Ondokuz Mayis Üniversitesi
Samsun, 55270, Turkey (Türkiye)
NCT Number: NCT07166809
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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Notify Me18 year–65 year
Female
Interventional
Not applicable
Samsun, 55270, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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).
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
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).
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.
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."
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."
Ondokuz Mayıs University
Other
Dynamic Neuromuscular Stabilization Combined With Pelvic Floor Muscle Training Improves Urinary and Pelvic Floor Outcomes in Women With Multiple Sclerosis
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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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