Multiple SclerosisNCT06805331
The Effect of Health Belief Model-Based Pelvic Floor Muscle Exercise Training on Urinary Incontinence and Quality of Life in Female Patients With Multiple Sclerosis
A study testing Intervention group(Pelvic Floor Muscle Exercise Training) in people with Multiple Sclerosis and Urinary Incontinence, run by Nurgül KAPLAN at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of Pelvic Floor Muscle Exercise Training According to the Health Belief Model on Urinary Incontinence and Quality of Life in Female Patients with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis, Urinary Incontinence
- What is being tested?
- Intervention group(Pelvic Floor Muscle Exercise Training)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 31 Dec 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years old and above,
- Being a woman,
- Being diagnosed with MS,
- Having urinary incontinence,
- Not having an attack in the last thirty days,
- No change in medical treatment in the last three months,
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- Being under 6.5 on the Expanded Disability Status Scale (EDSS),
- Not having a diagnosis of cognitive or mental disorder,
- Being willing to participate in the study,
Who cannot join
- Presence of pregnancy,
- Presence of urinary tract infection,
- Presence of another neurological disease that may cause incontinence,
- History of cancer,
- History of pelvic surgery,
- Presence of pelvic organ prolapse,
Show all 10Show fewer
- Deficiency in evaluation parameters,
- Non-compliance with treatment programs,
- Change in drug treatment during treatment,
- Receiving PTCE in the last six months
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effect of Pelvic Floor Muscle Exercise Training According to the Health Belief Model on Urinary Incontinence and Quality of Life in Female Patients with Multiple Sclerosis.
Hypothesis 01: Pelvic floor muscle exercise training applied using the health belief model is not effective in reducing urinary complaints in female MS patients.
Read more
Hypothesis 1: Pelvic floor muscle exercise training applied using the health belief model is effective in reducing urinary complaints in female MS patients.
Hypothesis 02: Pelvic floor muscle exercise training applied using the health belief model is not effective on the quality of life of female MS patients.
Hypothesis 2: Pelvic floor muscle exercise training applied using the health belief model is effective on the quality of life of female MS patients.
Read the detailed description
This study will be conducted to evaluate the effect of pelvic floor muscle exercise (PFMT) training on urinary incontinence and quality of life in women with multiple sclerosis (MS) according to the health belief model (HBM). This study will be conducted as a randomized controlled experimental study with 46 women with urinary incontinence complaints who were diagnosed with MS and followed up at the MS outpatient clinic of the Neurology Department of Tokat Gaziosmanpaşa University Hospital. Patients will be included in the control (23) and intervention (23) groups by simple randomization method. In collecting the research data; Questionnaire on Descriptive Characteristics, International Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Quality of Life Scale (I-QOL), Incontinence Severity Index (ISI), Broome Pelvic Floor Muscle Exercise Self-Efficacy Scale (Broome PMSES), Expanded Disability Status Scale (EDSS), Bladder diary will be used. The research data will be collected after the experimental and control groups are determined after the approval. Data collection forms will be applied to both groups at the beginning of the study and at the end of the 1st and 3rd months. Patients in the intervention group will perform pelvic floor muscle exercises 3 times a day (morning-afternoon-evening) for 3 months. No intervention will be applied to patients in the control group. The data will be entered into a statistical package program and evaluated. No study has been found in the literature evaluating the effect of PTCE training according to the SIM on urinary incontinence and quality of life in female patients with MS. The research has original value in this respect and will contribute scientifically to national and international literature. If the research is successful, it is thought that PTCE training according to the health belief model in female patients with MS will be proven as a non-pharmacological intervention and will provide a new nursing intervention in the field. PTCE training according to the SIM in female patients with MS will reduce urinary incontinence and increase quality of life. In addition, it is thought that it will contribute positively to the physiological, psychological and social recovery process of MS patients.
- Conditions
- Multiple Sclerosis, Urinary Incontinence
- Being tested
- Intervention group(Pelvic Floor Muscle Exercise Training), control group
- Keywords
- Exercise training, Multiple Sclerosis, Pelvic Floor Muscle Exercise, Health Belief Model, Urinary Incontinence, Quality of Life
- Medical subject headings
- Multiple Sclerosis, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group(Pelvic Floor Muscle Exercise Training)Behavioural
The intervention will involve educating participants on pelvic floor muscle exercises, using the health belief model. The goal is to evaluate improvements in incontinence severity, quality of life, and pelvic floor muscle exercise self-efficacy
control groupOther
Participants in the control group will continue to receive their current standard of care and will not receive any additional interventions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Pelvic Floor Muscle Exercise Training) | Experimental | The researcher will explain pelvic floor muscle exercises to the patients within the framework of the health belief model. After the pelvic floor muscle exercise training is given, the patients will be asked to do these exercises three times a day (morning-afternoon-evening) for three months (12 weeks). Receives: Behavioral: Intervention group(Pelvic Floor Muscle Exercise Training) |
| No Intervention (Control Group) | Other | Participants in the control group will undergo standard care procedures without receiving any intervention. The results will be evaluated for comparison purposes. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Incontinence
Urinary incontinence severity and impact will be assessed at baseline and after 3 months using the International Incontinence Questionnaire Short Form (ICIQ-SF).
Measured: Three months
Secondary outcomes (1)
Quality of life in Women with Multiple Sclerosis
The impact of incontinence on quality of life will be assessed at baseline and after 3 months using the Incontinence Quality of Life Scale (I-QOL).
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Jul 2024
- Primary completion1 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nurgül KAPLAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nurgül KAPLAN, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805331
- Sponsor's protocol ID
- GaziosmanpasaU- HMŞRLK-NK-01
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Belief Model-Based Pelvic Floor Muscle Exercise Training on Urinary Incontinence and Quality of Life in Female Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06805331
- Acronym / sponsor ID
- GaziosmanpasaU- HMŞRLK-NK-01
- Conditions
- Multiple Sclerosis, Urinary Incontinence
- Keywords
- Exercise training, Multiple Sclerosis, Pelvic Floor Muscle Exercise, Health Belief Model, Urinary Incontinence, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Nurgül KAPLANUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Feb 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 aim of this study is to evaluate the effect of Pelvic Floor Muscle Exercise Training According to the Health Belief Model on Urinary Incontinence and Quality of Life in Female Patients with Multiple Sclerosis.
Hypothesis 01: Pelvic floor muscle exercise training applied using the health belief model is not effective in reducing urinary complaints in female MS patients.
Hypothesis 1: Pelvic floor muscle exercise training applied using the health belief model is effective in reducing urinary complaints in female MS patients.
Hypothesis 02: Pelvic floor muscle exercise training applied using the health belief model is not effective on the quality of life of female MS patients.
Hypothesis 2: Pelvic floor muscle exercise training applied using the health belief model is effective on the quality of life of female MS patients.
Detailed description
This study will be conducted to evaluate the effect of pelvic floor muscle exercise (PFMT) training on urinary incontinence and quality of life in women with multiple sclerosis (MS) according to the health belief model (HBM). This study will be conducted as a randomized controlled experimental study with 46 women with urinary incontinence complaints who were diagnosed with MS and followed up at the MS outpatient clinic of the Neurology Department of Tokat Gaziosmanpaşa University Hospital. Patients will be included in the control (23) and intervention (23) groups by simple randomization method. In collecting the research data; Questionnaire on Descriptive Characteristics, International Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Quality of Life Scale (I-QOL), Incontinence Severity Index (ISI), Broome Pelvic Floor Muscle Exercise Self-Efficacy Scale (Broome PMSES), Expanded Disability Status Scale (EDSS), Bladder diary will be used. The research data will be collected after the experimental and control groups are determined after the approval. Data collection forms will be applied to both groups at the beginning of the study and at the end of the 1st and 3rd months. Patients in the intervention group will perform pelvic floor muscle exercises 3 times a day (morning-afternoon-evening) for 3 months. No intervention will be applied to patients in the control group. The data will be entered into a statistical package program and evaluated. No study has been found in the literature evaluating the effect of PTCE training according to the SIM on urinary incontinence and quality of life in female patients with MS. The research has original value in this respect and will contribute scientifically to national and international literature. If the research is successful, it is thought that PTCE training according to the health belief model in female patients with MS will be proven as a non-pharmacological intervention and will provide a new nursing intervention in the field. PTCE training according to the SIM in female patients with MS will reduce urinary incontinence and increase quality of life. In addition, it is thought that it will contribute positively to the physiological, psychological and social recovery process of MS patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized-controlled
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Pelvic Floor Muscle Exercise Training) | Experimental | Behavioral: Intervention group(Pelvic Floor Muscle Exercise Training)The researcher will explain pelvic floor muscle exercises to the patients within the framework of the health belief model. After the pelvic floor muscle exercise training is given, the patients will be asked to do these exercises three times a day (morning-afternoon-evening) for three months (12 weeks). |
| No Intervention (Control Group) | Other | Other: control groupParticipants in the control group will undergo standard care procedures without receiving any intervention. The results will be evaluated for comparison purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being 18 years old and above,
- Being a woman,
- Being diagnosed with MS,
- Having urinary incontinence,
- Not having an attack in the last thirty days,
Key exclusion criteria (10 listed)
- Presence of pregnancy,
- Presence of urinary tract infection,
- Presence of another neurological disease that may cause incontinence,
- History of cancer,
- History of pelvic surgery,
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 |
|---|---|---|
| Intervention group(Pelvic Floor Muscle Exercise Training)The intervention will involve educating participants on pelvic floor muscle exercises, using the health belief model. The goal is to evaluate improvements in incontinence severity, quality of life, and pelvic floor muscle exercise self-efficacy | Behavioural | Intervention Group (Pelvic Floor Muscle Exercise Training) |
| control groupParticipants in the control group will continue to receive their current standard of care and will not receive any additional interventions. | Other | No Intervention (Control Group) |
Primary outcome
Urinary Incontinence
Time frame: Three months
Urinary incontinence severity and impact will be assessed at baseline and after 3 months using the International Incontinence Questionnaire Short Form (ICIQ-SF).
1 secondary outcome
Quality of life in Women with Multiple Sclerosis
Time frame: Three months
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 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group(Pelvic Floor Muscle Exercise Training) in people with Multiple Sclerosis and Urinary Incontinence, run by Nurgül KAPLAN 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 9 inclusion and 10 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 Oct 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?
Urinary Incontinence (time frame: Three months). 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 Oct 2026.