Effectiveness of DNS on Incontinence Severity, Pelvic Floor Strength and QoL in Urinary Incontinence

Not Applicable

Not yet recruiting

• Conditions: Urinary Incontinence , Stress; Urinary Incontinence (UI); Exercise
• Interventions: Other: Dynamic Neuromuscular Stabilization Training; Other: Pelvic Floor Muscle Training

• Registration Number: NCT06627452
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

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 52 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.

Detailed Description

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

The research will include young adult women who have been diagnosed with urinary incontinence and volunteered to participate. Participants will be divided into two parallel groups (1:1): the dynamic neuromuscular stabilization (DNS) group and the pelvic floor muscle training (PFMT) group. Our study will be conducted per the Helsinki Declaration, and all participants will be informed about the research and provide written consent.

Indıviduals will be randomly divided into the dynamic neuromuscular stabilization (DNS) and pelvic floor muscle training (PFMT) groups. Randomization will be conducted using the "Research Randomizer" program, and treatment programs will be determined based on this randomization. The treatment program will be implemented by the same experienced physiotherapist, who holds a training certificate in both DNS and PFMT. Participants will be taught how to perform the exercises correctly and receive an exercise sheet containing exercises to perform at home as a guide.

Dynamic Neuromuscular Stabilization Training Participants in this group will undergo Dynamic Neuromuscular Stabilization exercises. The exercises will be performed with the physiotherapist twice a week, while participants will practice at home three days a week, with each session lasting approximately 30 minutes. This program will continue for 12 weeks, totaling five days of exercise per week. The DNS therapist will manually and verbally instruct the participants on how to perform exercises in various developmental positions.

Pelvic Floor Muscle Training Pelvic floor exercises will be taught to patients through vaginal palpation. The exercises will be provided as a home program five days a week. To increase adherence to the home exercises and encourage proper execution, a PTKE schedule and a document demonstrating and explaining the pelvic floor exercises will be provided. Exercise schedules will be checked weekly.

Patients will be instructed to perform pelvic floor exercises in sets for approximately 30 minutes daily over a period of 12 weeks.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-30
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-04-23
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• Diagnosis of mild or moderate severity urinary incontinence based on symptoms
• Being literate
• Aged between 18 and 65
• Not having received any conservative treatment in the last 6 months.

Exclusion Criteria

• Diagnosis of urge incontinence
• 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
• Patients with serious systemic diseases that would prevent them from exercising (such as cardiovascular disease, COPD, stroke, and/or cancer, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Dynamic Neuromuscular Stabilization Training	Participants in Dynamic Neuromuscular Stabilization(DNS) will perform exercises with a physiotherapist twice a week and at home three days a week. The sessions will last approximately 30 minutes and will be conducted five days a week for 12 weeks.
Control Group	Pelvic Floor Muscle Training	Participants in Pelvic Floor Muscle Training (PFMT) will be taught pelvic floor exercises through vaginal palpation. They will perform the exercises with a physiotherapist two days a week and at home three days a week. The sessions will last approximately 30 minutes and will be conducted five days a week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Incontinence Severity Index (ISI)	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Pelvic Floor Muscle Strength (PFMS)	12 WEEKS	Pelvic Floor Muscle Strength (PFMS) will be assessed using a perineometer. The perineometer is a vaginal dynamometer used to objectively and reliably evaluate PFMS. Intravaginal pressure is measured in cmH2O. The vaginal probe is inserted approximately 3.5 cm into the vagina to assess PFMS. The patient is instructed to squeeze the probe. During the measurement, patients are asked to contract their pelvic floor muscles as strongly as possible without any visible co-contraction of the hip adductor, gluteal, or abdominal muscles. They should maintain this contraction for 10 seconds and then relax without pushing the perineum downward at the end of the contraction. Pelvic floor muscle strength is calculated by subtracting the resting value from the maximum value achieved during the contraction.
Quality of Life Assessment	12 WEEKS	The King Health Questionnaire (KHQ) will evaluate the patient\'s quality of life. The KHQ is a commonly used survey comprising 32 items divided into two sections. It is designed to assess patients\' quality of life with urinary incontinence. In addition to two single-item questions regarding general health status and quality of life impact, it includes seven subheadings made up of multiple items: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep, and energy disturbances related to urinary incontinence, and severity measurements for urinary incontinence. The second section is the 11-item Symptom Severity Scale, which evaluates the presence and severity of urinary symptoms. The score for the Symptom Severity Scale ranges from 0 (best) to 30 (worst). Scores for other KHQ areas range from 0 (best) to 100 (worst). A higher score indicates a deterioration in the patient\'s quality of life.

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa; 🇹🇷 Istanbul, Turkey