Chronic Obstructive Pulmonary DiseaseUriCONCT02614105
Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease
A study testing Pelvic floor muscle training and Cough-suppression therapy in people with Chronic Obstructive Pulmonary Disease and Urinary Incontinence, run by Ostfold Hospital Trust at 2 sites in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Urinary Incontinence
- What is being tested?
- Pelvic floor muscle training and Cough-suppression therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesNorway
- Study dates
- Nov 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD grade 1-4
- Subjective urinary incontinence
- Ability to perform an active contraction of the pelvic floor muscles
Who cannot join
- Unstable COPD
- More than 4 hospital admissions due to COPD in the past twelve months
- Neurological conditions
- Previous gynecological surgery
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Østfold Hospital Trust
Moss, Østfold fylke
St Olavs Hospital
Trondheim
About this study
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
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).
Read the 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.
- Being tested
- Pelvic floor muscle training, Cough-suppression therapy, Control
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle trainingProcedure or surgery
16 weeks of group-based exercise
Cough-suppression therapyProcedure or surgery
Group and individual sessions of respiratory physiotherapy with focus on techniques to suppress cough
ControlOther
Brief information only
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle training | Experimental | 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. Receives: Procedure: Pelvic floor muscle training |
| Cough-suppression | Experimental | 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 Receives: Procedure: Cough-suppression therapy |
| Control group | Experimental | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline score at 16 weeks
Secondary outcomes (7)
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
Measured: Change from baseline score at 16 weeks
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.
Measured: Change from baseline score at 16 weeks
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
Measured: Change from baseline score at 16 weeks
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.
Measured: Change from baseline score at 16 weeks
Pelvic floor muscle strength
Pelvic floor muscle strength will be measured using Peritron.
Measured: Change from baseline score at 16 weeks
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.
Measured: Change from baseline score at 16 weeks
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
Measured: Change from baseline score at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Principal investigator, Stacey Haukeland Parker, Ostfold Hospital Trust
- Investigators
- Hege Hølmo Johannessen, PhD, Principal investigator, Ostfold Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614105
- Sponsor's protocol ID
- 3342
- Acronym
- UriCO
- Status last verified
- Mar 2021
- First submitted
- 16 Nov 2015
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34895285
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02614105
- Acronym / sponsor ID
- UriCO / 3342
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Nov 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training | Experimental | Procedure: Pelvic floor muscle trainingParticipants 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. |
| Cough-suppression | Experimental | Procedure: Cough-suppression therapyParticipants 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 |
| Control group | Experimental | Other: ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD grade 1-4
- Subjective urinary incontinence
- Ability to perform an active contraction of the pelvic floor muscles
Key exclusion criteria (4 listed)
- Unstable COPD
- More than 4 hospital admissions due to COPD in the past twelve months
- Neurological conditions
- Previous gynecological surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle training16 weeks of group-based exercise | Procedure or surgery | Pelvic floor muscle training |
| Cough-suppression therapyGroup and individual sessions of respiratory physiotherapy with focus on techniques to suppress cough | Procedure or surgery | Cough-suppression |
| ControlBrief information only | Other | Control group |
Primary outcome
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.
7 secondary outcomes
Cough symptoms
Time frame: Change from baseline score at 16 weeks
Chronic Obstructive Pulmonary Disease symptoms
Time frame: Change from baseline score at 16 weeks
Self-reported function and quality of life
Time frame: Change from baseline score at 16 weeks
Voluntary pelvic floor muscle function
Time frame: Change from baseline score at 16 weeks
Pelvic floor muscle strength
Time frame: Change from baseline score at 16 weeks
Field walking test
Time frame: Change from baseline score at 16 weeks
Physical activity
Time frame: Change from baseline score at 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 34895285Haukeland-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hege Hølmo Johannessen, PhD principal investigator
Ostfold Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training and Cough-suppression therapy in people with Chronic Obstructive Pulmonary Disease and Urinary Incontinence, run by Ostfold Hospital Trust at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Questionnaire Short form (ICIQ_SF) (time frame: Change from baseline score at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02614105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.