Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000861954
Ethics application status
Approved
Date submitted
11/07/2011
Date registered
15/08/2011
Date last updated
5/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomised controlled trial comparing pelvic floor treatment by a pelvic floor physiotherapist, versus extracorporeal magnetic stimulation, for women with stress urinary incontinence.
Scientific title
A prospective randomised controlled trial comparing pelvic floor treatment by a pelvic floor physiotherapist, versus extracorporeal magnetic stimulation, for pelvic floor strength, quality of life and severity of urinary incontinence, in patients with stress urinary incontinence
Secondary ID [1] 260049 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress urinary incontinence 265711 0
Condition category
Condition code
Physical Medicine / Rehabilitation 265851 265851 0 0
Physiotherapy
Renal and Urogenital 268436 268436 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Five individual treatment sessions by a pelvic floor physiotherapist including a tailored pelvic floor exercise program. The initial session will last one hour, while subsequent visits will be half an hour duration over a thjree month period.
Intervention code [1] 264467 0
Treatment: Other
Comparator / control treatment
Twenty treatments on a extracorporeal magnetic stimulator. These sessions may be two or three times per week, within a three month window. This involves the patient sitting on a neotonus chair, each visit lasting aproximately 25 minutes. Treatment consists of sitting on the chair and for 10 minutes receiving a 35 Hz current, followed by a 2-3 minute rest period, then a second period of stimulation of 10 Hz current for 10 minutes. Women will also be required to do pelvic floor exercises at home. They are provided with brief instruction on pelvic floor exercises and provided with a leaflet at there initial treatment session by a nurse continence advisor.
Control group
Active

Outcomes
Primary outcome [1] 266612 0
24 hour pad test
Timepoint [1] 266612 0
At the beginning of trial (at commencement of treatment), at four months (at completion of treatment) and again at six months.
Primary outcome [2] 266613 0
Pelvic floor muscle grading (using Modified Oxford scale) via a vaginal examiantion
Timepoint [2] 266613 0
At the beginning of the trial and at four months.
Secondary outcome [1] 276094 0
Quality of life score (ICIQ-SF)
Timepoint [1] 276094 0
At the beginning of the trial, at four months and again at six months.
Secondary outcome [2] 276095 0
Cost of treatment will be calculated by adding up the estimated cost of five physiotherapy treatment versus twenty chair sessions
Timepoint [2] 276095 0
At completion of trial

Eligibility
Key inclusion criteria
Women with a primary symptoms of stress urinary incontinence
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
People whose primary language is other than English
Women who are pregnant
Children/ young people (ie. under18 years)
People with an intellectual or mental impairment
People highly dependant on medical care
People with metal prosthesis

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)
Women with a predominate symptom of stress urinary incontinence will be given a brief outline by the referring doctor and asked if they are happy to be contacted regarding participation in a study.
If the patient consents they will be contacted by the research cordinator (myself) and given a more detailed outline of the study. If the patient agrees they are then given an appointment to meet and discuss the study, provided with written material, and formal consent is obtained.
Women are then randomised using a computer generated randomisation code.
At this initial appointment, women will be assessed by the Urogynecology staff specialist.
Prior to starting treatment they are also given a 24 hour pad test, ICIQ questionaire and 3 day bladder chart to complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267323 0
Self funded/Unfunded
Name [1] 267323 0
Country [1] 267323 0
Primary sponsor type
Hospital
Name
St George Hospital
Address
Pelvic Floor Unit
St George Hospital
Gray St
Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 266389 0
Individual
Name [1] 266389 0
Wendy Hayes
Address [1] 266389 0
Pelvic Floor Unit
St George Hospital
Gray St
Kogarah NSW 2217
Country [1] 266389 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269309 0
Human Research Ethics Commitee
Ethics committee address [1] 269309 0
Ethics committee country [1] 269309 0
Australia
Date submitted for ethics approval [1] 269309 0
Approval date [1] 269309 0
12/09/2009
Ethics approval number [1] 269309 0
HREC/09/STG/52

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32527 0
Address 32527 0
Country 32527 0
Phone 32527 0
Fax 32527 0
Email 32527 0
Contact person for public queries
Name 15774 0
Janette O'Toole
Address 15774 0
Pelvic Floor Unit
St George Hospital
Gray St
Kogarah NSW 2217
Country 15774 0
Australia
Phone 15774 0
+61 2 91132272
Fax 15774 0
Email 15774 0
janette.otoole@SESIAHS.HEALTH.NSW.GOV.AU
Contact person for scientific queries
Name 6702 0
Janette O'Toole
Address 6702 0
Pelvic Floor Unit
St George Hospital
Gray St
Kogarah NSW 2217
Country 6702 0
Australia
Phone 6702 0
+61 2 91132272
Fax 6702 0
Email 6702 0
janette.otoole@SESIAHS.HEALTH.NSW.GOV.AU

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.