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

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04759391
• Other study ID #: 2021/02/15
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: July 2021

Study information

• Verified date: February 2021
• Source: Ataturk Training and Research Hospital
• Contact: Seyda Toprak Celenay
• Phone: +90312 906 1000
• Email: sydtoprak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Multiple Sclerosis
• Sclerosis

Intervention

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.
• Lifestyle recommendations
Information was given within the scope of lifestyle recommendations (fluid intake, diet, constipation, weight control, smoking related to lower urinary system symptoms

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinence symtoms	Urinary incontinence symptoms will be evaluated with The International Consultation of Incontinence Questionnaire - Short Form	change from baseline at 8 weeks
Primary	Overactive bladder symptoms	Overactive bladder symptoms will be evaluated with Overactive Bladder Questionnaire-Version8	change from baseline at 8 weeks
Secondary	bladder functions	bladder functions will be evaluated with voiding diary	change from baseline at 8 weeks
Secondary	Quality of life level	Quality of life will be evaluated with King's Health Questionnaire	change from baseline at 8 weeks
Secondary	subjective perception of improvement	subjective perception of improvement will be evaluated with a 4-item Likert-type scale	after treatment (8th week)
Secondary	patient satisfaction	patient satisfaction will be evaluated with a 5-item Likert-type scale	after treatment (8th week)