Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000667314p
Ethics application status
Submitted, not yet approved
Date submitted
26/04/2017
Date registered
9/05/2017
Date last updated
14/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of high-heeled shoes on pelvic floor muscle activity in women with stress urinary incontinence
Scientific title
Impact of high-heeled shoes induced ankle plantar flexion on pelvic floor muscle activity in women with stress urinary incontinence
Secondary ID [1] 291130 0
None
Universal Trial Number (UTN)
U1111-1192-6648
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Stress Urinary Incontinence 301958 0
Condition category
Condition code
Renal and Urogenital 301609 301609 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non-pregnant women with stress urinary incontinence will attend a 3-hour testing session.
Resting and functional activity of pelvic floor muscles (PFM) using transperenial ultrasound (TPS), intra-vaginal pressure measurement using vaginal manometer and evaluation of lumbar lordosis and pelvic tilt using spinal mouse will be done in standing with ankle in four positions including: neutral ankle position (bare feet); 10-degree dorsiflexion with a wedge under toes; and two ankle plantar flexion positions.
Initially assessments using vaginal manometry, TPS and spinal mouse will be done in ankle neutral position condition for approximately 10-20 minutes. Following this, assessments will be repeated with ankle in 10-degree dorsiflexion, assessment lasting for about 10-20 minutes. Women will then be made to stand or walk (at participant’s discretion) around with 5.08 cm (2 inches) high-heeled shoes for 30 minutes (for possible postural adjustments) before measurements are repeated. Participants will then be made to wear the 7.62 cm (3 inches) high-heeled shoes for 30 minutes during which time they decide to stand or walk around following which measurements will be repeated. Between the two plantar flexion positions a 10-minute rest period will be provided. In each ankle position women will undergo 3D- (for resting PFM activity) and 4D-TPS (for obtaining images at maximum PFM (2) contraction) using the GE Healthcare/Logiq TPS system with a 2-5.5 HMz probe. A five-minute rest period will be allowed between measurements in the consecutive ankle neutral and dorsiflexion conditions.
All assessments will be done at the physiotherapy Department of Kwong Wah Hospital by a physiotherapist with specialist experience in Women's health and assisted by another physiotherapist with expertise in TPS.
Intervention code [1] 297885 0
Other interventions
Comparator / control treatment
Ankle neutral (barefeet) will be considered as the control condition.
Control group
Active

Outcomes
Primary outcome [1] 302347 0
Transperenial ultrasound (TPS)
Timepoint [1] 302347 0
Each participant will be requested to void prior to testing. In each ankle position women will undergo 3D- (for resting PFM activity) and 4D-TPS (for obtaining images at maximum PFM (2) contraction) using the GE Healthcare/Logiq TPS system with a 2-5.5 HMz probe. In total TPS recording will not last for more than 5 minutes.
Primary outcome [2] 302750 0
Vaginal manometer will be used to measure intra-vaginal closure pressure
Timepoint [2] 302750 0
Each participant will be requested to void prior to testing. Once participant is ready their intra-vaginal closure pressure will be measured using a vaginal manometer. In total vaginal manometer measurements will not last for more than 5 minutes.
Secondary outcome [1] 334179 0
Spinal mouse for measurement of lumbar lordosis. The spinal mouse is an hand-held computer aided electromechanical instrument used to measure spinal curvatures in sagittal plane
Timepoint [1] 334179 0
Lumbar lordosis will be measured in standing with ankles in four different positions: neutral (neutral), dorsiflexion and two plantar flexion). In each ankle position testing will be done for 5-10 minutes.
Secondary outcome [2] 334486 0
Spinal mouse for pelvic tilt. Besides spinal curvature, the spinal mouse also measures pelvic tilt in sagittal plane
Timepoint [2] 334486 0
Pelvic tilt will be measured in standing with ankles in four different positions: neutral (neutral), dorsiflexion and two plantar flexion). In each ankle position testing will be done for 5-10 minutes.
Secondary outcome [3] 336902 0
Feasibility measure: recruitment rate
Timepoint [3] 336902 0
Recruitment rate: time frame needed to recruit the required number of participants
Secondary outcome [4] 336903 0
Feasibility measure: compliance with study protocol
Timepoint [4] 336903 0
Participants willingness for assessment of PFM activity using TPS and vaginal manometer and wearing high-heeled shoes for 30 minutes

Eligibility
Key inclusion criteria
Non-pregnant women with stress urinary incontinence in the age group of 18-49 years will be included.
Participants need not be habitual high-heeled shoes users to participate in the study.
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with previous pelvic surgeries, body mass index over 30 kg/m2, diabetes, smoking, chronic lung diseases, neurological problems, and urinary tract infection will be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Within group data of vaginal pressure and TPS activity of PFM in dorsiflexion and neutral positions will be compared with two plantar flexion positions using one-way analysis of variance (ANOVA) for parametric data. Kruskal Wallis analysis will be used for non-parametric data. Statistical significance will be achieved as a=0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/06/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 8846 0
Hong Kong
State/province [1] 8846 0
Kowloon

Funding & Sponsors
Funding source category [1] 296280 0
University
Name [1] 296280 0
The Hong Kong Polytechnic University
Country [1] 296280 0
Hong Kong
Primary sponsor type
Individual
Name
Dr Priya Kannan
Address
QT512, 5/F, Core T,
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Kowloon
Country
Hong Kong
Secondary sponsor category [1] 295200 0
None
Name [1] 295200 0
Address [1] 295200 0
Country [1] 295200 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297513 0
Human Subjects Ethics Sub-committee
Ethics committee address [1] 297513 0
Ethics committee country [1] 297513 0
Hong Kong
Date submitted for ethics approval [1] 297513 0
10/05/2017
Approval date [1] 297513 0
Ethics approval number [1] 297513 0

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

Contacts
Principal investigator
Name 72342 0
Dr Priya Kannan
Address 72342 0
ST 532, Core S
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Kowloon
Country 72342 0
Hong Kong
Phone 72342 0
+852 3400 3277
Fax 72342 0
Email 72342 0
[email protected]
Contact person for public queries
Name 72343 0
Priya Kannan
Address 72343 0
ST 532, Core S
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Kowloon
Country 72343 0
Hong Kong
Phone 72343 0
+852 3400 3277
Fax 72343 0
Email 72343 0
[email protected]
Contact person for scientific queries
Name 72344 0
Priya Kannan
Address 72344 0
ST 532, Core S
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Kowloon
Country 72344 0
Hong Kong
Phone 72344 0
+852 3400 3277
Fax 72344 0
Email 72344 0
[email protected]

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.