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

Not Applicable

Completed

• Conditions: Women With Multiple Sclerosis; Multiple Sclerosis; Lower Urinary Track Symptoms; Pelvic Floor Disorder

• Registration Number: NCT07166809
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

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 and uroflowmetry for objective evaluation of lower urinary tract symptoms,

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,

Magnetic Resonance Imaging (MRI) for diaphragm function evaluation.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-09-27
• Study Completion: 2025-08-27
• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lower urinary tract symptoms (LUTS) severity	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.
Urinary incontinence severity and impact on quality of life	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).
Overactive bladder symptoms	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
Objective urinary flow parameters	Baseline and 8 weeks	Objective urinary flow parameters assessed by uroflowmetry. Uroflowmetry, a non-invasive diagnostic test, was performed. Participants were instructed to void naturally into a uroflowmeter device in a private setting. The device automatically recorded maximum bladder capacity (mL), maximum flow rate (Qmax, mL/s), average flow rate (Qavg, mL/s), and voided volume (mL).
Pelvic Floor Muscle Function - Vaginal Palpation	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).
Pelvic floor muscle function - Electromyography (EMG)	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 Outcome Measures

Name	Time	Method
Diaphragm Function - Magnetic Resonance Imaging (MRI)	Baseline and 8 weeks	Diaphragm function was assessed using Magnetic Resonance Imaging (MRI). Dynamic MRI sequences were performed during inspiration and expiration to evaluate diaphragm mobility and muscle activity. Measurements included excursion (movement in millimeters) and changes in diaphragm thickness as indicators of contractile function.
Perceived level of improvement - Global Perceived Effect Scale (GPE)	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."
Treatment adherence - Visual Analog Scale (VAS)	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."

Trial Locations

Locations (1)

Ondokuz Mayis Üniversitesi; Samsun, Samsun, Turkey (Türkiye)