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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06337240
• Other study ID #: pelvic floor exercise
• Status: Recruiting
• Start date: March 29, 2024
• Est. completion date: July 2, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: Rana Ali, Master
• Phone: 01016157507
• Email: doctorranaaymanpt[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2, 2024
• Est. primary completion date: July 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Urinary Incontinence

Intervention

Other:
• Pelvic floor on COPD patients
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.
• Pilates exercises on COPD patients
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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary incontinence (1 Hour and 24- Hour pad test)	Pad testing is a non-invasive method of detecting and quantifying severity of urine leakage in men or women.	3 months
Primary	Incontinence severity index:	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	3 months
Secondary	Urinary incontinence quality of life questionnaire (I-QOL)	Incontinence Quality of Life (I-QOL), a condition-specific instrument designed to measure the QOL effects of UI in women. The I-QOL contains 22 items with a 5-point Likert-type response scale yielding a total score and three subscale scores (i.e., avoidance and limiting behaviors, psychosocial impacts, and social embarrassment) with good to excellent test-retest reliability	3 months
Secondary	Cough symptoms score	its reliability and treatment response have been confirmed The CSS is a two-part questionnaire referring to daytime and night-time symptoms. Based on the frequency, intensity and influence of cough on daily activities and sleep, cough symptoms are scored from 0 to 5, with 0 indicating no cough and 5 indicating the most severe cough	3 months
Secondary	Cough symptoms questionnaire	It is a questionnaire consisting of 19 items, including 8 physical items, 7 psychological items and 4 social items. Each item is rated according to the frequency of occurrence with a score ranging from 1 to 7. The regional score is the sum of items scored divided by the items (score 1-7) in each area; the total score is the sum of the regional scores.The lower the score, the more serious the impact of chronic cough un quality of life	3 months
Secondary	The COPD Assessment Tool (CAT)	This COPD-specific questionnaire evaluates the overall burden in subjects with COPD using 8 different questions. Each question can be scored from 0 points (not impaired) to 5 points (maximally impaired). Accordingly, the total score can range from 0 to 40 points, with higher scores reflecting greater burden of the disease.; CAT questionnaire consisting of eight questions regarding cough, phlegm, chest tightness, breathlessness during activities, activity limitations at home, confidence in leaving home, sleep and energy. The scoring range of each item is between 0 and 5, with a maximum score of 40.; According to the total CAT scores, the patients were included in the following stages: Stage 1: <10 Stage 2: 10-20 Stage 3: >20 Stage 4: >30(	3 months