Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease

NCT ID: NCT02614105

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pelvic floor muscle training

Intervention Type: PROCEDURE

16 weeks of group-based exercise

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

Group Type: EXPERIMENTAL

Cough-suppression therapy

Intervention Type: PROCEDURE

Group and individual sessions of respiratory physiotherapy with focus on techniques to suppress cough

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.

Group Type: EXPERIMENTAL

Control

Intervention Type: OTHER

Brief information only

Interventions

Pelvic floor muscle training

16 weeks of group-based exercise

Intervention Type: PROCEDURE

Cough-suppression therapy

Group and individual sessions of respiratory physiotherapy with focus on techniques to suppress cough

Intervention Type: PROCEDURE

Control

Brief information only

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Stacey Haukeland Parker

MSc/senior physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hege Hølmo Johannessen, PhD

Role: PRINCIPAL_INVESTIGATOR

Ostfold Hospital

Locations

St Olavs Hospital

Trondheim, , Norway

Østfold Hospital Trust

Moss, Østfold fylke, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 34895285 (View on PubMed)

Other Identifiers

3342

Identifier Type: -

Identifier Source: org_study_id