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Completed

NCT Number: NCT02614105

Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Østfold Hospital Trust, Moss, Østfold fylke, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pelvic floor muscle training

Procedure

16 weeks of group-based exercise

Cough-suppression therapy

Procedure

Group and individual sessions of respiratory physiotherapy with focus on techniques to suppress cough

Control

Other

Brief information only

Primary outcomes

  1. International Consultation on Incontinence Questionnaire Short form (ICIQ_SF)

    Time frame: 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 outcomes

  1. Cough symptoms

    Time frame: 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

  2. Chronic Obstructive Pulmonary Disease symptoms

    Time frame: 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.

  3. Self-reported function and quality of life

    Time frame: 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

  4. Voluntary pelvic floor muscle function

    Time frame: 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.

  5. Pelvic floor muscle strength

    Time frame: Change from baseline score at 16 weeks

    Pelvic floor muscle strength will be measured using Peritron.

  6. Field walking test

    Time frame: 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.

  7. Physical activity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

UriCO - Effect of Pelvic Floor Muscle Training and Cough-suppression Therapy on Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease; a Randomised Controlled Trial

Acronym: UriCO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 25, 2015
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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