Stress Urinary Incontinence (SUI)NCT07009249
Dynamic Neuromuscular Stabilization Exercises in Women With Urinary Incontinence
A study testing Pelvic floor muscle training and Dynamic neuromuscular stabilization in people with Stress Urinary Incontinence (SUI) and Dynamic Neuromuscular Stabilization, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
Stress urinary incontinence (SUI) is defined by the International Continence Society as the complaint of involuntary leakage of urine during physical exertion, including sports activities, or during sneezing or coughing. Read more about this study
- Who is it for?
- Ages 18 to 62 years, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI), Dynamic Neuromuscular Stabilization, Pelvic Floor Muscle Training
- What is being tested?
- Pelvic floor muscle training and Dynamic neuromuscular stabilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2025to 1 Jan 2026
- 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
- Female gender,
- Voluntary participation in the study,
- Aged between 18 and 62 years,
- Ability to read and write in Turkish,
- No mental disorders that would impair cooperation or comprehension,
- Complaint of stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence.
Who cannot join
- Prior history of pelvic floor muscle training,
- Presence of any neurological disorder,
- Pelvic organ prolapse stage II or higher,
- Presence of fecal incontinence,
- Pregnancy,
- Lower extremity conditions that may affect pelvic alignment (e.g., leg length discrepancy, total hip arthroplasty),
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- Active lower urinary tract infection,
- Presence of respiratory disorders such as chronic obstructive pulmonary disease or asthma,
- History of hysterectomy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir University of Economics
Izmir, İzmir, 35330
About this study
Official title: Effects of Dynamic Neuromuscular Stabilization Exercises on Urinary Symptoms and Pelvic Floor Muscle Functions in Women With Stress Urinary Incontinence: A Single-Blind Non-Inferiority Clinical Study
Stress urinary incontinence (SUI) is defined by the International Continence Society as the complaint of involuntary leakage of urine during physical exertion, including sports activities, or during sneezing or coughing. In continent women, an automatic response-namely, a reflex pelvic floor muscle (PFM) contraction, also known as pre-contraction-occurs either prior to or during physical exertion. Although there is strong evidence supporting the effectiveness of pelvic floor muscle training (PFMT) in the treatment of SUI, there has been a growing interest in exploring alternative exercise-based interventions.
Dynamic Neuromuscular Stabilization (DNS) is a manual and rehabilitative approach developed by Professor Pavel Kolar. It is grounded in the scientific principles of developmental kinesiology and aims to optimize the function of the movement system. Currently, DNS is successfully employed in the rehabilitation of various neurological, musculoskeletal, pediatric, and sports-related injuries. DNS incorporates the subconscious and synergistic activation of the deep core muscles responsible for intra-abdominal pressure (IAP) regulation and spinal stability-namely, the diaphragm, transversus abdominis, multifidus, and pelvic floor muscles-as well as the global musculature.
Read more
Considering the potential mechanisms of DNS, we hypothesize that DNS exercises, through IAP regulation directed toward the pelvic cavity and contributing to stabilization, could serve as an effective and innovative approach for women with SUI.
The hypotheses of this study are as follows:
H1.1: DNS is as effective as PFMT in reducing urinary symptoms in women with SUI.
H1.2: DNS is as effective as PFMT in improving PFM function in women with SUI.
- Conditions
- Stress Urinary Incontinence (SUI), Dynamic Neuromuscular Stabilization, Pelvic Floor Muscle Training, Urinary Symptoms, Biofeedback Training
- Being tested
- Pelvic floor muscle training, Dynamic neuromuscular stabilization
- 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 trainingBehavioural
Women in this group will undergo pelvic floor muscle training (PFMT) using the NeuroTrac MyoPlus 4 PRO EMG biofeedback device. Prior to the training, diaphragmatic breathing will be taught to all participants in this position to facilitate relaxation and prepare for PFMT. During the training, participants will perform pelvic floor muscle contractions while observing the real-time feedback of slow and fast contractions, as well as relaxation phases, on the computer screen connected to the device. Concurrently, the physiotherapist will guide the participants with verbal cues such as "squeeze-lift-release." Participants will be instructed to avoid holding their breath, pulling in their abdomen, straining, contracting the thigh or gluteal muscles, or moving the pelvis during the exercises. The PFMT protocol will follow the principles of motor learning stages to ensure proper skill acquisition.
Dynamic neuromuscular stabilizationBehavioural
Women in this group will be instructed in exercises based on the principles of Dynamic Neuromuscular Stabilization (DNS). Prior to the exercises, intra-abdominal pressure regulation through breathing techniques will be demonstrated. In this study, the Core 360 belt with OhmTrack sensors will be used. Both breathing exercises and DNS exercises will be taught with the belt in place. In a corrected posture, participants will be instructed to gently press the abdominal wall toward the sensors and to maintain expansion of the abdominal wall during both inspiration and expiration, while keeping the spine in a neutral position. The exercise program will begin with a preparatory training phase, which includes fascial mobilizations applied to the feet and hands. DNS exercises will start with the 4.5-month supine developmental position for sagittal stabilization. As the program progresses, exercises will be advanced according to developmental kinesiology positions.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training Group (PFMT Group) | Active comparator | Women aged 18-62 who have stress or stress-dominant mixed urinary incontinence and can read and write in Turkish Receives: Behavioral: Pelvic floor muscle training |
| Dynamic Neuromuscular Stabilization Group (DNS Group) | Experimental | Women aged 18-62 who have stress or stress-dominant mixed urinary incontinence and can read and write in Turkish Receives: Behavioral: Dynamic neuromuscular stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pelvic Floor Pre-contraction during valsalva
Pre-contraction of PFM during valsalva will be evaluated with NeuroTract Myoplus 4 PRO EMG device.The assessment will be conducted as described in previous studies. Participants will be instructed as follows: "Take a deep breath in, pinch your nose with your thumb and index finger, and close your mouth. Now try to exhale against the closed airway." The reflex activity of the pelvic floor muscles will be recorded in microvolts (μV) over a 2-second interval.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
Pelvic floor muscle strength (Vaginal palpation)
Vaginal palpation method will be used to measure pelvic floor muscle strength. The Modified Oxford Scale will be used in the assessment.(0= no contraction; 1= very weak; 2= weak; 3= moderate (with lifting); 4= good (with lifting); 5= strong (with lifting))
Measured: From enrollment to the end of treatment at 8 week
Resting EMG activity
Resting tone of PFM will be evaluated with NeuroTract Myoplus 4 PRO EMG device.Resting tone is defined as vaginal resting activity, and in order to measure resting EMG electrical activity, women will be asked to remain as still as possible, not to perform voluntary PFM contraction or straining, and to maintain their most comfortable positions. After this condition is achieved, the numerical equivalent of the electrical activity occurring in the EMG probe on the monitor will be recorded as resting activity in terms of (μV).
Measured: From enrollment to the end of treatment at 8 weeks
Maximum voluntary contraction
Maximum voluntary contraction of PFM will be evaluated with NeuroTract Myoplus 4 PRO EMG device. After recording the resting EMG activity of the pelvic floor muscles, women will be asked to perform maximum voluntary contraction. Maximum voluntary contraction force (microvolts (μV)) will be automatically recorded by the device after three measurements.
Measured: From enrollment to the end of treatment at 8 weeks
Change in Urinary Incontinence Severity
The severity of urinary incontinence in women will be assessed using the Incontinence Severity Index (ISI). This index consists of two questions. Participants will be asked:
"How often do you experience urine leakage?" with response options scored as 1 (less than once a month), 2 (a few times a month), 3 (a few times a week), or 4 (every day and/or night); and "How much urine do you usually leak each time?" with options scored as 1 (a few drops), 2 (small splashes), or 3 (more).
The total score is calculated by multiplying the scores of the two items, resulting in a total score ranging from 1 to 12. Higher scores indicate more severe urinary incontinence.
Measured: From enrollment to the end of treatment at 8 weeks
Change in urinary symptoms and impact on quality of life
Urinary incontinence symptoms and their impact on quality of life will be assessed using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). The ICIQ-SF was developed by Avery et al. to evaluate urinary incontinence and its effects on quality of life. The questionnaire has been reported to have high levels of sensitivity, reliability, and validity. Only the first three domains are scored, while the fourth domain provides descriptive information that can help identify the type of urinary incontinence. Each scored domain can be analyzed independently, or the scores of the first three items can be summed to assess the overall impact of urinary incontinence on quality of life. The total score ranges from 0 to 21, with higher scores indicating greater impact on quality of life.
Measured: From enrollment to the end of treatment at 8 weeks
Change of contraction onset time
Contraction of PFM onset time will be evaluated with NeuroTract Myoplus 4 PRO EMG device. Contraction onset time (seconds) will be automatically recorded by the device after three measurements.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start21 May 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yakit Yesilyurt, Izmir University of Economics
- Investigators
- Seda Yakıt Yeşilyurt, Principal investigator, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009249
- Sponsor's protocol ID
- SYY_IEU_5
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 1 Sep 2026
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Neuromuscular Stabilization Exercises on Urinary Symptoms and Pelvic Floor Muscle Functions in Women With Stress Urinary Incontinence: A Single-Blind Non-Inferiority Clinical Study
- ClinicalTrials.gov ID
- NCT07009249
- Acronym / sponsor ID
- SYY_IEU_5
- Conditions
- Stress Urinary Incontinence (SUI), Dynamic Neuromuscular Stabilization, Pelvic Floor Muscle Training, Urinary Symptoms, Biofeedback Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 6 Jun 2025 (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.
Stress urinary incontinence (SUI) is defined by the International Continence Society as the complaint of involuntary leakage of urine during physical exertion, including sports activities, or during sneezing or coughing. In continent women, an automatic response-namely, a reflex pelvic floor muscle (PFM) contraction, also known as pre-contraction-occurs either prior to or during physical exertion. Although there is strong evidence supporting the effectiveness of pelvic floor muscle training (PFMT) in the treatment of SUI, there has been a growing interest in exploring alternative exercise-based interventions.
Dynamic Neuromuscular Stabilization (DNS) is a manual and rehabilitative approach developed by Professor Pavel Kolar. It is grounded in the scientific principles of developmental kinesiology and aims to optimize the function of the movement system. Currently, DNS is successfully employed in the rehabilitation of various neurological, musculoskeletal, pediatric, and sports-related injuries. DNS incorporates the subconscious and synergistic activation of the deep core muscles responsible for intra-abdominal pressure (IAP) regulation and spinal stability-namely, the diaphragm, transversus abdominis, multifidus, and pelvic floor muscles-as well as the global musculature.
Considering the potential mechanisms of DNS, we hypothesize that DNS exercises, through IAP regulation directed toward the pelvic cavity and contributing to stabilization, could serve as an effective and innovative approach for women with SUI.
The hypotheses of this study are as follows:
H1.1: DNS is as effective as PFMT in reducing urinary symptoms in women with SUI.
H1.2: DNS is as effective as PFMT in improving PFM function in women with SUI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training Group (PFMT Group) | Active comparator | Behavioral: Pelvic floor muscle trainingWomen aged 18-62 who have stress or stress-dominant mixed urinary incontinence and can read and write in Turkish |
| Dynamic Neuromuscular Stabilization Group (DNS Group) | Experimental | Behavioral: Dynamic neuromuscular stabilizationWomen aged 18-62 who have stress or stress-dominant mixed urinary incontinence and can read and write in Turkish |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female gender,
- Voluntary participation in the study,
- Aged between 18 and 62 years,
- Ability to read and write in Turkish,
- No mental disorders that would impair cooperation or comprehension,
Key exclusion criteria (9 listed)
- Prior history of pelvic floor muscle training,
- Presence of any neurological disorder,
- Pelvic organ prolapse stage II or higher,
- Presence of fecal incontinence,
- Pregnancy,
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 trainingWomen in this group will undergo pelvic floor muscle training (PFMT) using the NeuroTrac MyoPlus 4 PRO EMG biofeedback device. Prior to the training, diaphragmatic breathing will be taught to all participants in this position to facilitate relaxation and prepare for PFMT. During the training, participants will perform pelvic floor muscle contractions while observing the real-time feedback of slow and fast contractions, as well as relaxation phases, on the computer screen connected to the device. Concurrently, the physiotherapist will guide the participants with verbal cues such as "squeeze-lift-release." Participants will be instructed to avoid holding their breath, pulling in their abdomen, straining, contracting the thigh or gluteal muscles, or moving the pelvis during the exercises. The PFMT protocol will follow the principles of motor learning stages to ensure proper skill acquisition. | Behavioural | Pelvic Floor Muscle Training Group (PFMT Group) |
| Dynamic neuromuscular stabilizationWomen in this group will be instructed in exercises based on the principles of Dynamic Neuromuscular Stabilization (DNS). Prior to the exercises, intra-abdominal pressure regulation through breathing techniques will be demonstrated. In this study, the Core 360 belt with OhmTrack sensors will be used. Both breathing exercises and DNS exercises will be taught with the belt in place. In a corrected posture, participants will be instructed to gently press the abdominal wall toward the sensors and to maintain expansion of the abdominal wall during both inspiration and expiration, while keeping the spine in a neutral position. The exercise program will begin with a preparatory training phase, which includes fascial mobilizations applied to the feet and hands. DNS exercises will start with the 4.5-month supine developmental position for sagittal stabilization. As the program progresses, exercises will be advanced according to developmental kinesiology positions. | Behavioural | Dynamic Neuromuscular Stabilization Group (DNS Group) |
Primary outcome
Change of Pelvic Floor Pre-contraction during valsalva
Time frame: From enrollment to the end of treatment at 8 weeks
Pre-contraction of PFM during valsalva will be evaluated with NeuroTract Myoplus 4 PRO EMG device.The assessment will be conducted as described in previous studies. Participants will be instructed as follows: "Take a deep breath in, pinch your nose with your thumb and index finger, and close your mouth. Now try to exhale against the closed airway." The reflex activity of the pelvic floor muscles will be recorded in microvolts (μV) over a 2-second interval.
6 secondary outcomes
Pelvic floor muscle strength (Vaginal palpation)
Time frame: From enrollment to the end of treatment at 8 week
Resting EMG activity
Time frame: From enrollment to the end of treatment at 8 weeks
Maximum voluntary contraction
Time frame: From enrollment to the end of treatment at 8 weeks
Change in Urinary Incontinence Severity
Time frame: From enrollment to the end of treatment at 8 weeks
Change in urinary symptoms and impact on quality of life
Time frame: From enrollment to the end of treatment at 8 weeks
Change of contraction onset time
Time frame: From enrollment to the end of treatment at 8 weeks
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 1 Sep 2026.
- 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 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 and Dynamic neuromuscular stabilization in people with Stress Urinary Incontinence (SUI) and Dynamic Neuromuscular Stabilization, 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 1 Sep 2026. 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 Pre-contraction during valsalva (time frame: From enrollment to the end of treatment at 8 weeks). 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 1 Sep 2026.