Urinary IncontinenceNCT06054724
Yoga and Pilates Based Respiratory Training Effect for Individuals with Urinary Incontinence
A study testing Yoga-Based Respiration Training and Pilates-Based Respiration Training in people with Urinary Incontinence, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
The aim of the study is to examine and compare the effects of yoga-based and pilates-based respiratory training on incontinence severity, pelvic floor muscle function and quality of life in the rehabilitation of individuals with urinary incontinence. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Yoga-Based Respiration Training and Pilates-Based Respiration Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Aug 2023to 30 Jul 2024
- Phase
- Interventional
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having the diagnosis of stress or mixed urinary incontinence.
- Being volunteer to participate in the study.
- Having planned routine treatment program and being compliant with treatment
- Having no obstacles for the planned assessments.
- People who capable of written, verbal and visual communication
Who cannot join
- Having received treatment for urinary incontinence in the last 3 months.
- Using medication for vaginal or urinary tract infections.
- Pregnancy.
- Being within the first 3 years postpartum.
- Presence of concurrent pulmonary, neurological, rheumatological, or musculoskeletal disorders affecting spinal alignment.
- History of surgery that may impede the exercise planned within the scope of the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Basaksehir Cam ve Sakura City Hospital
Istanbul, Basaksehir
Istanbul University-Cerrahpasa
Istanbul, Buyukcekmece, 34500
About this study
Official title: Comparison of Yoga-Based and Pilates-Based Respiratory Training Effect for Individuals with Urinary Incontinence
The aim of the study is to examine and compare the effects of yoga-based and pilates-based respiratory training on incontinence severity, pelvic floor muscle function and quality of life in the rehabilitation of individuals with urinary incontinence.
Read the detailed description
In the literature, it has been stated that the pelvic floor alone does not play a singular role in maintaining continence, but rather forms a functional unit with the diaphragm, abdominal, and spinal muscles. Since the inability of any of these structures to perform their function properly negatively affects the function of the others, normalization and optimal functioning of the pelvic floor-thoracic diaphragm relationship are crucial in individuals with urinary incontinence. This study aims to investigate the effectiveness of yoga and Pilates approaches, considering breath as a fundamental building block, through respiration-based training programs in women with urinary incontinence.
The participants who volunteered to take part in the study will be randomly divided into two groups, namely the Yoga-based Respiration Group (Group 1) and the Pilates-based Respiration Group (Group 2), using a computer-assisted randomization program. After the groups are assigned, the initial three sessions for both groups will be conducted face-to-face under the guidance of a physiotherapist to ensure the correct execution of the exercises. The exercise program for both groups will consist of approximately 20-minute sessions, with two sessions per day, five days a week, for a total of six weeks. On the days when face-to-face sessions are held, one session will be conducted in-person, while the other session will be performed at home. During the 3rd and 5th weeks, the exercises will be progressively intensified for both groups to ensure progression, and patients will be called for face-to-face sessions. At the end of the six weeks, patients will undergo face-to-face evaluations once again.
- Conditions
- Urinary Incontinence
- Being tested
- Yoga-Based Respiration Training, Pilates-Based Respiration Training
- Keywords
- urinary incontinence, yoga, pilates, respiratory training
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga-Based Respiration TrainingOther
The selected asanas, believed to be beneficial for urinary incontinence, will be practiced with a focus on breath. After the assessment session, participants will engage in three days of face-to-face yoga sessions. On the days when face-to-face sessions are held, participants will perform the second session on their own at home. The exercises will be progressively intensified during the 3rd and 5th weeks to ensure progression. The exercise program will be conducted at home, with approximately 20-minute sessions, twice a day, five days a week, for a total of 6 weeks.
Pilates-Based Respiration TrainingOther
Before starting the 6-week practice protocol, participants will be taught the transversus abdominis muscle activation and centering, pilates-specific lateral costal breathing and other key elements of pilates. Pilates exercises chosen as beneficial for urinary incontinence will be performed with a focus on breath. After the assessment session, participants will engage in three days of face-to-face pilates sessions. On the days when face-to-face sessions are held, participants will perform the second session on their own at home. The exercises will be progressively intensified during the 3rd and 5th weeks to ensure progression. The exercise program will be conducted at home, with approximately 20-minute sessions, twice a day, five days a week, for a total of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Yoga-based Respiration Group | Experimental | This group will be given yoga-based breathing exercises Receives: Other: Yoga-Based Respiration Training |
| Pilates-based Respiration Group | Experimental | This group will be given pilates-based breathing exercises Receives: Other: Pilates-Based Respiration Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is used to measure the severity of incontinence. This form includes questions about the frequency and amount of urinary incontinence, its effect on daily life and the causes of urinary incontinence, and an evaluation is made for the last 4 weeks. It is calculated by summing the scores of the 3 dimensions in the test, and a result in the range of 0-21 points is obtained.
Measured: baseline and post-intervention (7th week)
24-Hour Pad Test
24-hour pad test The 24-Hour Pad Test is an objective evaluation method used to determine the severity of urinary incontinence. Patients are asked to start the test with an empty bladder. It is requested that the used pad should be changed every 4-6 hours and kept in a locked bag until it is taken to the hospital. Patients use the same type of pad throughout the test and are asked to bring an unused pad of the same type when coming to the hospital. The amount of urinary incontinence is calculated by subtracting the weight of the clean pad from the weight of the pads accumulated within 24 hours. It is classified as 4-20 g mild, 21-74 g moderate, >75 g severe urinary incontinence.
Measured: baseline and post-intervention (7th week)
PFM Function- MyoPlusPro EMG Device
Pelvic floor muscle function will be evaluated with electromyographic measurement (EMG). Before the test, participants will be asked to empty their bladders and will be taught to contract and relax the isolated pelvic floor muscle. Surface active electrodes will be placed to the right and left of the perineal body, and they will be asked to make 5 maximal contractions and 5 relaxations, and the obtained values will be recorded in μV.
Measured: baseline and post-intervention (7th week)
Incontinence Quality of Life Questionnaire (I-QOL)
Incontinence Quality of Life Questionnaire (I-QOL) includes questions that examine limitation of behavior, psychosocial influence and social isolation. Questions are scored between 1 and 5, and high scores indicate good quality of life.
Measured: baseline and post-intervention (7th week)
Incontinence Impact Questionnaire Short Form (IIQ-7)
The Incontinence Impact Questionnaire (IIQ-7) is used to measure the impact of urinary incontinence on individuals' daily and social lives and participation. The survey contains 7 questions, each question is scored between 1 and 4. High scores indicate negative impact.
Measured: baseline and post-intervention (7th week)
Secondary outcomes (2)
Core Muscle Endurance Assessment
The endurance of the core muscles will be evaluated with the McGill Core Endurance Test Battery. The test has 4 stages; Trunk Flexor Endurance Test Lateral Flexor Endurance Test Trunk Extensor Endurance Test
Measured: baseline and post-intervention (7th week)
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) assessment
Maximum inspiratory pressure (MIB) and maximum expiratory pressure (MEP) measurements will be made to assess respiratory function. During the MIB measurement, the participant is asked to make a maximal expiration and maximally inhale at the end of the expiration, and during the MEP measurement, to make a maximal inspiration and then a maximal expiration. Each measurement is repeated 3 times and the best value is recorded.
Measured: baseline and post-intervention (7th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start7 Aug 2023
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şevval Zeynep Girit, Istanbul University - Cerrahpasa
- Investigators
- Sevval Z Girit, Principal investigator, Istanbul University - CerrahpasaIpek Yeldan, Prof., Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054724
- Sponsor's protocol ID
- IstanbulUCSZG
- Status last verified
- May 2024
- First submitted
- 19 Sep 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Yoga-Based and Pilates-Based Respiratory Training Effect for Individuals with Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06054724
- Acronym / sponsor ID
- IstanbulUCSZG
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, yoga, pilates, respiratory training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 26 Sep 2023 (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 examine and compare the effects of yoga-based and pilates-based respiratory training on incontinence severity, pelvic floor muscle function and quality of life in the rehabilitation of individuals with urinary incontinence.
Detailed description
In the literature, it has been stated that the pelvic floor alone does not play a singular role in maintaining continence, but rather forms a functional unit with the diaphragm, abdominal, and spinal muscles. Since the inability of any of these structures to perform their function properly negatively affects the function of the others, normalization and optimal functioning of the pelvic floor-thoracic diaphragm relationship are crucial in individuals with urinary incontinence. This study aims to investigate the effectiveness of yoga and Pilates approaches, considering breath as a fundamental building block, through respiration-based training programs in women with urinary incontinence.
The participants who volunteered to take part in the study will be randomly divided into two groups, namely the Yoga-based Respiration Group (Group 1) and the Pilates-based Respiration Group (Group 2), using a computer-assisted randomization program. After the groups are assigned, the initial three sessions for both groups will be conducted face-to-face under the guidance of a physiotherapist to ensure the correct execution of the exercises. The exercise program for both groups will consist of approximately 20-minute sessions, with two sessions per day, five days a week, for a total of six weeks. On the days when face-to-face sessions are held, one session will be conducted in-person, while the other session will be performed at home. During the 3rd and 5th weeks, the exercises will be progressively intensified for both groups to ensure progression, and patients will be called for face-to-face sessions. At the end of the six weeks, patients will undergo face-to-face evaluations once again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga-based Respiration Group | Experimental | Other: Yoga-Based Respiration TrainingThis group will be given yoga-based breathing exercises |
| Pilates-based Respiration Group | Experimental | Other: Pilates-Based Respiration TrainingThis group will be given pilates-based breathing exercises |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having the diagnosis of stress or mixed urinary incontinence.
- Being volunteer to participate in the study.
- Having planned routine treatment program and being compliant with treatment
- Having no obstacles for the planned assessments.
- People who capable of written, verbal and visual communication
Key exclusion criteria (6 listed)
- Having received treatment for urinary incontinence in the last 3 months.
- Using medication for vaginal or urinary tract infections.
- Pregnancy.
- Being within the first 3 years postpartum.
- Presence of concurrent pulmonary, neurological, rheumatological, or musculoskeletal disorders affecting spinal alignment.
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 |
|---|---|---|
| Yoga-Based Respiration TrainingThe selected asanas, believed to be beneficial for urinary incontinence, will be practiced with a focus on breath. After the assessment session, participants will engage in three days of face-to-face yoga sessions. On the days when face-to-face sessions are held, participants will perform the second session on their own at home. The exercises will be progressively intensified during the 3rd and 5th weeks to ensure progression. The exercise program will be conducted at home, with approximately 20-minute sessions, twice a day, five days a week, for a total of 6 weeks. | Other | Yoga-based Respiration Group |
| Pilates-Based Respiration TrainingBefore starting the 6-week practice protocol, participants will be taught the transversus abdominis muscle activation and centering, pilates-specific lateral costal breathing and other key elements of pilates. Pilates exercises chosen as beneficial for urinary incontinence will be performed with a focus on breath. After the assessment session, participants will engage in three days of face-to-face pilates sessions. On the days when face-to-face sessions are held, participants will perform the second session on their own at home. The exercises will be progressively intensified during the 3rd and 5th weeks to ensure progression. The exercise program will be conducted at home, with approximately 20-minute sessions, twice a day, five days a week, for a total of 6 weeks. | Other | Pilates-based Respiration Group |
Primary outcome
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Time frame: baseline and post-intervention (7th week)
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is used to measure the severity of incontinence. This form includes questions about the frequency and amount of urinary incontinence, its effect on daily life and the causes of urinary incontinence, and an evaluation is made for the last 4 weeks. It is calculated by summing the scores of the 3 dimensions in the test, and a result in the range of 0-21 points is obtained.
24-Hour Pad Test
Time frame: baseline and post-intervention (7th week)
24-hour pad test The 24-Hour Pad Test is an objective evaluation method used to determine the severity of urinary incontinence. Patients are asked to start the test with an empty bladder. It is requested that the used pad should be changed every 4-6 hours and kept in a locked bag until it is taken to the hospital. Patients use the same type of pad throughout the test and are asked to bring an unused pad of the same type when coming to the hospital. The amount of urinary incontinence is calculated by subtracting the weight of the clean pad from the weight of the pads accumulated within 24 hours. It is classified as 4-20 g mild, 21-74 g moderate, >75 g severe urinary incontinence.
PFM Function- MyoPlusPro EMG Device
Time frame: baseline and post-intervention (7th week)
Pelvic floor muscle function will be evaluated with electromyographic measurement (EMG). Before the test, participants will be asked to empty their bladders and will be taught to contract and relax the isolated pelvic floor muscle. Surface active electrodes will be placed to the right and left of the perineal body, and they will be asked to make 5 maximal contractions and 5 relaxations, and the obtained values will be recorded in μV.
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: baseline and post-intervention (7th week)
Incontinence Quality of Life Questionnaire (I-QOL) includes questions that examine limitation of behavior, psychosocial influence and social isolation. Questions are scored between 1 and 5, and high scores indicate good quality of life.
Incontinence Impact Questionnaire Short Form (IIQ-7)
Time frame: baseline and post-intervention (7th week)
The Incontinence Impact Questionnaire (IIQ-7) is used to measure the impact of urinary incontinence on individuals' daily and social lives and participation. The survey contains 7 questions, each question is scored between 1 and 4. High scores indicate negative impact.
2 secondary outcomes
Core Muscle Endurance Assessment
Time frame: baseline and post-intervention (7th week)
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) assessment
Time frame: baseline and post-intervention (7th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
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Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
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RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
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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.
Sevval Z Girit principal investigator
Istanbul University - Cerrahpasa
Ipek Yeldan, Prof. study chair
Istanbul University - Cerrahpasa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga-Based Respiration Training and Pilates-Based Respiration Training in people with Urinary Incontinence, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) (time frame: baseline and post-intervention (7th week)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2024; AzTrials last refreshed its copy on 3 Nov 2026.