Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614105
• Other study ID #: 3342
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2021
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Enuresis
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Urinary Incontinence

Intervention

Procedure:
• Pelvic floor muscle training
16 weeks of group-based exercise
• Cough-suppression therapy
Group and individual sessions of respiratory physiotherapy with focus on techniques to suppress cough

Other:
• Control
Brief information only

Locations

Country	Name	City	State
Norway	Østfold Hospital Trust	Moss	Østfold
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline score at 16 weeks
Secondary	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	Change from baseline score at 16 weeks
Secondary	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.	Change from baseline score at 16 weeks
Secondary	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	Change from baseline score at 16 weeks
Secondary	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.	Change from baseline score at 16 weeks
Secondary	Pelvic floor muscle strength	Pelvic floor muscle strength will be measured using Peritron.	Change from baseline score at 16 weeks
Secondary	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.	Change from baseline score at 16 weeks
Secondary	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	Change from baseline score at 16 weeks