Women With Multiple SclerosisNCT07166809
The Effect of DNS-Based Training Combined With PFMT on LUTS and Pelvic Floor Functions in Women With MS
A study testing Pelvic Floor Muscle Training (PFMT) and Pelvic Floor Muscle Training combined with Dynamic Neuromuscular Stabilization (PFMT+DNS) in people with Women With Multiple Sclerosis and Multiple Sclerosis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Women With Multiple Sclerosis, Multiple Sclerosis, Lower Urinary Track Symptoms
- What is being tested?
- Pelvic Floor Muscle Training (PFMT) and Pelvic Floor Muscle Training combined with Dynamic Neuromuscular Stabilization (PFMT+DNS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 27 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis Üniversitesi
Samsun, Samsun, 55270
About this study
Official title: Dynamic Neuromuscular Stabilization Combined With Pelvic Floor Muscle Training Improves Urinary and Pelvic Floor Outcomes in Women With Multiple Sclerosis
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:
Read more
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
- Being tested
- Pelvic Floor Muscle Training (PFMT), Pelvic Floor Muscle Training combined with Dynamic Neuromuscular Stabilization (PFMT+DNS)
- Keywords
- Multiple sclerosis, Lower urinary tract symptoms, Pelvic floor muscle training, stabilization, Dynamic neuromuscular stabilization
- Medical subject headings
- Multiple Sclerosis, Pelvic Floor Disorders, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle Training (PFMT)Other
Also called PFMT
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.
Pelvic Floor Muscle Training combined with Dynamic Neuromuscular Stabilization (PFMT+DNS)Other
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pelvic Floor Muscle Training (PFMT); Other: Pelvic Floor Muscle Training combined with Dynamic Neuromuscular Stabilization (PFMT+DNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: Baseline and 8 weeks
Secondary outcomes (2)
Perceived level of improvement - Global Perceived Effect Scale (GPE)
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."
Measured: Baseline and 8 weeks
Treatment adherence - Visual Analog Scale (VAS)
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."
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Sep 2023
- Primary completion27 Sep 2024
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Seda Kilic, Ondokuz Mayıs University
- Investigators
- SEDA KILIC, DR., Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166809
- Sponsor's protocol ID
- 2022/554
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including questionnaire scores (Urinary Symptom Profile, International Consultation on Incontinence Questionnaire-Short Form, Overactive Bladder Questionnaire), pelvic floor muscle function assessments (PERFECT scheme and electromyography), demographic information (age), and group assignment, will be shared. All data will be anonymized to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Neuromuscular Stabilization Combined With Pelvic Floor Muscle Training Improves Urinary and Pelvic Floor Outcomes in Women With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07166809
- Acronym / sponsor ID
- 2022/554
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PFMT | Active comparator | Other: Pelvic Floor Muscle Training (PFMT)Participants in the PFMT group received only an 8-week remotely monitored pelvic floor muscle training program without additional DNS-based exercises. |
| PFMT+DNS | Experimental | Other: Pelvic Floor Muscle Training (PFMT), Other: Pelvic Floor Muscle Training combined with Dynamic Neuromuscular Stabilization (PFMT+DNS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT)Also: PFMTA 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 | PFMT, PFMT+DNS |
| Pelvic Floor Muscle Training combined with Dynamic Neuromuscular Stabilization (PFMT+DNS)Also: PFMT+DNSParticipants 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 | PFMT+DNS |
Primary outcome
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.
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).
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
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).
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.
2 secondary outcomes
Perceived level of improvement - Global Perceived Effect Scale (GPE)
Time frame: Baseline and 8 weeks
Treatment adherence - Visual Analog Scale (VAS)
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including questionnaire scores (Urinary Symptom Profile, International Consultation on Incontinence Questionnaire-Short Form, Overactive Bladder Questionnaire), pelvic floor muscle function assessments (PERFECT scheme and electromyography), demographic information (age), and group assignment, will be shared. All data will be anonymized to ensure participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEDA KILIC, DR. principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Training (PFMT) and Pelvic Floor Muscle Training combined with Dynamic Neuromuscular Stabilization (PFMT+DNS) in people with Women With Multiple Sclerosis and Multiple Sclerosis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower urinary tract symptoms (LUTS) severity (time frame: Baseline and 8 weeks after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.