NCT07009249

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 17, 2026

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 21, 2025

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of Pelvic Floor Pre-contraction during valsalva

    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.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (6)

  • Pelvic floor muscle strength (Vaginal palpation)

    From enrollment to the end of treatment at 8 week

  • Resting EMG activity

    From enrollment to the end of treatment at 8 weeks

  • Maximum voluntary contraction

    From enrollment to the end of treatment at 8 weeks

  • Change in Urinary Incontinence Severity

    From enrollment to the end of treatment at 8 weeks

  • Change in urinary symptoms and impact on quality of life

    From enrollment to the end of treatment at 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Pelvic Floor Muscle Training Group (PFMT Group)

ACTIVE COMPARATOR

Women aged 18-62 who have stress or stress-dominant mixed urinary incontinence and can read and write in Turkish

Behavioral: Pelvic floor muscle training

Dynamic Neuromuscular Stabilization Group (DNS Group)

EXPERIMENTAL

Women aged 18-62 who have stress or stress-dominant mixed urinary incontinence and can read and write in Turkish

Behavioral: Dynamic neuromuscular stabilization

Interventions

Women in this group will undergo pelvic floor muscle training (PFMT) using the NeuroTrac MyoPlus 4 PRO EMG biofeedback device. Prior to the training, diaphragmatic breathing will be taught to all participants in this position to facilitate relaxation and prepare for PFMT. During the training, participants will perform pelvic floor muscle contractions while observing the real-time feedback of slow and fast contractions, as well as relaxation phases, on the computer screen connected to the device. Concurrently, the physiotherapist will guide the participants with verbal cues such as "squeeze-lift-release." Participants will be instructed to avoid holding their breath, pulling in their abdomen, straining, contracting the thigh or gluteal muscles, or moving the pelvis during the exercises. The PFMT protocol will follow the principles of motor learning stages to ensure proper skill acquisition.

Pelvic Floor Muscle Training Group (PFMT Group)

Women in this group will be instructed in exercises based on the principles of Dynamic Neuromuscular Stabilization (DNS). Prior to the exercises, intra-abdominal pressure regulation through breathing techniques will be demonstrated. In this study, the Core 360 belt with OhmTrack sensors will be used. Both breathing exercises and DNS exercises will be taught with the belt in place. In a corrected posture, participants will be instructed to gently press the abdominal wall toward the sensors and to maintain expansion of the abdominal wall during both inspiration and expiration, while keeping the spine in a neutral position. The exercise program will begin with a preparatory training phase, which includes fascial mobilizations applied to the feet and hands. DNS exercises will start with the 4.5-month supine developmental position for sagittal stabilization. As the program progresses, exercises will be advanced according to developmental kinesiology positions.

Dynamic Neuromuscular Stabilization Group (DNS Group)

Eligibility Criteria

Age18 Years - 62 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir University of Economics

Izmir, İzmir, 35330, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seda Yakıt Yeşilyurt

    Izmir University of Economics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seda Yakıt Yeşilyurt, Asst. Prof., PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

May 21, 2025

First Posted

June 6, 2025

Study Start

May 21, 2025

Primary Completion

January 1, 2026

Study Completion

May 1, 2026

Last Updated

February 17, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations