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Completed

NCT Number: NCT07166809

The Effect of DNS-Based Training Combined With PFMT on LUTS and Pelvic Floor Functions in Women With MS

The goal of this randomized controlled trial is to investigate whether adding Dynamic Neuromuscular Stabilization (DNS)-based training to Pelvic Floor Muscle Training (PFMT) can improve lower urinary tract symptoms (LUTS) and pelvic floor functions in women with multiple sclerosis (MS), aged 28-54 years.

The main questions it aims to answer are:

Does DNS combined with PFMT improve lower urinary tract symptoms more effectively than PFMT alone?

Does DNS combined with PFMT enhance pelvic floor muscle function more effectively than PFMT alone?

Researchers will compare PFMT alone versus PFMT combined with DNS-based stabilization exercises to see if DNS provides additional benefits.

Participants will:

Perform an 8-week remotely monitored Pelvic Floor Muscle Training program.

In the DNS+PFMT group, complete supervised Dynamic Neuromuscular Stabilization exercises three times a week.

Undergo assessments including:

Urinary Symptom Profile questionnaire,

International Consultation on Incontinence Questionnaire-Short Form,

Overactive Bladder Questionnaire (8-item version),

Vaginal palpation using the PERFECT (Power, Endurance, Repetitions, Fast contractions, Every Contraction Timed) scheme,

Electromyography (muscle electrical activity measurement) for pelvic floor muscles evaluation.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-65 years
  • Diagnosis of multiple sclerosis with an Expanded Disability Status Scale (EDSS) score below 6
  • Pelvic floor muscle strength greater than grade 1 according to the Modified Oxford Scale (MOS)
  • No pelvic floor muscle training received in the previous six months

Exclusion criteria

  • Multiple sclerosis relapse within the past month
  • Pregnant or within six months postpartum
  • Diagnosis of urinary tract infection
  • Any medical condition that could interfere with participation

Treatment and study plan

pelvic floor muscle training (PFMT)

Other

A structured pelvic floor muscle training program delivered remotely for 8 weeks, including exercises designed to strengthen and improve the endurance, coordination, and control of the pelvic floor muscles.

Other names: PFMT

Pelvic Floor Muscle Training combined with Dynamic Neuromuscular Stabilization (PFMT+DNS)

Other

Participants received the same 8-week remotely monitored pelvic floor muscle training program as the PFMT group, in addition to supervised Dynamic Neuromuscular Stabilization exercises three times per week. DNS exercises aimed to enhance core stability, postural control, and coordination to support pelvic floor muscle function.

Other names: PFMT+DNS

Primary outcomes

  1. Lower urinary tract symptoms (LUTS) severity

    Time frame: Baseline and 8 weeks after intervention

    Lower urinary tract symptoms (LUTS) severity measured by the Urinary Symptom Profile (USP) questionnaire. The USP includes three subdomains: stress urinary incontinence (0-9), overactive bladder symptoms (0-21), and voiding symptoms (0-9) with total scores ranging from 0 to 39, higher scores indicating greater severity.

  2. Urinary incontinence severity and impact on quality of life

    Time frame: baseline and 8 weeks

    Urinary incontinence severity and impact on quality of life assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The ICIQ-SF assesses urinary leakage frequency, volume, and daily life impact, scored 0-21, with ≥8 indicating clinically significant incontinence (Cronbach's α = 0.71).

  3. Overactive bladder symptoms

    Time frame: Baseline and 8 weeks

    Overactive bladder symptoms measured by the Overactive Bladder-Version 8 (OAB-V8). The OAB-V8 comprises eight 5-point items (total 0-40), with higher scores reflecting greater bother, and a cutoff of 11 indicating clinically relevant overactive bladder symptoms

  4. Pelvic Floor Muscle Function - Vaginal Palpation

    Time frame: Baseline and 8 weeks

    Pelvic floor muscle function was assessed by digital vaginal palpation using the PERFECT scheme. The examiner inserted one or two gloved fingers into the vagina and instructed the participant to contract and relax the pelvic floor muscles. Parameters recorded included: Power (maximum voluntary contraction, graded on the Modified Oxford Scale), Endurance (duration of sustained contraction in seconds), Repetitions (number of sustained contractions), Fast contractions (number of quick contractions), and Every Contraction Timed (consistency of contraction timing).

  5. Pelvic floor muscle function - Electromyography (EMG)

    Time frame: Baseline and 8 weeks

    EMG biofeedback device was used to measure the bioelectrical activity of the pelvic floor muscles. EMG provides an objective evaluation of muscle contraction and relaxation. Intravaginal probes were used as they are considered the gold standard (17). Assessments were performed using the Neurotrac MyoPlus Pro (Verity Medical Ltd.), which recorded parameters such as muscle strength, endurance, relaxation ability, and resting tone. During the EMG evaluation, participants were positioned supine in lithotomy, and a personalized intravaginal probe was inserted by the clinician. After ensuring the participant understood how to correctly contract the pelvic floor muscles, the EMG protocol included a warm-up phase with five contractions and five relaxations, followed by three cycles of 5-second contraction and 5-second relaxation periods.

Secondary outcomes

  1. Perceived level of improvement - Global Perceived Effect Scale (GPE)

    Time frame: Baseline and 8 weeks

    The Global Perceived Effect Scale (GPE) was used to assess participants' perceived level of improvement following the intervention. This validated questionnaire categorizes perceived recovery into nine levels, ranging from (1) "very much improved" to (9) "very much worse," with intermediate options such as "moderately improved" or "unchanged."

  2. Treatment adherence - Visual Analog Scale (VAS)

    Time frame: Baseline and 8 weeks

    Treatment adherence was evaluated using a Visual Analog Scale (VAS). Participants rated their adherence to the treatment program on a scale from 0 to 10, where 0 indicated "not adherent at all" and 10 indicated "completely adherent."

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Dynamic Neuromuscular Stabilization Combined With Pelvic Floor Muscle Training Improves Urinary and Pelvic Floor Outcomes in Women With Multiple Sclerosis

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 10, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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