Women With Multiple Sclerosis, Multiple Sclerosis, Lower Urinary Track Symptoms, Pelvic Floor Disorder
Conditions
Keywords
Multiple sclerosis, Lower urinary tract symptoms, Pelvic floor muscle training, stabilization, Dynamic neuromuscular stabilization
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.
Interventions
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.
OTHERPelvic Floor Muscle Training combined with Dynamic Neuromuscular Stabilization (PFMT+DNS)
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.
Sponsors
The Scientific and Technological Research Council of Turkey
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants were randomly assigned to one of two parallel groups: pelvic floor muscle training (PFMT) only or PFMT combined with Dynamic Neuromuscular Stabilization (DNS). Both groups followed an 8-week program, with the intervention group receiving additional supervised DNS exercises.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed