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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

Pas encore en recrutement
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L'étude clinique NCT06805331 est un essai interventionnel pour Sclérose en plaques, Incontinence urinaire. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 9 avril 2025, avec un objectif de 46 participants. Dirigé par Nurgül KAPLAN, l'essai devrait être terminé d'ici le 13 juin 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 10 avril 2025.
Résumé succinct
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.

Description détaillée
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.
Titre officiel

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

Conditions
Sclérose en plaquesIncontinence urinaire
Autres identifiants de l'essai
  • GaziosmanpasaU- HMŞRLK-NK-01
Numéro NCT
Date de début (réel)
2025-04-09
Dernière mise à jour publiée
2025-04-10
Date de fin (estimée)
2025-06-13
Inscription (estimée)
46
Type d'essai
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Exercise training
Multiple Sclerosis
Pelvic Floor Muscle Exercise
Health Belief Model
Urinary Incontinence
Quality of Life
Objectif principal
Soins de soutien
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalIntervention 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).
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
AutreNo Intervention (Control Group)
Participants in the control group will undergo standard care procedures without receiving any intervention. The results will be evaluated for comparison purposes.
GROUPE TÉMOIN
Participants in the control group will continue to receive their current standard of care and will not receive any additional interventions.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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).
Three months
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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).
Three months
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Femme
  • 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,

  • 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
Nurgül KAPLAN logoNurgül KAPLAN
Partie responsable de l'essai
Nurgül KAPLAN, Promoteur-Investigateur, Instructor, Tokat Gaziosmanpasa University
Contact central de l'essai
Contact: Nurgül KAPLAN, Lecturer, +9005524001149, [email protected]
Contact: Mehtap TAN, Professor Doctor, +90 442 231 1339, [email protected]
1 Centres de l'essai dans 1 pays
Tokat Gaziosmanpaşa University, Tokat Province, Turkey (Türkiye)