Clinical trial NCT06337240: Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease
Official title: Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Incontinence
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group A (study group) :

This group will include 30 COPD patients with urinary incontinence , who will receive pelvic floor exercise for 3 days a week for a total of 3 months.

Group B (study group):

This group will include 30 COPD patients with urinary incontinence , who will receive Pilates for 3 days a week for a total 3 months.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urinary incontinence (1 Hour and 24- Hour pad test)
timeFrame: 3 months
measure: Incontinence severity index:
timeFrame: 3 months
Secondary outcomes:
measure: Urinary incontinence quality of life questionnaire (I-QOL)
timeFrame: 3 months
measure: Cough symptoms score
timeFrame: 3 months
measure: Cough symptoms questionnaire
timeFrame: 3 months
measure: The COPD Assessment Tool (CAT)
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Cairo University
name: Donia El Masry, Doctorate
role: STUDY_DIRECTOR
References:
citation: Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D, Nitti V, Norton C, Nygaard I, Payne C, Smith A, Staskin D, Tekgul S, Thuroff J, Tubaro A, Vodusek D, Wein A, Wyndaele JJ; Members of Committees; Fourth International Consultation on Incontinence. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40. doi: 10.1002/nau.20870. No abstract available.