The Effectiveness of Dynamic Neuromuscular Stabilization on Incontinence Severity, Pelvic Floor Muscle Strength and Quality of Life in Women With Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Incontinence Severity Index (ISI)
研究概览
简要总结
The aim of this study is to investigate the effects of Dynamic Neuromuscular Stabilization (DNS) Training on incontinence severity, pelvic floor muscle strength, and quality of life in women with Urinary Incontinence, compared to Pelvic Floor Muscle Training (PFMT). The hypothesis of the study is that DNS Training will be at least as effective as PFMT in terms of its impact on incontinence severity, pelvic floor muscle strength, and quality of life in women with Urinary Incontinence. A total of 56 women diagnosed with urinary incontinence will be included in the study. Participants will be divided into two groups: DNS and PFMT, and will engage in the designated exercise program 5 days a week for a total of 12 weeks. All participants will undergo an initial assessment before starting treatment, and a final assessment will be conducted by the same physiotherapist after the treatment.
详细描述
Urinary incontinence (UI) is defined by the International Continence Society as involuntary leakage of urine and is a symptom that can objectively be demonstrated, leading to social and hygienic problems. UI negatively affects daily life activities, perception of health status, and mental and social well-being, thereby reducing individuals; health-related quality of life. UI is commonly observed in women, with a reported prevalence ranging from 25% to 45%. There are three main types of urinary incontinence: stress urinary incontinence, urge urinary incontinence, and mixed urinary incontinence. The most commonly seen type, stress urinary incontinence, is defined as involuntary urine leakage due to a sudden increase in intra-abdominal pressure (IAP) during activities such as coughing, sneezing, exertion, or physical activity without detrusor contraction. It generally occurs after childbirth or during pregnancy. Risk factors for stress urinary incontinence in women include a higher number of births, age, smoking, lung disease, and obesity. One of the significant causes of UI is the weakness of the pelvic floor muscles (PFM).
It is known that the PFM helps stabilize the bladder neck and contributes to continence control by increasing intraurethral pressure. The PFM also aids in stabilizing the lumbopelvic region (core). Studies show that the transverse abdominis (TrA), one of the most essential muscles providing core stabilization, works synergistically with the PFM. This co-activation has been reported to enhance pelvic stability and support urinary control, modulating IAP and load transfer. In this context, in addition to PFM training, stabilization exercises have begun to be included in treatment programs for patients with UI as a first-line treatment.
Dynamic Neuromuscular Stabilization (DNS) is a neuromuscular and functional stabilization approach based on developmental kinesiology models, utilizing the normal motor development process to assess and treat motor disorders. The primary aim is to restore the physiological movement patterns defined by developmental kinesiology. DNS provides stabilization of the spine and surrounding muscles during static and dynamic movements. Deep spinal flexors and extensors, multifidus, diaphragm, pelvic floor muscles, and abdominal muscles are part of this system. The co-contractions of these muscles increase IAP, thereby aiding. This also helps with stabilization. DNS is based on the principle that the core muscle system works synergistically with various components. When part of this system is weak or dysfunctional, it can also affect the functioning of other core muscles. DNS exercises focus on comprehensive activation and strengthening of the entire core muscle system rather than targeting individual muscles one by one. In this context, DNS training includes the development of pelvic floor muscles along with the improvement of core (lumbopelvic) stabilization.
It is known that the strength of the pelvic floor muscles (PFM) decreases in women with UI, and strengthening these muscles plays a crucial role in controlling incontinence. However, there are also studies reporting low stabilization in women with UI. Considering that stress urinary incontinence occurs due to a sudden increase in intra-abdominal pressure during physical activity, regulating IAP and improving stabilization could be more effective in controlling UI. The DNS method, which targets lumbopelvic stabilization along with PFM training and focuses on intra-abdominal pressure regulation, has been shown to have positive effects on various neuromuscular disorders and postural dysfunctions. There is only one pilot study in the literature investigating the effects of DNS training on women with UI. This study reported that DNS improved PFM strength more than Kegel exercises. Given this information, it is hypothesized that DNS training may more effectively reduce the severity of urinary incontinence in women compared to PFM training. Therefore, this research aims to compare the effects of DNS training on urinary incontinence severity in women with urinary incontinence to PFM training.
METHOD
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
- Double (Participant, Outcomes Assessor)
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
- •Diagnosis of severity stress urinary incontinence based on symptoms
- •Being literate
- •Aged between 18 and 65
- •Not having received any conservative treatment in the last 6 months.
排除标准
- •Presence of prolapse
- •Diagnosis of overactive bladder
- •Ongoing urinary tract infection
- •Use of medication for urinary incontinence
- •Pregnancy
- •Lack of cooperation for assessment and/or treatment
- •Having undergone uro-surgical procedures within the last two years
- •Patients with serious systemic diseases that would prevent them from exercising (such as cardiovascular disease, COPD, stroke, and/or cancer, etc.)
结局指标
主要结局
Incontinence Severity Index (ISI)
时间窗: 12 WEEKS
Patients incontinence severity will be assessed using the Incontinence Severity Index (ISI). The index has two questions: 1) How often do you leak urine? (0=Never, 1=Less than once a month, 2=Once a month, 3=Several times a week, 4=Almost every day/night), and 2) How much urine do you leak? (0=None, 1=A few drops, 2=Small spots, 3=More). The result obtained from this index is the product of the two items that assess the frequency and amount of incontinence. The total score ranges from 1 to 12 and is categorized into four levels of incontinence severity: Mild (1 and 2 points), Moderate (3, 4, and 6 points), severe (8 and 9 points), and very severe (12 points).
24-Hour Pad Test
时间窗: 12 WEEKS
The pad test is one of the assessments that provide information about the severity of incontinence. One day before the examination, patients will be instructed to place a dry pad in their underwear after their first morning urination and continue their daily activities. They should change the pad every 4 to 6 hours to prevent evaporation and store the used pads in a sealed bag. Patients must bring all pads used until the next morning, along with a dry pad sample, for examination. The pads will be weighed on a sensitive scale to calculate the amount of urinary leakage. In the 24-hour pad test, values above 4 grams are considered significant, with incontinence severity classified as mild (≥4-20 grams/24 hours), moderate (21-74 grams/24 hours), and severe (≥75 grams/24 hours).
Urinary Diary
时间窗: 12 WEEKS
A urinary diary is an assessment tool that records the frequency of urination, types and amounts of fluids consumed, and the frequency and severity of incontinence over a specified period. The recommended duration for keeping the diary is typically 1 to 7 days. A 3-day diary has been noted as an appropriate outcome measure for clinical studies evaluating stress incontinence treatments. Patients are advised not to change their usual urination habits or fluid intake while completing the diaries. A total of three diaries are collected from each patient and filled out on non-consecutive days. Patients are asked to record their urination times, the amount of urine produced, and their activities at the time of any leakage, including the corresponding times.
次要结局
- Pelvic Floor Muscle Strength (PFMS)(12 WEEKS)
- Quality of Life Assessment(12 WEEKS)
- Pelvic Floor Muscle Strength (PFMS)(12 WEEKS)
- Quality of Life Assessment(12 WEEKS)
研究者
Ayse Zengin Alpozgen
Assoc. Prof.
Istanbul University - Cerrahpasa