Effects of Telerehabilitation-Based Pelvic Floor Muscle Training on Urinary Incontinence, Sexual Function and Quality of Life in People With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT04758468

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Telerehabilitation-based pelvic floor muscle training

Compared with

  • Home-based pelvic floor muscle training

What it measured

Main measures

  • Feasibility of the methods-minimum recruitment rate

    Through Study Completion, an Average of 8 Weeks

    Feasibility
  • Feasibility of the methods-minimum retention rate

    Through Study Completion, an Average of 8 Weeks

    Feasibility
  • Feasibility of the methods-minimum adherence rate

    Through Study Completion, an Average of 8 Weeks

    Quality of life (reported by participants)Feasibility
  • Feasibility of the methods-adverse events

    Through Study Completion, an Average of 8 Weeks

    SafetyFeasibility
  • Change in Leakage Episodes

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

    Bladder, bowel and sexual function

Other measures (12)

  • Expanded Disability Status Scale (EDSS)

    The assessment will be applied at baseline.

    Disability progressionBladder, bowel and sexual function
  • Change in Patient-Determined Disease Steps Scale (PDDS) Score

    The assessments will be applied at baseline and 8 weeks.

    Disability progressionWalking and mobility
  • Change in Brief International Cognitive Assessment for MS-Symbol Digit Modalities Test Score

    The assessments will be applied at baseline and 8 weeks.

    Thinking and memory
  • 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.

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

    The assessments will be applied at baseline and 8 weeks.

    Thinking and memory
  • Change in Pad Usage

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

    Bladder, bowel and sexual function
  • Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Score

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

    Bladder, bowel and sexual functionQuality of life (reported by participants)
  • Change in Overactive Bladder-Validated 8-Question (OAB-V8) Score

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

    Bladder, bowel and sexual function
  • Change in EuroQOL 5-Dimension 3-Level Questionnaire Score

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

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)
  • Change in Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19) Score

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

    MRI lesionsBladder, bowel and sexual functionQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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History

    1. Started

      Feb 2021

    2. Main results due

      Nov 2021

    3. Finished

      Nov 2021

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