Clinical trial NCT04758468: Effects of Telerehabilitation-Based Pelvic Floor Muscle Training in People With Multiple Sclerosis
Official title: Effects of Telerehabilitation-Based Pelvic Floor Muscle Training on Urinary Incontinence, Sexual Function and Quality of Life in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Urinary Incontinence
Keywords: Multiple Sclerosis
Urinary Incontinence
Pelvic Floor Muscle Training
Sexual Function
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Izmir Katip Celebi University
First posted: 2021-02-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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. 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.

The participants will randomly be allocated into three groups: (1) Telerehabilitation-based pelvic floor muscle training, (2) Home-based pelvic floor muscle training, and (3) Control group 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. The home-based pelvic floor muscle training group will do their individual exercises 3 times a day for 8 weeks. The control group will receive no specific training

Detailed description: Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks, but the home-based group will follow the exercise protocol individually while the telerehabilitation-based group will follow the telerehabilitation-based under the guidance of the physiotherapist.

Exercises will be applied 3 times a day according to the specified protocol. An information leaflet will be distributed to the home exercise group. The telerehabilitation-based group will receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist individually for 2 sessions a week, the patient will do the exercises twice a day in the days of the sessions with the physiotherapist, and the remaining days will continue to do it 3 times a day like a home exercise group. The control group will not receive treatment other than their routine treatment, and the patients will be informed that they will be treated if they wish at the end of the study.

The progression in Pelvic Floor Muscle Training will be achieved by increasing the exercise volume and diversifying the positions. The assessments will be applied at baseline, 4, 8, and 12 weeks.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility of the methods-minimum recruitment rate
timeFrame: Through Study Completion, an Average of 8 Weeks
measure: Feasibility of the methods-minimum retention rate
timeFrame: Through Study Completion, an Average of 8 Weeks
measure: Feasibility of the methods-minimum adherence rate
timeFrame: Through Study Completion, an Average of 8 Weeks
measure: Feasibility of the methods-adverse events
timeFrame: Through Study Completion, an Average of 8 Weeks
measure: Change in Leakage Episodes
timeFrame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
Secondary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: The assessment will be applied at baseline.
measure: Change in Patient-Determined Disease Steps Scale (PDDS) Score
timeFrame: The assessments will be applied at baseline and 8 weeks.
measure: Change in Brief International Cognitive Assessment for MS-Symbol Digit Modalities Test Score
timeFrame: The assessments will be applied at baseline and 8 weeks.
measure: Change in Brief International Cognitive Assessment for MS-California Verbal Learning Test-Second Edition Score
timeFrame: The assessments will be applied at baseline and 8 weeks.
measure: Change in Brief International Cognitive Assessment for MS-Brief Visuospatial Memory Test-Revised Score
timeFrame: The assessments will be applied at baseline and 8 weeks.
measure: Change in Pad Usage
timeFrame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
measure: Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Score
timeFrame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
measure: Change in Overactive Bladder-Validated 8-Question (OAB-V8) Score
timeFrame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
measure: Change in EuroQOL 5-Dimension 3-Level Questionnaire Score
timeFrame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
measure: Change in Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19) Score
timeFrame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
measure: Change in Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
measure: Change in the number of falls due to a sense of urgency
timeFrame: The assessments will be applied at baseline and 8 weeks.
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Hospital, MS Outpatient Clinic
state: Inciralti
Study officials:
References: