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Trial record 20 of 697 for:    (elderly OR senior) AND incontinence AND (woman OR women OR female)

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

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ClinicalTrials.gov Identifier: NCT02614105
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Stacey Haukeland Parker, Ostfold Hospital Trust

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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Urinary Incontinence Procedure: Pelvic floor muscle training Procedure: Cough-suppression therapy Other: Control Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pelvic floor muscle training
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.
Procedure: Pelvic floor muscle training
16 weeks of group-based exercise

Experimental: Cough-suppression
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
Procedure: Cough-suppression therapy
Group and individual sessions of respiratory physiotherapy with focus on techniques to suppress cough

Experimental: Control group
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.
Other: Control
Brief information only




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614105


Contacts
Contact: Stacey Haukeland-Parker, MSc stapar@so-hf.no
Contact: Hege Hølmo Johannessen, PhD xegjoh@so-hf.no

Locations
Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Stacey Haukeland-Parker, MSc       stapar@so-hf.no   
Contact: Hege Hølmo Johannessen, PhD       xegjoh@so-hf.no   
Østfold Hospital Trust Recruiting
Moss, Østfold, Norway
Contact: Stacey Haukeland-Parker, MSc    004769866630    stapar@so-hf.no   
Contact: Hege Hølmo Johannessen, PhD       xegjoh@so-hf.no   
Sponsors and Collaborators
Ostfold Hospital Trust
St. Olavs Hospital
Investigators
Principal Investigator: Hege Hølmo Johannessen, PhD Ostfold Hospital

Responsible Party: Stacey Haukeland Parker, MSc/senior physiotherapist, Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT02614105     History of Changes
Other Study ID Numbers: 3342
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Urinary Incontinence
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Enuresis
Respiratory Tract Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders