None listed
Conditions
Brief summary
Lower urinary tract dysfunction affects 50-90% of people with Multiple Sclerosis at some stage through the course of the disease. It is a serious medical condition with a severe social impact, causing embarrassment and negative self-perception. Urinary incontinence can be treated with: conservative or pharmaceutical intervention, surgery or pelvic floor muscle trainig (PFMT). PFMT may consist of exercises or intravaginal electrical stimulation. The aim of this study is evaluate the effects of this intervention on patients with Multiple sclerosis. This is an experimental trial with a sample of 60 subjects. Each subject is randomized assigned to the experimental group or to the control group. The experimental group receives the treatment: a home-dairy session of 30 minutes’ intravaginal electrical stimulation with Neurotrac ™ during 9 week. The control group receives no treatment. The outcomes are: power and endurance of pelvic floor measured by with Neurotrac ™ETS; urinary leakages measured with a week- bladder diary and quality of life measured with MusiQoL and SF-36 questionnaire. Data are registered before and after the intervention with a 3-month follow-up.
Interventions
The intervention consists in intravaginal electrical stimulation using Neurotrac™Sport XL, which is a dual channel stimulador with the reduced pulse width. 50 – 330 µS. The physiotherapist programs the device with the follow parameters: frequency:=25 Hz; pulse duration= 330 us; time= 20 min; 20-s on/40-s off cycles.
The intervention is carried out daily during 9 weeks at home by the subject, who inserts alone the intravaginal electrode, which is connecting with the device, and starts the session
The intervention consists in intravaginal electrical stimulation using Neurotrac™Sport XL, which is a dual channel stimulador with the reduced pulse width. 50 – 330 µS. The physiotherapist programs the device with the follow parameters: frequency:=25 Hz; pulse duration= 330 us; time= 20 min; 20-s on/40-s off cycles. The intervention is carried out daily during 9 weeks at home by the subject, who inserts alone the intravaginal electrode, which is connecting with the device, and starts the session. One sesion a week under physiotherapist supervision in the hospital. The adherence is monitored by a home-diary.
Sponsors
Virgen Macarena University Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Subject with a definitive diagnosis of Multiple Sclerosis with a stable disease over the previous four months; - 18 years of age or older; - EDSS score less than or equal to 6.5; - Cognitive capacity to complete the assessment and the treatment protocol; - Reporting lower urinary tract symptoms ( define by present of leakges measured by a week-bladder diary).
Exclusion criteria
- Pregnancy - No cognitive capacity to complete the assessment and the treatment protocol; - EDSS score more than 6.5 - MS relapse during treatment (defined as any change in symptoms according to the EDSS evaluation); - Pelvic organ prolapsed (detected during the vaginal examination) of grade II or more; - Urinary tract infection (confirmed by lab tests).
Outcome results
None listed