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Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease (UriCO)

Primary Purpose

Chronic Obstructive Pulmonary Disease, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pelvic floor muscle training
Cough-suppression therapy
Control
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • St Olavs Hospital
  • Østfold Hospital Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Pelvic floor muscle training

Cough-suppression

Control group

Arm Description

Participants in the pelvic floor muscle training group will receive group exercise sessions (1 hour) at the physiotherapy out-patient department of the hospital once a week for 16 weeks with guidance from an experienced pelvic floor physiotherapist. The group exercise sessions will focus on pelvic floor muscle training, relaxation and breathing techniques. Participants in the pelvic floor muscle training group will also receive an individually adapted pelvic floor muscle training program for daily home use.

Participants in the cough-suppression group will receive a group education session with general information about cough-suppression therapy and advice about how to distinguish between unproductive and productive cough to enable them to perform airway clearance techniques when required. In addition, participants will receive one to two individual sessions (30-60 minutes) of cough-suppression therapy tailored to the individual needs based on symptoms and underlying disease activity

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.

Outcomes

Primary Outcome Measures

International Consultation on Incontinence Questionnaire Short form (ICIQ_SF)
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 Outcome Measures

Cough symptoms
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
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
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
Voluntary pelvic floor muscle function
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.
Pelvic floor muscle strength
Pelvic floor muscle strength will be measured using Peritron.
Field walking test
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.
Physical activity
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

Full Information

First Posted
November 16, 2015
Last Updated
March 2, 2021
Sponsor
Ostfold Hospital Trust
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02614105
Brief Title
Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease
Acronym
UriCO
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ostfold Hospital Trust
Collaborators
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor muscle training
Arm Type
Experimental
Arm Description
Participants in the pelvic floor muscle training group will receive group exercise sessions (1 hour) at the physiotherapy out-patient department of the hospital once a week for 16 weeks with guidance from an experienced pelvic floor physiotherapist. The group exercise sessions will focus on pelvic floor muscle training, relaxation and breathing techniques. Participants in the pelvic floor muscle training group will also receive an individually adapted pelvic floor muscle training program for daily home use.
Arm Title
Cough-suppression
Arm Type
Experimental
Arm Description
Participants in the cough-suppression group will receive a group education session with general information about cough-suppression therapy and advice about how to distinguish between unproductive and productive cough to enable them to perform airway clearance techniques when required. In addition, participants will receive one to two individual sessions (30-60 minutes) of cough-suppression therapy tailored to the individual needs based on symptoms and underlying disease activity
Arm Title
Control group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor muscle training
Intervention Description
16 weeks of group-based exercise
Intervention Type
Procedure
Intervention Name(s)
Cough-suppression therapy
Intervention Description
Group and individual sessions of respiratory physiotherapy with focus on techniques to suppress cough
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Brief information only
Primary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire Short form (ICIQ_SF)
Description
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.
Time Frame
Change from baseline score at 16 weeks
Secondary Outcome Measure Information:
Title
Cough symptoms
Description
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
Time Frame
Change from baseline score at 16 weeks
Title
Chronic Obstructive Pulmonary Disease symptoms
Description
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.
Time Frame
Change from baseline score at 16 weeks
Title
Self-reported function and quality of life
Description
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
Time Frame
Change from baseline score at 16 weeks
Title
Voluntary pelvic floor muscle function
Description
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.
Time Frame
Change from baseline score at 16 weeks
Title
Pelvic floor muscle strength
Description
Pelvic floor muscle strength will be measured using Peritron.
Time Frame
Change from baseline score at 16 weeks
Title
Field walking test
Description
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.
Time Frame
Change from baseline score at 16 weeks
Title
Physical activity
Description
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
Time Frame
Change from baseline score at 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hege Hølmo Johannessen, PhD
Organizational Affiliation
Ostfold Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Facility Name
Østfold Hospital Trust
City
Moss
State/Province
Østfold
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34895285
Citation
Haukeland-Parker S, Frisk B, Spruit MA, Stafne SN, Johannessen HH. Treatment of urinary incontinence in women with chronic obstructive pulmonary disease-a randomised controlled study. Trials. 2021 Dec 11;22(1):900. doi: 10.1186/s13063-021-05816-2.
Results Reference
derived

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Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease

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