Urinary IncontinenceNCT06337240
Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease
An observational study of Urinary Incontinence, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Pelvic floor on COPD patients and Pilates exercises on COPD patients
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Mar 2024to 2 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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),
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- Severe arterial hypertension,
- Neurological disorders that will affect pelvic floor muscles.
- Acute COPD exacerbation within the last 4 weeks.
- Any need for supplemental oxygen.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Cairo
Donia El masry, doctorate, 01005587119, donia.elmasry@cu.edu.eg
About this study
The aim of the study is To compare between the effect of both pelvic floor and Pilates exercises on urinary incontinences in COPD patients.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Pelvic floor on COPD patients, Pilates exercises on COPD patients
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor on COPD patientsOther
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 patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor exercises on COPD patients | 30 COPD female patients with urinary incontinence will receive pelvic floor exercises. Receives: Other: Pelvic floor on COPD patients; Other: Pilates exercises on COPD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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
Measured: 3 months
Secondary outcomes (4)
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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(
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start29 Mar 2024 (estimated)
- Primary completion2 Jul 2024 (estimated)
- Study completion2 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Ayman, Cairo University
- Investigators
- Donia El Masry, Doctorate, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337240
- Sponsor's protocol ID
- pelvic floor exercise
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20025020
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06337240
- Acronym / sponsor ID
- pelvic floor exercise
- Conditions
- Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Mar 2024 (estimated)
- Primary completion
- 2 Jul 2024 (estimated)
- Study completion
- 2 Jul 2024 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor exercises on COPD patients | – | Other: Pelvic floor on COPD patients, Other: Pilates exercises on COPD patients30 COPD female patients with urinary incontinence will receive pelvic floor exercises. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Gynecologic surgery ( 6 months prior to study)
- Current urinary tract infection
- Uncontrolled Diabetes Mellitus
- Diagnosed with psychiatric or depressive disorder
- Existing arterial aneurysm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor on COPD patientsGroup 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. | Other | Pelvic floor exercises on COPD patients |
| Pilates exercises on COPD patientsGroup 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. | Other | Pelvic floor exercises on COPD patients |
Primary outcome
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
4 secondary outcomes
Urinary incontinence quality of life questionnaire (I-QOL)
Time frame: 3 months
Cough symptoms score
Time frame: 3 months
Cough symptoms questionnaire
Time frame: 3 months
The COPD Assessment Tool (CAT)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 20025020Abrams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donia El Masry, Doctorate study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana Ali, Master (01016157507, doctorranaaymanpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary incontinence (1 Hour and 24- Hour pad test) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06337240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.