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Clinical Trials/NCT06337240
NCT06337240RecruitingNot Applicable

Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease

Cairo University1 site in 1 country60 target enrollmentStarted: March 29, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Urinary incontinence (1 Hour and 24- Hour pad test)

Study Overview

Brief Summary

The aim of the study is To compare between the effect of both pelvic floor and Pilates exercises on urinary incontinences in COPD patients.

Detailed Description

Urinary incontinence (UI) is defined as loss of bladder control and is characterized by the complaint of any involuntary leakage of urine UI is an important individual and social problem, in that it is associated with worse health-related quality of life (HRQoL) in subjects with chronic obstructive pulmonary disease. Although UI is not a life-threatening condition, it is common and can have numerous negative psychological, social, and economical effects. Women with UI in the general population have higher levels of depression, anxiety and stress, poor sleep quality and significantly lower HRQL Additionally, long term UI may result in absence from work, increased healthcare costs, social isolation and physical inactivity which is common from the early stages of the COPD due to dyspnea. Furthermore, inactivity is associated with risk of hospital admissions and is a strong predictor for mortality. The combination of UI and COPD may therefore result in a double risk factor in terms of exercise avoidance and the subsequent negative consequences of inactivity.

As it could be concluded that urinary incontinence is a trouble problem that can change the life of COPD patients and therapy attempts to prevent it or control it will be appreciated, taking in consideration that all people nowadays prefer to choose the most safe method of their conditions.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients diagnosed with COPD & Urinary incontinence
  • Stable with moderate to severe COPD
  • Their ages will range from fifty years old.
  • All patients will be clinically stable.

Exclusion Criteria

  • Gynecologic surgery ( 6 months prior to study)
  • Current urinary tract infection
  • Uncontrolled Diabetes Mellitus
  • Diagnosed with psychiatric or depressive disorder
  • Existing arterial aneurysm.
  • Clinical signs of unstable cardiac event (eg, congestive heart failure),
  • Severe arterial hypertension,
  • Neurological disorders that will affect pelvic floor muscles.
  • Acute COPD exacerbation within the last 4 weeks.
  • Any need for supplemental oxygen.

Outcomes

Primary Outcomes

Urinary incontinence (1 Hour and 24- Hour pad test)

Time Frame: 3 months

Pad testing is a non-invasive method of detecting and quantifying severity of urine leakage in men or women.

Incontinence severity index:

Time Frame: 3 months

Incontinence Severity Index (ISI), consisting of two questions regarding frequency (four levels) and amount (three levels) of leakage. The validity of the ISI has been demonstrated for different types of UI and has received the highest recommendation from the 2nd and 3rd International Consultation on Incontinence

Secondary Outcomes

  • Cough symptoms questionnaire(3 months)
  • The COPD Assessment Tool (CAT)(3 months)
  • Urinary incontinence quality of life questionnaire (I-QOL)(3 months)
  • Cough symptoms score(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rana Ayman

physiotherapist

Cairo University

Study Sites (1)

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