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

NCT07166809 | Completed

• 1 other identifier: 2022/554
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

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

Keywords

Multiple sclerosis; Lower urinary tract symptoms; Pelvic floor muscle training; stabilization; Dynamic neuromuscular stabilization

Outcome Measures

Primary Outcomes (5)

• Lower urinary tract symptoms (LUTS) severity

  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.

  Baseline and 8 weeks after intervention

• Urinary incontinence severity and impact on quality of life

  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).

  baseline and 8 weeks

• Overactive bladder symptoms

  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

  Baseline and 8 weeks

• Pelvic Floor Muscle Function - Vaginal Palpation

  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).

  Baseline and 8 weeks

• Pelvic floor muscle function - Electromyography (EMG)

  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.

  Baseline and 8 weeks

Secondary Outcomes (2)

• Perceived level of improvement - Global Perceived Effect Scale (GPE)

  Baseline and 8 weeks

• Treatment adherence - Visual Analog Scale (VAS)

  Baseline and 8 weeks

Study Arms (2)

PFMT

ACTIVE COMPARATOR

Participants in the PFMT group received only an 8-week remotely monitored pelvic floor muscle training program without additional DNS-based exercises.

Other: Pelvic Floor Muscle Training (PFMT)

PFMT+DNS

EXPERIMENTAL

Participants in the PFMT+DNS group received the same 8-week remotely monitored pelvic floor muscle training program, in addition to supervised Dynamic Neuromuscular Stabilization exercises three times per week.

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

Interventions

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.

Also known as: PFMT

PFMT; PFMT+DNS

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.

Also known as: PFMT+DNS

PFMT+DNS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female participants who self-identify as women are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ondokuz Mayis Üniversitesi

Samsun, Samsun, 55270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Pelvic Floor Disorders; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• SEDA KILIC, DR.

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

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: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 10, 2025
• Study Start: September 1, 2023
• Primary Completion: September 27, 2024
• Study Completion: August 27, 2025
• Last Updated: May 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Available 12 months after publication of the main study results
• Access Criteria: De-identified individual participant data and supporting documents (Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code) will be available to qualified researchers for academic and scientific purposes. Researchers must submit a request to the Principal Investigator with a brief research proposal. Access will be granted after approval and signing a data use agreement. Data will be shared through a secure repository to ensure confidentiality.

Locations

TU (1)