Comparison of Effects of Dynamic Neuromuscular Stabilization Training and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- 1-Hour Pad test
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
1-Hour Pad test
时间窗: Baseline and 12th week (at the end of the exercise program)
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
Pelvic Floor Morphometry
时间窗: Baseline and 12th week (at the end of the exercise program)
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.
Pelvic Floor Muscle Strength and Endurance
时间窗: Baseline and 12th week (at the end of the exercise program)
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.
Incontinence Quality of Life Questionnaire (I-QOL)
时间窗: Baseline and 12th week (at the end of the exercise program)
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.
Incontinence Episodes and Number of Pads Used (from 3-Day Bladder Diary)
时间窗: Baseline and 12th week (at the end of the exercise program)
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
次要结局
- 24-h Pad Test(Baseline and 12th week (at the end of the exercise program))
- Frequency, Nocturia, and Fluid Intake(Baseline and 12th week (at the end of the exercise program))
- Pelvic Floor Muscle Strength (Digital Vaginal Palpation - Oxford Scale)(Baseline and 12th week (at the end of the exercise program))
- 24-h Pad Test(Baseline and 12th week (at the end of the exercise program))
- Frequency, Nocturia, and Fluid Intake(Baseline and 12th week (at the end of the exercise program))
- Pelvic Floor Muscle Strength (Digital Vaginal Palpation - Oxford Scale)(Baseline and 12th week (at the end of the exercise program))
- Female Sexual Function Index (FSFI)(Baseline and 12th week (at the end of the exercise program))
- Physical Activity Levels(Baseline and 12th week (at the end of the exercise program))
研究者
Sevtap Günay
Associate Professor
Izmir Katip Celebi University