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

NCT06805331 | Completed

• 1 other identifier: GaziosmanpasaU- HMŞRLK-NK-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Urinary Incontinence

Keywords

Exercise training; Multiple Sclerosis; Pelvic Floor Muscle Exercise; Health Belief Model; Urinary Incontinence; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quality of life in Women with Multiple Sclerosis

  Three months

Other Outcomes (1)

• The Broome Pelvic Floor Muscle Exercise Self-Efficacy

  Three months

Study Arms (2)

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).

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.

Other: control group

Interventions

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

Intervention Group (Pelvic Floor Muscle Exercise Training)

control group OTHER

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

No Intervention (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: * Being a woman, * Being diagnosed with MS, * Having urinary incontinence,
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Nurgül KAPLAN: lead

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Incontinence

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know which group they are in. The person who analyzes the data obtained at the end of the study will not know the groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Model Details: Randomized-controlled

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 3, 2025
• Study Start: April 9, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 13, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TU (1)