegian version of the Leicester Cough Questionnaire, which is in the process of being translated from English to Norwegian and tested for reliability and validity. The Leicester Cough Questionnaire is used to measure physical, psychological and social factors related to cough |
| Chronic Obstructive Pulmonary Disease symptoms | Change from baseline score at 16 weeks | A subjective evaluation of their Chronic Obstructive Pulmonary Disease symptoms (including cough) using the COPD Assessment Test (CAT). CAT is a disease-specific questionnaire which measures subjective symptoms of Chronic Obstructive Pulmonary Disease. |
| Self-reported function and quality of life | Change from baseline score at 16 weeks | COOP/WONCA is quick and easy to complete and has demonstrated good validity and reliability both in Norwegian and in the Chronic Obstructive Pulmonary Disease population |
| Field walking test | Change from baseline score at 16 weeks | Participants will also perform the six-minute walk test at inclusion and after the intervention to explore whether the intervention results in a change in general physical capacity. |
| Pelvic floor muscle strength | Change from baseline score at 16 weeks | Pelvic floor muscle strength will be measured using Peritron. |
| Physical activity | Change from baseline score at 16 weeks | Physical activity will be measured using an activity monitor (pedometer) which the participants will wear throughout the whole intervention period to investigate whether a change in urinary incontinence affects physical activity |
| Voluntary pelvic floor muscle function | Change from baseline score at 16 weeks | Voluntary pelvic floor muscle function will be evaluated using digital palpation and scored on a 1-4 scale according to the International Continence Society Score. |
Countries
Norway
Outcome results
None listed