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NCT Number: 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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group(Pelvic Floor Muscle Exercise Training)

Behavioral

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 Group

Other

Participants in the control group will continue to receive their current standard of care and will not receive any additional interventions.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Quality of life in Women with Multiple Sclerosis

    Time frame: Three months

    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).

Other outcomes

  1. The Broome Pelvic Floor Muscle Exercise Self-Efficacy

    Time frame: Three months

    Individuals' self-efficacy beliefs regarding performing pelvic floor muscle exercises will be assessed using the Broome Pelvic Floor Muscle Exercise Self-Efficacy Scale at baseline and after 3 months.

Sponsors and collaborators

Lead sponsor

Nurgül KAPLAN

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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