Effects of Digital Pelvic Floor Muscle Training in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms

Effects of Digital Pelvic Floor Muscle Training and Lifestyle Recommendations in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms

The aim of this study was to investigate the effects of digital pelvic floor muscle training and lifestyle recommendations in patients with Multiple Sclerosis having lower urinary tract symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: Other: Exercise; Other: Lifestyle recommendations

Detailed Description

Multiple sclerosis (MS) is an autoimmune, neurodegenerative disease of the central nervous system. Lower urinary tract symptoms (LUTS) are very common in MS. Pelvic floor muscle training (PFMT) is one of the first-line choices for the conservative treatment of LUTS.

According to our knowledge, no study has investigated the effects of digital pelvic floor muscle training and lifestyle recommendations in MS having LUTS, yet.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara Yildirim Beyazit University
    • Contact: Seyda Toprak Çelenay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Having a diagnosis of MS and having at least two of the lower urinary symptoms
• Not having an attack in the last 1 month,
• No change in medical treatment in the last 3 months
• "Expanded disability status scale-EDSS" score is less than 6.5
• Not having any cognitive problems that would hinder cooperation and understanding
• Those who use digital devices such as computers, laptops, smartphones and tablets
• Volunteering to participate in the study

Exclusion Criteria:

• Pregnancy status
• Active urinary tract infection
• Another neurological disease that can cause incontinence
• A history of malignancy
• Prostate surgery
• Those with missing evaluation parameters
• Those who do not regularly participate in treatment programs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; Lifestyle recommendations as well as digital pelvic floor muscle training to the exercise group	Other: Exercise; Pelvic floor muscle training program planned under the supervision of a physiotherapist was applied and followed to the exercise group, using the digital application.; Other: Lifestyle recommendations; Information was given within the scope of lifestyle recommendations (fluid intake, diet, constipation, weight control, smoking related to lower urinary system symptoms
Active Comparator: Control group; Lifestyle recommendations will be given to the control group	Other: Lifestyle recommendations; Information was given within the scope of lifestyle recommendations (fluid intake, diet, constipation, weight control, smoking related to lower urinary system symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incontinence symtoms	Urinary incontinence symptoms will be evaluated with The International Consultation of Incontinence Questionnaire - Short Form	change from baseline at 8 weeks
Overactive bladder symptoms	Overactive bladder symptoms will be evaluated with Overactive Bladder Questionnaire-Version8	change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bladder functions	bladder functions will be evaluated with voiding diary	change from baseline at 8 weeks
Quality of life level	Quality of life will be evaluated with King's Health Questionnaire	change from baseline at 8 weeks
subjective perception of improvement	subjective perception of improvement will be evaluated with a 4-item Likert-type scale	after treatment (8th week)
patient satisfaction	patient satisfaction will be evaluated with a 5-item Likert-type scale	after treatment (8th week)

Collaborators and Investigators

• Sponsor: Ataturk Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Lower Urinary Tract Symptoms; Pelvic Floor Muscle Training
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urological Manifestations; Multiple Sclerosis; Sclerosis; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 2021/02/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No