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

NCT04759391 | Unknown

• 1 other identifier: 2021/02/15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Lower Urinary Tract Symptoms; Multiple Sclerosis; Pelvic Floor Muscle Training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• bladder functions

  change from baseline at 8 weeks

• Quality of life level

  change from baseline at 8 weeks

• subjective perception of improvement

  after treatment (8th week)

• patient satisfaction

  after treatment (8th week)

Study Arms (2)

Exercise group

EXPERIMENTAL

Lifestyle recommendations as well as digital pelvic floor muscle training to the exercise group

Other: Exercise; Other: Lifestyle recommendations

Control group

ACTIVE COMPARATOR

Lifestyle recommendations will be given to the control group

Other: Lifestyle recommendations

Interventions

Exercise OTHER

Pelvic floor muscle training program planned under the supervision of a physiotherapist was applied and followed to the exercise group, using the digital application.

Exercise group

Lifestyle recommendations OTHER

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

Control group; Exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Seyda Toprak Celenay

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

+90312 906 1000; sydtoprak@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Participants will be randomly divided into two groups (control and exercise) for treatment.

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: February 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)