Dynamic Neuromuscular Stabilization vs Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence

NCT07075900 | Recruiting

• 1 other identifier: DYNAPELVIS-SUI2025
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare the pre- and post-treatment effects of Dynamic Neuromuscular Stabilization (DNS) training and Pelvic Floor Muscle Training (PFMT) on pelvic floor muscle function, pelvic floor morphometry, urinary symptoms, quality of life, sexual function, and physical activity levels in women with stress urinary incontinence (SUI). Participants diagnosed with SUI by a specialist physician will be randomly assigned to one of three groups: DNS, PFMT, or a control group. Both DNS and PFMT interventions will be delivered as 12-week home exercise programs, performed five days a week and at least three times per day. To support adherence, participants will use an exercise diary. In addition, participants in the DNS and PFMT groups will attend the clinic twice a week for supervised sessions led by a physiotherapist. The control group will receive a brochure containing lifestyle and bladder health recommendations but will not engage in any structured exercise program.

Conditions

Stress Urinary Incontinence (SUI); Muscle Morphology; Dynamic Neuromuscular Stabilization; Pelvic Floor Muscle Training; Urinary Symptoms; Quality of Life

Keywords

stress urinary incontinence; dynamic neuromuscular stabilization; pelvic floor muscle training; physical activity; quality of life; muscle morphology

Outcome Measures

Primary Outcomes (5)

• 1-Hour Pad test

  The 1-hour pad test is a standardized objective measurement of urinary leakage under controlled physical activity conditions (e.g., walking, coughing, stair climbing). Participants wear a pre-weighed pad during the test; an increase in weight reflects urine loss. It is used to quantify the severity of stress urinary incontinence (SUI). Assessment Method: Pad weight difference in grams

  Baseline and 12th week (at the end of the exercise program)

• Pelvic Floor Morphometry

  3D transperineal ultrasonography allows objective morphometric and functional assessment of all compartments of the pelvic floor. 3D images are taken during rest, maximal voluntary contraction, and Valsalva maneuver, and measurements are recorded for levator ani muscle thickness, levator ani diameter, hiatal area, and the distance between the levator ani, urethra, and symphysis pubis. These measurements will be performed by a urogynecologist.

  Baseline and 12th week (at the end of the exercise program)

• Pelvic Floor Muscle Strength and Endurance

  The NeuroTract Simplex EMG-Biofeedback device will be used to assess pelvic floor muscle contraction strength (maximum squeeze pressure in cmH₂O or mmHg) and endurance (duration of sustained contraction). This provides an objective measure of muscle performance and training effect.

  Baseline and 12th week (at the end of the exercise program)

• Incontinence Quality of Life Questionnaire (I-QOL)

  The Incontinence Quality of Life Questionnaire (I-QOL) is a validated self-administered instrument that assesses the impact of urinary incontinence on quality of life a 22 items, including social embarrassment, avoidance behaviors, and psychosocial effects. Higher scores indicate a better perceived quality of life. A 2.5-point change in the I-QOL scale was determined to be the minimum clinically important difference (MCID) for women with urinary incontinence, representing a threshold at which patients typically report a noticeable improvement in quality of life. A 6.3-point improvement was predicted for the pre- and post-treatment assessment of the same group of women.

  Baseline and 12th week (at the end of the exercise program)

• Incontinence Episodes and Number of Pads Used (from 3-Day Bladder Diary)

  The number of incontinence episodes and the number of pads used are recorded by participants over three consecutive days. This provides a semi-objective reflection of symptom frequency and the daily impact of SUI. Assessment Tool: 3-Day Bladder Diary

  Baseline and 12th week (at the end of the exercise program)

Secondary Outcomes (5)

• 24-h Pad Test

  Baseline and 12th week (at the end of the exercise program)

• Frequency, Nocturia, and Fluid Intake

  Baseline and 12th week (at the end of the exercise program)

• Pelvic Floor Muscle Strength (Digital Vaginal Palpation - Oxford Scale)

  Baseline and 12th week (at the end of the exercise program)

• Female Sexual Function Index (FSFI)

  Baseline and 12th week (at the end of the exercise program)

• Physical Activity Levels

  Baseline and 12th week (at the end of the exercise program)

Study Arms (3)

DNS group

EXPERIMENTAL

Women aged 18-65 who have stress or stress-dominant mixed urinary incontinence. They are followed up for 12 weeks, consisting of 2 days/week face-to-face training sessions with the physiotherapist and 5 days/week sessions conducted by themselves.

Other: Dynamic Neuromuscular Stabilization Training

PFMT group

ACTIVE COMPARATOR

Women aged 18-65 who have stress or stress-dominant mixed urinary incontinence. They are followed up for 12 weeks, consisting of 2 days/week face-to-face training sessions with the physiotherapist and 5 days/week sessions conducted by themselves.

Other: Pelvic Floor Muscle Training

Control

NO INTERVENTION

Receiving patient education only and no exercise was applied to the subjects included in the control group.

Interventions

Pelvic Floor Muscle Training OTHER

Participants in the PFMT group will undergo a structured pelvic floor muscle training program supervised by a physiotherapist. The training will include verbal and manual instructions to ensure correct identification and isolated activation of the pelvic floor muscles without compensatory movements from the gluteal, abdominal, or thigh muscles using a NeuroTrac Simplex EMG-Biofeedback device. The exercise protocol will consist of both slow and fast contractions, focusing on endurance, strength, and coordination. The exercises will be performed in various positions (e.g., supine, sitting, standing) and will gradually progress in intensity and complexity over time, following the principles of motor learning stages. They will be instructed to repeat the exercises at least three times per day. Patients will record their home exercise program using an exercise diary.

PFMT group

Dynamic Neuromuscular Stabilization Training OTHER

According to the principles of Dynamic Neuromuscular Stabilization (DNS), proper activation of the integrated spinal stabilization system requires that the abdominal muscles expand not only in the caudal direction but also posteriorly and laterally.Therefore, firstly, the physiotherapist will assess the expansion of the entire abdominal wall and teach the patient to regulate intra-abdominal pressure through correct breathing techniques. During training and exercises, a belt will be used. Participants will be instructed to maintain abdominal expansion toward the belt during exercises performed in positions supported by proper alignment. A four-phase exercise protocol based on developmental kinesiology principles will be implemented for the DNS group, beginning with supine-position exercises appropriate for the 3-month developmental stage. They will be instructed to repeat the exercises at least three times per day.Patients will record their home exercise program using an exercise diary.

DNS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged between 18 and 65 years
• Diagnosed with stress urinary incontinence or stress-dominant mixed urinary incontinence by a specialist physician
• Having the ability to voluntarily contract the pelvic floor muscles
• Literate in Turkish
• Willing and voluntarily consenting to participate in the study

You may not qualify if:

• Pregnancy
• Presence of urgency-predominant urinary incontinence symptoms or fecal incontinence
• Inability to understand or cooperate with assessment procedures
• Presence of any neurological or rheumatological disease
• Severe cardiac or pulmonary disease
• Uncontrolled diabetes mellitus or hypertension
• Chronic liver and/or kidney failure
• Advanced pelvic organ prolapse (greater than grade 2)
• History of abdominal or pelvic surgery (including cesarean section) within the past year
• History of spinal surgery
• Current urinary tract infection
• History of pelvic radiation therapy
• Presence of spinal deformity
• History of acute low back pain within the past 4-6 weeks
• Receiving pelvic floor muscle training within the past three months

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Ege University, Faculty of Medicine, Department of Obstetrics & Gynecology

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Motor Activity

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Ayse Kardelen ACAR, MSc

  Izmir Katıp Celebi University, Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

• Sevtap GUNAY UCURUM, Professor

  Izmir Katıp Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

  STUDY DIRECTOR

• Ahmet Ozgur YENIEL, Professor

  Ege University, Faculty of Medicine, Department of Obstetrics & Gynecology

  STUDY CHAIR

Central Study Contacts

Sevtap GUNAY UCURUM, Professor

CONTACT

+90 232 3293535/4717; sevtapgunay.tfd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)