Dynamic Neuromuscular Stabilization Exercises in Women With Urinary Incontinence

Not Applicable

Recruiting

• Conditions: Stress Urinary Incontinence (SUI); Dynamic Neuromuscular Stabilization; Pelvic Floor Muscle Training; Urinary Symptoms; Biofeedback Training

• Registration Number: NCT07009249
• Lead Sponsor: Izmir University of Economics

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-21
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2025-12-30
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• 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.

Exclusion Criteria

• 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),
• Active lower urinary tract infection,
• Presence of respiratory disorders such as chronic obstructive pulmonary disease or asthma,
• History of hysterectomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of Pelvic Floor Pre-contraction during valsalva	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.

Secondary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength (Vaginal palpation)	From enrollment to the end of treatment at 8 week	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))
Resting EMG activity	From enrollment to the end of treatment at 8 weeks	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).
Maximum voluntary contraction	From enrollment to the end of treatment at 8 weeks	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.
Change in Urinary Incontinence Severity	From enrollment to the end of treatment at 8 weeks	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.
Change in urinary symptoms and impact on quality of life	From enrollment to the end of treatment at 8 weeks	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.
Change of contraction onset time	From enrollment to the end of treatment at 8 weeks	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.

Trial Locations

Locations (1)

Izmir University of Economics; 🇹🇷 İzmir, Turkey