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Trial registered on ANZCTR


Registration number
ACTRN12608000633381
Ethics application status
Approved
Date submitted
14/08/2008
Date registered
15/12/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Women who cannot contract their pelvic floor muscles- avulsion or denervation? The Pelvic Floor Neuroanatomy Study
Scientific title
The Pelvic Floor neuroanatomy study. Using a 3 dimensional ultrasound to examine the pelvic floor muscle anatomy and using concentric EMG- electromyography to examine the pelvic floor muscles for damage/injury due to childbirth.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
women who cannot contract their pelvic floor muscles after pregnancy or childbirth including delivery by caesarean section. 3560 0
Condition category
Condition code
Musculoskeletal 3715 3715 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The women attending our clinics are routinely assessed for plevic floor muscle strength when they are examined vaginally. if they cannot contract their pelvic floor muscles, then they are eligible for enrollment in the study subject to their consent. They will all have had at least one visit with a physiotherapist prior to testing to ensure they have been taught the correct method to contract their muscles. The study consists of a 3/D(dimensional) ultrasound of pelvic floor muscles and an EMG (electromyography) of pelvic floor muscles .The women will undergo one ultrasound and one EMG study each over a 2 month period. each takes approximately 20 mins. This take place from when the participant is recruited and is not specific to time after childbirth. Many women present many years after childbirth.
Intervention code [1] 3273 0
Not applicable
Comparator / control treatment
Their is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4620 0
injury to pelvic floor muscle through childbirth using ultrasound and EMG assessment.
Timepoint [1] 4620 0
The injury will be assessed at the time of testing using ultrasound and EMG. The time point is when the women attend for these tests (within a 2 month period).
Secondary outcome [1] 7793 0
ultrasound will examine for loss of anatomy of the pelvic floor muscles due to trauma from childbirth and EMG will assess for nerve damage to the pelvic floor muscles also from childbirth.
Timepoint [1] 7793 0
the damage will be assessed at the time of testing using ultrasound and EMG. The time point is when the women attend for these tests (within a 2 month period).

Eligibility
Key inclusion criteria
women over 18 who cannot contract their pelvic floor muscles. Thses include all women who have had a pregnancy and a birth by caesarean section is not an exclusion.
Minimum age
18 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
previous surgery to the pelvis including prolapse repairs and incontinence surgery as well as hysterectomy.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3739 0
Hospital
Name [1] 3739 0
St Georga Public Hospital
Address [1] 3739 0
Gray St,
Kogarah
NSW,
2217,
Country [1] 3739 0
Australia
Primary sponsor type
Individual
Name
Prof Kate Moore
Address
level 1 Pitney Building,
St George Public Hospital,
Gray St,
Kogarah,
NSW,
2217
Country
Australia
Secondary sponsor category [1] 3353 0
None
Name [1] 3353 0
Address [1] 3353 0
Country [1] 3353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5792 0
South Eastern Sydney and Illawarra Area Health Service Human Research Ethics Committee
Ethics committee address [1] 5792 0
St George Hospital,
Gray St.,
Kogarah 2217
NSW
Ethics committee country [1] 5792 0
Australia
Date submitted for ethics approval [1] 5792 0
Approval date [1] 5792 0
15/08/2007
Ethics approval number [1] 5792 0
07/73 Moore

Summary
Brief summary
This study is an observational study looking at women who cannot contract their pelvic floor muscles. This study applies to all women who have had a pregnancy and includes those delivered by caesarean section.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28846 0
Address 28846 0
Country 28846 0
Phone 28846 0
Fax 28846 0
Email 28846 0
Contact person for public queries
Name 12003 0
Susmita Sarma
Address 12003 0
Pelvic Floor Unit, St George Public Hospital,
Cnr South and belgrave St,
Kogarah, NSW, 2217.
Country 12003 0
Australia
Phone 12003 0
+ 61 2 9113 2272
Fax 12003 0
+ 61 2 9113 3546
Email 12003 0
Sue.Sarma@SESIAHS.HEALTH.NSW.GOV.AU
Contact person for scientific queries
Name 2931 0
Susmita Sarma
Address 2931 0
Pelvic Floor Unit, St George Public Hospital,
Cnr South and Belgrave Sts,
Kogarah, NSW, 2217.
Country 2931 0
Australia
Phone 2931 0
+61 2 9113 2272
Fax 2931 0
+61 2 9113 3546
Email 2931 0
Sue.Sarma@SESIAHS.HEALTH.NSW.GOV.AU

No information has been provided regarding IPD availability
Summary results
No Results