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

Not Applicable

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Other: Exercise; Other: Lifestyle recommendations

• Registration Number: NCT04759391
• Lead Sponsor: Ataturk Training and Research Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2021-02
• Study Start: 2021-02
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-18
• Primary Completion: 2021-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Exercise	Lifestyle recommendations as well as digital pelvic floor muscle training to the exercise group
Control group	Lifestyle recommendations	Lifestyle recommendations will be given to the control group
Exercise group	Lifestyle recommendations	Lifestyle recommendations as well as digital pelvic floor muscle training to the exercise group

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ankara Yildirim Beyazit University; 🇹🇷 Ankara, Turkey