Stress Urinary IncontinenceNCT06120699
360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence
A study testing Pelvic floor muscle training with 360 degree expanded diaphragm exercises and Pelvic floor muscle training with standard diaphragm exercises in people with Stress Urinary Incontinence and Diaphragmatic Breathing, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine and compare the effects of standard diaphragm exercises with Pelvic floor muscle exercises (PFME) and 360-degree expanded diaphragm exercises with PFME on urinary symptoms, PFM functions and quality of life in women with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 62 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Diaphragmatic Breathing, Pelvic Floor Muscle Exercise
- What is being tested?
- Pelvic floor muscle training with 360 degree expanded diaphragm exercises and Pelvic floor muscle training with standard diaphragm exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Nov 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 18 to 62 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being a woman,
- Participating in the research voluntarily,
- Being between the ages of 18-62,
- Ability to read and write Turkish,
- Not having any mental problems that would prevent cooperation and understanding,
- Having a complaint of stress urinary incontinence or stress-predominant mixed urinary incontinence.
Who cannot join
- Having received pelvic floor training before,
- Having a neurological disease,
- Pelvic organ prolapse stage is stage 2 or higher,
- Having fecal incontinence,
- Being pregnant,
- Lower extremity problems that may affect the pelvic structure (conditions such as lower extremity inequality, total hip arthroplasty)
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- Having an active lower urinary tract infection,
- Having respiratory system diseases such as chronic obstructive pulmonary disease and asthma,
- Having undergone hysterectomy surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Pelvic Floor Muscle Training Including 360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence: Double-Blind Randomized Controlled Study
This study was planned to examine and compare the effects of standard diaphragm exercises with Pelvic floor muscle exercises (PFME) and 360-degree expanded diaphragm exercises with PFME on urinary symptoms, PFM functions and quality of life in women with stress urinary incontinence.
- Conditions
- Stress Urinary Incontinence, Diaphragmatic Breathing, Pelvic Floor Muscle Exercise, Intra-abdominal Pressure
- Being tested
- Pelvic floor muscle training with 360 degree expanded diaphragm exercises, Pelvic floor muscle training with standard diaphragm exercises
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training with 360 degree expanded diaphragm exercisesOther
Women in this group will be taught 360-degree expanded diaphragm exercises with the Ohmbelt device. Two Ohmbelt devices will be used in this study. The anterior sensor will be placed in the inguinal cavity to visualize the expansion of the anterior abdominal wall, and the posterior sensor will be placed contralaterally in the upper lumbar triangle to visualize the expansion of the posterior wall. The protocol of breathing exercises is inspiration and expiration time of 6 seconds, 10 repetitions and 3 sets. Pelvic floor muscle training will be given with the NeuroTract Myoplus 4 PRO EMG biofeedback device. The training protocol: Each patient will be asked to contract close to the maximum pelvic floor muscle contraction for slow muscle contraction, maintain the contraction for 6-8 seconds, and then perform fast muscle contractions 3-4 times. This cycle is 1 set, 8-12 repetitions. A total of 3 sets will be applied.
Pelvic floor muscle training with standard diaphragm exercisesOther
Women in this group will be taught standard diaphragm exercises. In the supine position, with the head and knees supported by a pillow, the patient will first be asked to close his or her eyes to focus. With one hand on the chest and the other hand on the abdomen, "Take a deep breath through your nose and direct all the air as much as possible under your lower hand. inflate your belly. Now exhale all the air slowly through your mouth." The protocol of breathing exercises is inspiration and expiration time of 6 seconds, 10 repetitions and 3 sets. Pelvic floor muscle training will be given with the NeuroTract Myoplus 4 PRO EMG biofeedback device. The training protocol: Each patient will be asked to contract close to the maximum pelvic floor muscle contraction for slow muscle contraction, maintain the contraction for 6-8 seconds, and then perform fast muscle contractions 3-4 times. This cycle is 1 set, 8-12 repetitions. A total of 3 sets will be applied.
| Study group | Role | What they receive |
|---|---|---|
| 360 Degree Expanded Diaphragm Exercises | Experimental | Volunteers who complain of urinary incontinence in situations such as coughing, sneezing and laughing, who have been diagnosed with stress or stress-predominant mixed urinary incontinence by a Gynecology and Obstetrics physician, and who meet the inclusion criteria will be included in the study. Receives: Other: Pelvic floor muscle training with 360 degree expanded diaphragm exercises |
| Standard Diaphragm Exercises | Active comparator | Volunteers who complain of urinary incontinence in situations such as coughing, sneezing and laughing, who have been diagnosed with stress or stress-predominant mixed urinary incontinence by a Gynecology and Obstetrics physician, and who meet the inclusion criteria will be included in the study. Receives: Other: Pelvic floor muscle training with standard diaphragm exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pelvic floor muscle contraction during Valsalva
Pelvic floor muscle contraction during Valsalva will be evaluated with the NeuroTract Myoplus 4 PRO EMG device. A disposable, cylindrical endovaginal probe will be used to record pelvic floor muscle electromyographic activity. The evaluation will be carried out as stated in previous studies, and the women are told: "Take as deep a breath as possible, pinch your nose with your thumb and index finger and close your mouth, try to breathe out against the now closed respiratory system." instructions will be given. For a clearer understanding, the expression "pretend to strain" will also be used. The probe will be manually supported by the investigator throughout the testing procedure to prevent the pressure probe from moving and losing contact with the PTK during evaluation. 2 seconds of reflex PFM activity will be recorded in μV.
Measured: at baseline, at 8th week
Secondary outcomes (9)
Change of urinary symptoms
The severity of women's incontinence will be questioned with the Incontinence Severity Index.
Measured: at baseline, at 8th week
Change of quality of life score
Urinary incontinence symptoms and their impact on quality of life will be evaluated with the International Urinary Incontinence Questionnaire Form.
Measured: at baseline, at 8th week
Change of Pelvic floor muscle maximum voluntary contraction
Maximum voluntary contraction of women will be evaluated with the NeuroTract Myoplus 4 PRO EMG device. A disposable, cylindrical endovaginal probe will be used to record pelvic floor muscle electromyographic activity. MVC, average peak activation results during three PFM contractions will be expressed in μV and percentage (%).
Measured: at baseline, at 8th week
Change of maximum inspiratory pressure
A non-invasive, RP Check brand electronic pressure measuring device (MD Diagnostics Ltd., Maidstone, UK) will be used to measure maximum inspiratory pressure.
Measured: at baseline, at 8th week
Change of maximum expiratory pressure
A non-invasive, RP Check brand electronic pressure measuring device (MD Diagnostics Ltd., Maidstone, UK) will be used to measure maximum expiratory pressure.
Measured: at baseline, at 8th week
Subjective perception of improvement
Women's subjective perception of improvement was assessed using the Global Perception of Improvement scale
Measured: at 8th week
Change of Social Activity Participation
The Social Activity Index will be used, in which nine social situations are selected to represent situations in which women have problems in social participation due to urinary incontinence.
Measured: at baseline, at 8th week
Change of average number of urinary incontinence
Women will be asked to complete a bladder diary reflecting the daily activity patterns of the bladder for 3 consecutive days.
Measured: at baseline, at 8th week
Change of Pelvic floor muscle strength
Vaginal palpation method will be used to measure pelvic floor muscle strength. (Modified Oxford Scale)
Measured: at baseline, at 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Jun 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Model description
- This is a prospective double-blind randomized controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Seda Yakit Yesilyurt, Izmir University of Economics
- Investigators
- Seda Yakıt Yeşilyurt, PhD, Principal investigator, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120699
- Sponsor's protocol ID
- SYY_İEÜ_2
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2023
- Last updated
- 5 Nov 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pelvic Floor Muscle Training Including 360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence: Double-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06120699
- Acronym / sponsor ID
- SYY_İEÜ_2
- Conditions
- Stress Urinary Incontinence, Diaphragmatic Breathing, Pelvic Floor Muscle Exercise, Intra-abdominal Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 7 Nov 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.
This study was planned to examine and compare the effects of standard diaphragm exercises with Pelvic floor muscle exercises (PFME) and 360-degree expanded diaphragm exercises with PFME on urinary symptoms, PFM functions and quality of life in women with stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective double-blind randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| 360 Degree Expanded Diaphragm Exercises | Experimental | Other: Pelvic floor muscle training with 360 degree expanded diaphragm exercisesVolunteers who complain of urinary incontinence in situations such as coughing, sneezing and laughing, who have been diagnosed with stress or stress-predominant mixed urinary incontinence by a Gynecology and Obstetrics physician, and who meet the inclusion criteria will be included in the study. |
| Standard Diaphragm Exercises | Active comparator | Other: Pelvic floor muscle training with standard diaphragm exercisesVolunteers who complain of urinary incontinence in situations such as coughing, sneezing and laughing, who have been diagnosed with stress or stress-predominant mixed urinary incontinence by a Gynecology and Obstetrics physician, and who meet the inclusion criteria will be included in the study. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being a woman,
- Participating in the research voluntarily,
- Being between the ages of 18-62,
- Ability to read and write Turkish,
- Not having any mental problems that would prevent cooperation and understanding,
Key exclusion criteria (9 listed)
- Having received pelvic floor training before,
- Having a neurological disease,
- Pelvic organ prolapse stage is stage 2 or higher,
- Having fecal incontinence,
- Being pregnant,
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 muscle training with 360 degree expanded diaphragm exercisesWomen in this group will be taught 360-degree expanded diaphragm exercises with the Ohmbelt device. Two Ohmbelt devices will be used in this study. The anterior sensor will be placed in the inguinal cavity to visualize the expansion of the anterior abdominal wall, and the posterior sensor will be placed contralaterally in the upper lumbar triangle to visualize the expansion of the posterior wall. The protocol of breathing exercises is inspiration and expiration time of 6 seconds, 10 repetitions and 3 sets. Pelvic floor muscle training will be given with the NeuroTract Myoplus 4 PRO EMG biofeedback device. The training protocol: Each patient will be asked to contract close to the maximum pelvic floor muscle contraction for slow muscle contraction, maintain the contraction for 6-8 seconds, and then perform fast muscle contractions 3-4 times. This cycle is 1 set, 8-12 repetitions. A total of 3 sets will be applied. | Other | 360 Degree Expanded Diaphragm Exercises |
| Pelvic floor muscle training with standard diaphragm exercisesWomen in this group will be taught standard diaphragm exercises. In the supine position, with the head and knees supported by a pillow, the patient will first be asked to close his or her eyes to focus. With one hand on the chest and the other hand on the abdomen, "Take a deep breath through your nose and direct all the air as much as possible under your lower hand. inflate your belly. Now exhale all the air slowly through your mouth." The protocol of breathing exercises is inspiration and expiration time of 6 seconds, 10 repetitions and 3 sets. Pelvic floor muscle training will be given with the NeuroTract Myoplus 4 PRO EMG biofeedback device. The training protocol: Each patient will be asked to contract close to the maximum pelvic floor muscle contraction for slow muscle contraction, maintain the contraction for 6-8 seconds, and then perform fast muscle contractions 3-4 times. This cycle is 1 set, 8-12 repetitions. A total of 3 sets will be applied. | Other | Standard Diaphragm Exercises |
Primary outcome
Change of Pelvic floor muscle contraction during Valsalva
Time frame: at baseline, at 8th week
Pelvic floor muscle contraction during Valsalva will be evaluated with the NeuroTract Myoplus 4 PRO EMG device. A disposable, cylindrical endovaginal probe will be used to record pelvic floor muscle electromyographic activity. The evaluation will be carried out as stated in previous studies, and the women are told: "Take as deep a breath as possible, pinch your nose with your thumb and index finger and close your mouth, try to breathe out against the now closed respiratory system." instructions will be given. For a clearer understanding, the expression "pretend to strain" will also be used. The probe will be manually supported by the investigator throughout the testing procedure to prevent the pressure probe from moving and losing contact with the PTK during evaluation. 2 seconds of reflex PFM activity will be recorded in μV.
9 secondary outcomes
Change of urinary symptoms
Time frame: at baseline, at 8th week
Change of quality of life score
Time frame: at baseline, at 8th week
Change of Pelvic floor muscle maximum voluntary contraction
Time frame: at baseline, at 8th week
Change of maximum inspiratory pressure
Time frame: at baseline, at 8th week
Change of maximum expiratory pressure
Time frame: at baseline, at 8th week
Subjective perception of improvement
Time frame: at 8th week
Change of Social Activity Participation
Time frame: at baseline, at 8th week
Change of average number of urinary incontinence
Time frame: at baseline, at 8th week
Change of Pelvic floor muscle strength
Time frame: at baseline, at 8th 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 5 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Seda Yakıt Yeşilyurt, PhD principal investigator
Izmir University of Economics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training with 360 degree expanded diaphragm exercises and Pelvic floor muscle training with standard diaphragm exercises in people with Stress Urinary Incontinence and Diaphragmatic Breathing, run by Izmir University of Economics at 1 site 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 6 inclusion and 9 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 5 Nov 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 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?
Change of Pelvic floor muscle contraction during Valsalva (time frame: at baseline, at 8th week). 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 5 Nov 2024.