Clinical trial NCT02614105: Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease
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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Urinary Incontinence
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2015-11-25
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire Short form (ICIQ_SF)
timeFrame: Change from baseline score at 16 weeks
Secondary outcomes:
measure: Cough symptoms
timeFrame: Change from baseline score at 16 weeks
measure: Chronic Obstructive Pulmonary Disease symptoms
timeFrame: Change from baseline score at 16 weeks
measure: Self-reported function and quality of life
timeFrame: Change from baseline score at 16 weeks
measure: Voluntary pelvic floor muscle function
timeFrame: Change from baseline score at 16 weeks
measure: Pelvic floor muscle strength
timeFrame: Change from baseline score at 16 weeks
measure: Field walking test
timeFrame: Change from baseline score at 16 weeks
measure: Physical activity
timeFrame: Change from baseline score at 16 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Moss
country: Norway
facility: Østfold Hospital Trust
state: Østfold
Study officials:
affiliation: Ostfold Hospital
name: Hege Hølmo Johannessen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.