Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease

NCT02614105 | Completed DMC

• 1 other identifier: 3342
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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).

Conditions

Chronic Obstructive Pulmonary Disease; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Cough symptoms

  Change from baseline score at 16 weeks

• Chronic Obstructive Pulmonary Disease symptoms

  Change from baseline score at 16 weeks

• Self-reported function and quality of life

  Change from baseline score at 16 weeks

• Voluntary pelvic floor muscle function

  Change from baseline score at 16 weeks

• Pelvic floor muscle strength

  Change from baseline score at 16 weeks

Study Arms (3)

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.

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

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.

Other: Control

Interventions

Pelvic floor muscle training PROCEDURE

16 weeks of group-based exercise

Pelvic floor muscle training

Cough-suppression therapy PROCEDURE

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

Cough-suppression

Control OTHER

Brief information only

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD grade 1-4
• Subjective urinary incontinence
• Ability to perform an active contraction of the pelvic floor muscles

You may not qualify if:

• Unstable COPD
• More than 4 hospital admissions due to COPD in the past twelve months
• Neurological conditions
• Previous gynecological surgery

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• St. Olavs Hospital: collaborator

Study Sites (2)

St Olavs Hospital

Trondheim, Norway

Location

Østfold Hospital Trust

Moss, Østfold fylke, Norway

Location

Related Publications (1)

• 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.

  PMID: 34895285 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Urinary Incontinence

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Hege Hølmo Johannessen, PhD

  Ostfold Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc/senior physiotherapist

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 25, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

NO (2)