Clinical trial NCT07009249: Dynamic Neuromuscular Stabilization Exercises in Women With Urinary Incontinence
Official title: Effects of Dynamic Neuromuscular Stabilization Exercises on Urinary Symptoms and Pelvic Floor Muscle Functions in Women With Stress Urinary Incontinence: A Single-Blind Non-Inferiority Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence (SUI)
Dynamic Neuromuscular Stabilization
Pelvic Floor Muscle Training
Urinary Symptoms
Biofeedback Training
Lead sponsor: Izmir University of Economics
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of Pelvic Floor Pre-contraction during valsalva
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Pelvic floor muscle strength (Vaginal palpation)
timeFrame: From enrollment to the end of treatment at 8 week
measure: Resting EMG activity
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Maximum voluntary contraction
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change in Urinary Incontinence Severity
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change in urinary symptoms and impact on quality of life
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change of contraction onset time
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir University of Economics
Study officials:
affiliation: Izmir University of Economics
name: Seda Yakıt Yeşilyurt
role: PRINCIPAL_INVESTIGATOR
References: