Clinical trial NCT06805331: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Urinary Incontinence
Keywords: Exercise training
Multiple Sclerosis
Pelvic Floor Muscle Exercise
Health Belief Model
Urinary Incontinence
Quality of Life
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized-controlled
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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,
* 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,

Exclusion Criteria:

* 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,
* Deficiency in evaluation parameters,
* Non-compliance with treatment programs,
* Change in drug treatment during treatment,
* Receiving PTCE in the last six months

Primary outcomes:
measure: Urinary Incontinence
timeFrame: Three months
Secondary outcomes:
measure: Quality of life in Women with Multiple Sclerosis
timeFrame: Three months
Other outcomes:
measure: The Broome Pelvic Floor Muscle Exercise Self-Efficacy
timeFrame: Three months
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa University
Study officials:
References: