Effects of Telerehabilitation-Based Pelvic Floor Muscle Training on Urinary Incontinence, Sexual Function and Quality of Life in People With Multiple Sclerosis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Dokuz Eylul University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Feasibility of the methods-minimum retention rate
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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;
- 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.
- 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.
Investigators
Turhan Kahraman
Associate Professor
Dokuz Eylul University
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.
Outcomes
Primary Outcomes
Feasibility of the methods-minimum retention rate
Time Frame: Through Study Completion, an Average of 8 Weeks
A target retention rate of 80% will be accepted as feasible.
Feasibility of the methods-minimum recruitment rate
Time Frame: Through Study Completion, an Average of 8 Weeks
A minimum recruitment rate of 10 participants per month will be accepted as feasible.
Feasibility of the methods-minimum adherence rate
Time Frame: Through Study Completion, an Average of 8 Weeks
A target minimum adherence rate of 70% of the overall practice sessions will be accepted as feasible.
Feasibility of the methods-adverse events
Time Frame: Through Study Completion, an Average of 8 Weeks
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.
Change in Leakage Episodes
Time Frame: The assessments will be applied at baseline, 4, 8, and 12 weeks.
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.
Secondary Outcomes
- Change in Brief International Cognitive Assessment for MS-Symbol Digit Modalities Test Score(The assessments will be applied at baseline and 8 weeks.)
- 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-Brief Visuospatial Memory Test-Revised Score(The assessments will be applied at baseline and 8 weeks.)
- Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Score(The assessments will be applied at baseline, 4, 8, and 12 weeks.)
- Change in Hospital Anxiety and Depression Scale (HADS) Score(The assessments will be applied at baseline, 4, 8, and 12 weeks.)
- Change in the number of falls due to a sense of urgency(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 Overactive Bladder-Validated 8-Question (OAB-V8) Score(The assessments will be applied at baseline, 4, 8, and 12 weeks.)
- Change in EuroQOL 5-Dimension 3-Level Questionnaire Score(The assessments will be applied at baseline, 4, 8, and 12 weeks.)
- Change in Pad Usage(The assessments will be applied at baseline, 4, 8, and 12 weeks.)
- Change in Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19) Score(The assessments will be applied at baseline, 4, 8, and 12 weeks.)