Stress Urinary Incontinence (SUI)DYNA-SUINCT07075900
Dynamic Neuromuscular Stabilization vs Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
A study testing Dynamic Neuromuscular Stabilization Training and Pelvic Floor Muscle Training in people with Stress Urinary Incontinence (SUI) and Dynamic Neuromuscular Stabilization, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the pre- and post-treatment effects of Dynamic Neuromuscular Stabilization (DNS) training and Pelvic Floor Muscle Training (PFMT) on pelvic floor muscle function, pelvic floor morphometry, urinary symptoms, quality of life, sexual function, and physical activity levels… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI), Dynamic Neuromuscular Stabilization, Pelvic Floor Muscle Training
- What is being tested?
- Dynamic Neuromuscular Stabilization Training and Pelvic Floor Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2025to 30 Dec 2026
- Phase
- Interventional
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged between 18 and 65 years
- Diagnosed with stress urinary incontinence or stress-dominant mixed urinary incontinence by a specialist physician
- Having the ability to voluntarily contract the pelvic floor muscles
- Literate in Turkish
- Willing and voluntarily consenting to participate in the study
Who cannot join
- Pregnancy
- Presence of urgency-predominant urinary incontinence symptoms or fecal incontinence
- Inability to understand or cooperate with assessment procedures
- Presence of any neurological or rheumatological disease
- Severe cardiac or pulmonary disease
- Uncontrolled diabetes mellitus or hypertension
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- Chronic liver and/or kidney failure
- Advanced pelvic organ prolapse (greater than grade 2)
- History of abdominal or pelvic surgery (including cesarean section) within the past year
- History of spinal surgery
- Current urinary tract infection
- History of pelvic radiation therapy
- Presence of spinal deformity
- History of acute low back pain within the past 4-6 weeks
- Receiving pelvic floor muscle training within the past three months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University, Faculty of Medicine, Department of Obstetrics & Gynecology
Izmir
Ayse Kardelen ACAR, MSc, acar.kardelen@gmail.com
Ayse Kardelen ACAR, MSc
About this study
Official title: Comparison of Effects of Dynamic Neuromuscular Stabilization Training and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: A Randomized Controlled Trial
This randomized controlled trial aims to compare the pre- and post-treatment effects of Dynamic Neuromuscular Stabilization (DNS) training and Pelvic Floor Muscle Training (PFMT) on pelvic floor muscle function, pelvic floor morphometry, urinary symptoms, quality of life, sexual function, and physical activity levels in women with stress urinary incontinence (SUI).
Participants diagnosed with SUI by a specialist physician will be randomly assigned to one of three groups: DNS, PFMT, or a control group. Both DNS and PFMT interventions will be delivered as 12-week home exercise programs, performed five days a week and at least three times per day. To support adherence, participants will use an exercise diary. In addition, participants in the DNS and PFMT groups will attend the clinic twice a week for supervised sessions led by a physiotherapist.
The control group will receive a brochure containing lifestyle and bladder health recommendations but will not engage in any structured exercise program.
Read the detailed description
Stress urinary incontinence (SUI) is defined by the International Continence Society as involuntary urine leakage due to insufficient urethral closure pressure during episodes of increased intra-abdominal pressure (IAP), such as coughing, sneezing, laughing, or physical activity. The continence mechanism involves intrinsic urethral closure, structural support of the urethra, and lumbopelvic stability. These components are interconnected through the endopelvic fascia and neural pathways.
The core musculature-including the diaphragm, transversus abdominis (TrA), pelvic floor muscles, and lumbar multifidus-functions synergistically within the myofascial system to regulate IAP. This coordination is essential for maintaining the optimal function of genitourinary organs, especially the bladder.
Dynamic Neuromuscular Stabilization (DNS) targets this integrated spinal stabilization system. DNS exercises are based on developmental kinesiology principles, comparing adult stabilization patterns to those of healthy infants. The goal is to retrain the neuromuscular system through repetitive, functional movements to restore automatic IAP regulation and trunk stability.
Although DNS has demonstrated clinical effectiveness in managing musculoskeletal disorders, cerebral palsy, hemiplegia, and athletic injuries, its role in the management of SUI remains underexplored. By promoting synchronous activation of the deep stabilizers-including the diaphragm, TrA, multifidus, and pelvic floor-DNS may offer a more comprehensive therapeutic approach than isolated pelvic floor muscle training.
In this context, the main questions of this study it aims to answer are:
Does Dynamic Neuromuscular Stabilization (DNS) training have an effect on pelvic floor muscle function, pelvic floor morphometry, symptoms, quality of life, sexual function, and physical activity levels in women with stress urinary incontinence (SUI)? Does Pelvic Floor Muscle Training (PFMT) improve pelvic floor muscle function, pelvic floor morphometry, symptoms, quality of life, sexual function, and physical activity levels in women with stress urinary incontinence (SUI)? Is there a difference between DNS exercises and PFMT in terms of their effects on pelvic floor muscle function, pelvic floor morphometry, symptoms, quality of life, sexual function, and physical activity levels before and after treatment in women with SUI?
- Conditions
- Stress Urinary Incontinence (SUI), Dynamic Neuromuscular Stabilization, Pelvic Floor Muscle Training, Muscle Morphology, Urinary Symptoms, Quality of Life
- Being tested
- Dynamic Neuromuscular Stabilization Training, Pelvic Floor Muscle Training
- Keywords
- stress urinary incontinence, dynamic neuromuscular stabilization, pelvic floor muscle training, physical activity, quality of life, muscle morphology
- Medical subject headings
- Urinary Incontinence, Stress, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Neuromuscular Stabilization TrainingOther
According to the principles of Dynamic Neuromuscular Stabilization (DNS), proper activation of the integrated spinal stabilization system requires that the abdominal muscles expand not only in the caudal direction but also posteriorly and laterally.Therefore, firstly, the physiotherapist will assess the expansion of the entire abdominal wall and teach the patient to regulate intra-abdominal pressure through correct breathing techniques. During training and exercises, a belt will be used. Participants will be instructed to maintain abdominal expansion toward the belt during exercises performed in positions supported by proper alignment. A four-phase exercise protocol based on developmental kinesiology principles will be implemented for the DNS group, beginning with supine-position exercises appropriate for the 3-month developmental stage.
They will be instructed to repeat the exercises at least three times per day.Patients will record their home exercise program using an exercise diary.
Pelvic Floor Muscle TrainingOther
Participants in the PFMT group will undergo a structured pelvic floor muscle training program supervised by a physiotherapist. The training will include verbal and manual instructions to ensure correct identification and isolated activation of the pelvic floor muscles without compensatory movements from the gluteal, abdominal, or thigh muscles using a NeuroTrac Simplex EMG-Biofeedback device.
The exercise protocol will consist of both slow and fast contractions, focusing on endurance, strength, and coordination.
The exercises will be performed in various positions (e.g., supine, sitting, standing) and will gradually progress in intensity and complexity over time, following the principles of motor learning stages. They will be instructed to repeat the exercises at least three times per day. Patients will record their home exercise program using an exercise diary.
| Study group | Role | What they receive |
|---|---|---|
| DNS group | Experimental | Women aged 18-65 who have stress or stress-dominant mixed urinary incontinence. They are followed up for 12 weeks, consisting of 2 days/week face-to-face training sessions with the physiotherapist and 5 days/week sessions conducted by themselves. Receives: Other: Dynamic Neuromuscular Stabilization Training |
| PFMT group | Active comparator | Women aged 18-65 who have stress or stress-dominant mixed urinary incontinence. They are followed up for 12 weeks, consisting of 2 days/week face-to-face training sessions with the physiotherapist and 5 days/week sessions conducted by themselves. Receives: Other: Pelvic Floor Muscle Training |
| Control | No intervention | Receiving patient education only and no exercise was applied to the subjects included in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Hour Pad test
The 1-hour pad test is a standardized objective measurement of urinary leakage under controlled physical activity conditions (e.g., walking, coughing, stair climbing). Participants wear a pre-weighed pad during the test; an increase in weight reflects urine loss. It is used to quantify the severity of stress urinary incontinence (SUI).
Assessment Method: Pad weight difference in grams
Measured: Baseline and 12th week (at the end of the exercise program)
Pelvic Floor Morphometry
3D transperineal ultrasonography allows objective morphometric and functional assessment of all compartments of the pelvic floor. 3D images are taken during rest, maximal voluntary contraction, and Valsalva maneuver, and measurements are recorded for levator ani muscle thickness, levator ani diameter, hiatal area, and the distance between the levator ani, urethra, and symphysis pubis. These measurements will be performed by a urogynecologist.
Measured: Baseline and 12th week (at the end of the exercise program)
Pelvic Floor Muscle Strength and Endurance
The NeuroTract Simplex EMG-Biofeedback device will be used to assess pelvic floor muscle contraction strength (maximum squeeze pressure in cmH₂O or mmHg) and endurance (duration of sustained contraction). This provides an objective measure of muscle performance and training effect.
Measured: Baseline and 12th week (at the end of the exercise program)
Incontinence Quality of Life Questionnaire (I-QOL)
The Incontinence Quality of Life Questionnaire (I-QOL) is a validated self-administered instrument that assesses the impact of urinary incontinence on quality of life a 22 items, including social embarrassment, avoidance behaviors, and psychosocial effects. Higher scores indicate a better perceived quality of life.
A 2.5-point change in the I-QOL scale was determined to be the minimum clinically important difference (MCID) for women with urinary incontinence, representing a threshold at which patients typically report a noticeable improvement in quality of life. A 6.3-point improvement was predicted for the pre- and post-treatment assessment of the same group of women.
Measured: Baseline and 12th week (at the end of the exercise program)
Incontinence Episodes and Number of Pads Used (from 3-Day Bladder Diary)
The number of incontinence episodes and the number of pads used are recorded by participants over three consecutive days. This provides a semi-objective reflection of symptom frequency and the daily impact of SUI.
Assessment Tool: 3-Day Bladder Diary
Measured: Baseline and 12th week (at the end of the exercise program)
Secondary outcomes (5)
24-h Pad Test
A longer-duration objective measurement of urinary leakage. Participants wear a pre-weighed pad for 24 hours during typical daily activities. The post-use weight quantifies real-life incontinence severity.
Assessment Method: Pad weight difference in grams
Measured: Baseline and 12th week (at the end of the exercise program)
Frequency, Nocturia, and Fluid Intake
Additional parameters recorded in the bladder diary include daily voiding frequency, number of nocturnal voids (nocturia), and total fluid intake. These measures reflect bladder behavior and potential treatment-related improvements.
Assessment Tool: 3-Day Bladder Diary
Measured: Baseline and 12th week (at the end of the exercise program)
Pelvic Floor Muscle Strength (Digital Vaginal Palpation - Oxford Scale)
A trained physiotherapist will assess voluntary pelvic floor contractions using the Modified Oxford Scale (0= no contraction; 1= very weak; 2= weak; 3= moderate (with lifting); 4= good (with lifting); 5= strong (with lifting)). This semi-subjective but clinically accepted method provides a rapid evaluation of muscle activation ability.
Assessment Method: Vaginal digital palpation
Measured: Baseline and 12th week (at the end of the exercise program)
Female Sexual Function Index (FSFI)
A 19-item questionnaire evaluating six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. It is widely used in pelvic floor research and helps assess the broader quality-of-life effects of interventions.
Scoring Range: 2-36 (higher scores = better function)
Measured: Baseline and 12th week (at the end of the exercise program)
Physical Activity Levels
A validated questionnaire that quantifies physical activity levels across walking, moderate, and vigorous activities. Results are expressed in MET-minutes per week and allow for analysis of whether interventions affect physical activity engagement. The questionnaire consists of four separate sections and seven questions. It includes questions about the frequency of walking, moderate, and vigorous activities in the past week, and the time spent in these activities. The final question asks about the time spent sitting daily. Higher scores indicate a better outcome. According to the IPAQ scoring protocol, participants are classified into three categories based on total MET-minutes/week: Inactive (<600 MET-minutes/week ), Minimally Active (600-3000 MET-minutes/week ), and Health-Enhancing Physically Active (≥ 3000 MET-minutes/week) Assessment Tool: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Measured: Baseline and 12th week (at the end of the exercise program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start16 Jul 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
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
- Participant
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevtap Günay, Izmir Katip Celebi University
- Investigators
- Ayse Kardelen ACAR, MSc, Principal investigator, Izmir Katıp Celebi University, Institute of Health SciencesSevtap GUNAY UCURUM, Professor, Study director, Izmir Katıp Celebi University, Faculty of Health Sciences, Department of Physiotherapy and RehabilitationAhmet Ozgur YENIEL, Professor, Study chair, Ege University, Faculty of Medicine, Department of Obstetrics & Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075900
- Sponsor's protocol ID
- DYNAPELVIS-SUI2025
- Acronym
- DYNA-SUI
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No