Back to resultsEffects of Digital Pelvic Floor Muscle Training in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms
Primary Purpose
Lower Urinary Tract Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Lifestyle recommendations
Sponsored by
About this trial
This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring Lower Urinary Tract Symptoms, Multiple Sclerosis, Pelvic Floor Muscle Training
Eligibility Criteria
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
Sites / Locations
- Ankara Yildirim Beyazit University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise group
Control group
Arm Description
Lifestyle recommendations as well as digital pelvic floor muscle training to the exercise group
Lifestyle recommendations will be given to the control group
Outcomes
Primary Outcome Measures
Incontinence symtoms
Urinary incontinence symptoms will be evaluated with The International Consultation of Incontinence Questionnaire - Short Form
Overactive bladder symptoms
Overactive bladder symptoms will be evaluated with Overactive Bladder Questionnaire-Version8
Secondary Outcome Measures
bladder functions
bladder functions will be evaluated with voiding diary
Quality of life level
Quality of life will be evaluated with King's Health Questionnaire
subjective perception of improvement
subjective perception of improvement will be evaluated with a 4-item Likert-type scale
patient satisfaction
patient satisfaction will be evaluated with a 5-item Likert-type scale
Full Information
NCT ID
NCT04759391
First Posted
February 15, 2021
Last Updated
February 15, 2021
Sponsor
Ataturk Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04759391
Brief Title
Effects of Digital Pelvic Floor Muscle Training in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms
Official Title
Effects of Digital Pelvic Floor Muscle Training and Lifestyle Recommendations in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms
Keywords
Lower Urinary Tract Symptoms, Multiple Sclerosis, Pelvic Floor Muscle Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly divided into two groups (control and exercise) for treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Lifestyle recommendations as well as digital pelvic floor muscle training to the exercise group
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Lifestyle recommendations will be given to the control group
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Pelvic floor muscle training program planned under the supervision of a physiotherapist was applied and followed to the exercise group, using the digital application.
Intervention Type
Other
Intervention Name(s)
Lifestyle recommendations
Intervention Description
Information was given within the scope of lifestyle recommendations (fluid intake, diet, constipation, weight control, smoking related to lower urinary system symptoms
Primary Outcome Measure Information:
Title
Incontinence symtoms
Description
Urinary incontinence symptoms will be evaluated with The International Consultation of Incontinence Questionnaire - Short Form
Time Frame
change from baseline at 8 weeks
Title
Overactive bladder symptoms
Description
Overactive bladder symptoms will be evaluated with Overactive Bladder Questionnaire-Version8
Time Frame
change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
bladder functions
Description
bladder functions will be evaluated with voiding diary
Time Frame
change from baseline at 8 weeks
Title
Quality of life level
Description
Quality of life will be evaluated with King's Health Questionnaire
Time Frame
change from baseline at 8 weeks
Title
subjective perception of improvement
Description
subjective perception of improvement will be evaluated with a 4-item Likert-type scale
Time Frame
after treatment (8th week)
Title
patient satisfaction
Description
patient satisfaction will be evaluated with a 5-item Likert-type scale
Time Frame
after treatment (8th week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda Toprak Celenay
Phone
+90312 906 1000
Email
sydtoprak@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda Toprak Celenay
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yildirim Beyazit University
City
Ankara
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seyda Toprak Celenay
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Digital Pelvic Floor Muscle Training in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms
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