Effects of Telerehabilitation-Based Pelvic Floor Muscle Training in People With Multiple Sclerosis

NCT04758468 | Completed

• 1 other identifier: 5742-GOA
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The effectiveness of pelvic floor muscle training on urinary incontinence and sexual function has been known for many years. However, the evaluation of its effectiveness in people with Multiple Sclerosis (MS) has recently begun and the level of evidence is limited. In addition, the applicability of pelvic floor muscle training based on telerehabilitation in the presence of a physiotherapist has not been investigated before. The aims of this study;

1. 1.The main aim of this study is to evaluate the feasibility and acceptability of telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist, which will be applied for the first time.
2. 2.Another aim is to compare this method with the effects of not receiving treatment other than usual treatment or receiving home-based pelvic floor muscle training on urinary incontinence, sexual dysfunction and psychosocial outcomes.

Conditions

Multiple Sclerosis; Urinary Incontinence

Keywords

Multiple Sclerosis; Urinary Incontinence; Pelvic Floor Muscle Training; Sexual Function

Outcome Measures

Primary Outcomes (5)

• Feasibility of the methods-minimum recruitment rate

  A minimum recruitment rate of 10 participants per month will be accepted as feasible.

  Through Study Completion, an Average of 8 Weeks

• Feasibility of the methods-minimum retention rate

  A target retention rate of 80% will be accepted as feasible.

  Through Study Completion, an Average of 8 Weeks

• Feasibility of the methods-minimum adherence rate

  A target minimum adherence rate of 70% of the overall practice sessions will be accepted as feasible.

  Through Study Completion, an Average of 8 Weeks

• Feasibility of the methods-adverse events

  A record sheet was prepared for possible adverse events during the tests and intervention. It includes information about seriousness, expectedness, severity, causality, time, duration of the event and clinical action taken. The numbers of adverse events will be reported.

  Through Study Completion, an Average of 8 Weeks

• Change in Leakage Episodes

  The bladder diary is a form that is used to objectively evaluate the frequency and severity of urinary incontinence. It will be used to determine the leakage episodes. It will be filled in three days by the patients. The amount of fluid taken in the diary, the amount of urine, the number of incontinence and pad change are recorded.

  The assessments will be applied at baseline, 4, 8, and 12 weeks.

Secondary Outcomes (12)

• Expanded Disability Status Scale (EDSS)

  The assessment will be applied at baseline.

• Change in Patient-Determined Disease Steps Scale (PDDS) Score

  The assessments will be applied at baseline and 8 weeks.

• Change in Brief International Cognitive Assessment for MS-Symbol Digit Modalities Test Score

  The assessments will be applied at baseline and 8 weeks.

• Change in Brief International Cognitive Assessment for MS-California Verbal Learning Test-Second Edition Score

  The assessments will be applied at baseline and 8 weeks.

• Change in Brief International Cognitive Assessment for MS-Brief Visuospatial Memory Test-Revised Score

  The assessments will be applied at baseline and 8 weeks.

Study Arms (3)

Telerehabilitation-based pelvic floor muscle training

EXPERIMENTAL

Behavioral: Telerehabilitation-based pelvic floor muscle training

Home-based pelvic floor muscle training

ACTIVE COMPARATOR

Behavioral: Home-based pelvic floor muscle training

Control (no specific intervention)

NO INTERVENTION

Interventions

Telerehabilitation-based pelvic floor muscle training BEHAVIORAL

Telerehabilitation-based pelvic floor muscle training group will individually receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist 2 sessions per week for 8 weeks. Participants will do their exercises themselves 2 times on the days where sessions are held with a physiotherapist. Participants will continue to exercise 3 times a day in the remaining days. Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks.

Telerehabilitation-based pelvic floor muscle training

Home-based pelvic floor muscle training BEHAVIORAL

The home-based pelvic floor muscle training group will do their individual exercises 3 times a day for 8 weeks. Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks.

Home-based pelvic floor muscle training

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 been diagnosed with MS according to McDonald diagnostic criteria
• Having urinary incontinence
• EDSS score less than 8
• Have the cognitive capacity to complete the assessment and treatment protocol

You may not qualify if:

• Pregnancy
• Pelvic surgery history
• A history of cesarean or vaginal delivery within 6 months prior to the study
• Progressive disability (1 point increase in EDSS) or attacks in the last 3 months
• Having received pelvic floor muscle training in the last 6 months
• Have had or are receiving treatment for pelvic organ prolapse Patients receiving pharmacological therapy for incontinence whose dose has not changed over the past 3 months will be included, but will be excluded if the dose changes during the study.

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Izmir Katip Celebi University: collaborator

Study Sites (1)

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, Inciralti, 35340, Turkey (Türkiye)

Location

Related Publications (1)

• Yavas I, Kahraman T, Sagici O, Ozdogar AT, Yigit P, Baba C, Ozakbas S. Feasibility of Telerehabilitation-Based Pelvic Floor Muscle Training for Urinary Incontinence in People With Multiple Sclerosis: A Randomized, Controlled, Assessor-Blinded Study. J Neurol Phys Ther. 2023 Oct 1;47(4):217-226. doi: 10.1097/NPT.0000000000000448. Epub 2023 Jun 12.

  PMID: 37306430 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Incontinence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 17, 2021
• Study Start: February 18, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)