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Trial registered on ANZCTR


Registration number
ACTRN12617001113347
Ethics application status
Approved
Date submitted
29/06/2017
Date registered
28/07/2017
Date last updated
28/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of urinary incontinence in subjects with multiple sclerosis using pelvic floor training based on intravaginal electrical stimulation: changes in urinary leakages and quality of life.
Scientific title
Effectiveness of a pelvic floor muscle training based on intravaginal electrical stimulation for the treatment of urinary incontinence in patients with multiple sclerosis
Secondary ID [1] 292190 0
' Nil known'
Universal Trial Number (UTN)
U1111-1197-9244
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 303667 0
Urinary Incontinence 303668 0
Condition category
Condition code
Renal and Urogenital 303366 303366 0 0
Other renal and urogenital disorders
Neurological 303468 303468 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298348 0
Treatment: Devices
Comparator / control treatment
'No treatment'
Control group
Active

Outcomes
Primary outcome [1] 302426 0
Urinary leakages, measuring with week-bladder diary
Timepoint [1] 302426 0
Before the intervention, at the end of the intervention and at 3 months after the intervention.
Primary outcome [2] 302427 0
Power of pelvic floor muscle measured with electromyography (Neurotrac ™ETS with an intra-vaginal biofeedback electrode).
Timepoint [2] 302427 0
Before the intervention, at the end of the intervention and at 3 months after the intervention.
Primary outcome [3] 302428 0
Endurance of pelvic floor muscle measured with electromyography (Neurotrac ™ETS with an intra-vaginal biofeedback electrode).
Timepoint [3] 302428 0
Before the intervention, at the end of the intervention and at 3 months after the intervention.
Secondary outcome [1] 335954 0
Quality of life assessed with MusiQoL and SF-36 and King’s health.
Timepoint [1] 335954 0
Before the intervention, at the end of the intervention and at 3 months after the intervention.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are derived from Multiple Sclerosis's Unit of Virgen Macarena University Hospital and , then randomly assigned to an intervention group (I) or control group (II). The method of allocations is a central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used to generate the sequence is “MAS Version 2.1 @Glazo Wellcome.”
This program did a randomized block: A/B.
Block design: AABB
Block size: 4
Block number: 15
Sample size: 60
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The experimental and the control group are composed by subjects with Multiple Sclerosis’s diagnostic who respond to Inclusion's Criteria.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size is 60 calculated by nQuery Advisor Program.
Statistical Analysis is going to be performed by PASW STATISTIC 18 for window.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9025 0
Spain
State/province [1] 9025 0
SEVILLE

Funding & Sponsors
Funding source category [1] 296727 0
Hospital
Name [1] 296727 0
FISEVI (Fundación pública Andaluz para la gestión de la Investigación en Salud de Sevilla)
Address [1] 296727 0
Avenida Manuel Siurot s/n. Edificio de Laboratorios 6º planta.
Seville 41013
Country [1] 296727 0
Spain
Primary sponsor type
Hospital
Name
Virgen Macarena University Hospital
Address
Avenida Doctor Frediani 3, 41009,seville (Spain)
Country
Spain
Secondary sponsor category [1] 295698 0
None
Name [1] 295698 0
Address [1] 295698 0
Country [1] 295698 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297955 0
Comité de Ética de la Investigación de Centro Hospital Universitario Virgen Macarena
Ethics committee address [1] 297955 0
Avenida Doctor Frediani 3- Unidad de Investigación 2ª planta, Seville 41071 Spain
Ethics committee country [1] 297955 0
Spain
Date submitted for ethics approval [1] 297955 0
15/07/2011
Approval date [1] 297955 0
27/07/2011
Ethics approval number [1] 297955 0
1659

Summary
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.
Trial website
Trial related presentations / publications
Poster " Effectiveness of a pelvic floor muscle training based on intravaginal electrical stimulation for the treatment of urinary incontinence in woman with multiple sclerosis a pilot study", Magni, E; Granja Dominguez, A;Hochsprung A; Escudero Uribe, S. RIMS Annual Reunion, Barcelona 04-06 May, 2017.
Public notes

Contacts
Principal investigator
Name 75566 0
Mrs Anja Hochsprung
Address 75566 0
FISEVI
Calle Fray Isidoro de Sevilla 1, 41003.
Seville
Spain

Country 75566 0
Spain
Phone 75566 0
+34 671562074
Fax 75566 0
Email 75566 0
ahalcala@hotmail.com
Contact person for public queries
Name 75567 0
Mrs Anja Hochsprung
Address 75567 0
FISEVI
Calle Fray Isidoro de Sevilla 1, 41003.
Seville
Spain
Country 75567 0
Spain
Phone 75567 0
+34 671562074
Fax 75567 0
Email 75567 0
ahalcala@hotmail.com
Contact person for scientific queries
Name 75568 0
Mrs Anja Hochsprung
Address 75568 0
FISEVI
Calle Fray Isidoro de Sevilla 1, 41003.
Seville
Spain
Country 75568 0
Spain
Phone 75568 0
+34 671562074
Fax 75568 0
Email 75568 0
ahalcala@hotmail.com

No data has been provided for results reporting
Summary results
Not applicable