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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]

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

Condition category

Condition code

Renal and Urogenital

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]

Other interventions

Comparator / control treatment

Ankle neutral (barefeet) will be considered as the control condition.

Control group

Active

Outcomes

Primary outcome [1]

Transperenial ultrasound (TPS)

Timepoint [1]

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]

Vaginal manometer will be used to measure intra-vaginal closure pressure

Timepoint [2]

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]

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]

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]

Spinal mouse for pelvic tilt. Besides spinal curvature, the spinal mouse also measures pelvic tilt in sagittal plane

Timepoint [2]

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]

Feasibility measure: recruitment rate

Timepoint [3]

Recruitment rate: time frame needed to recruit the required number of participants

Secondary outcome [4]

Feasibility measure: compliance with study protocol

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Hong Kong

State/province [1]

Kowloon

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Hong Kong Polytechnic University

Address [1]

QT512, 5/F, Core T,
Hung Hom
Kowloon

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Human Subjects Ethics Sub-committee

Ethics committee address [1]

The Hong Kong Polytechnic University
404, 4/F, Block Z
Hung Hom
Kowloon
Hong Kong

Ethics committee country [1]

Hong Kong

Date submitted for ethics approval [1]

10/05/2017

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Use of high-heeled footwear began more than 1000 years back, and resulted in the development of changes in gait, posture and the kinematics and kinetics of the spine, hip, knees, and ankle. High-heeled shoes force the ankle into plantar flexion which leads to changes in lumbar spine, pelvic tilt, and other joints. High-heeled shoes induced plantar flexion has also been found to alter the activity of pelvic floor muscles (PFM) through its effect on lordosis of the lumbar spine and pelvic inclination (tilt). Several studies have evaluated the influence of high-heeled shoes on lumbar lordosis however, results are controversial. Some studies found an increase lumbar lordosis angle and some found a decrease or no change with increased heel height. It is reported that there might be an epidemiological association between lumbopelvic posture and urinary incontinence in women. Assuming a hyper or hypolordotic posture is thought to distort the PFM activity; hyperlordosis resulted in lengthening and hypolordosis resulted in a shortening of the PFM. The proposed mechanism is, in hypo-lordosis the pelvis tilts posteriorly causing the sacrum to move in an anterior and inferior direction and pubis in a posterior and superior direction drawing closer the attachment of the key PFMs, resulting in shortening of the muscle; and in hyperlordosis the reverse of this is thought to occur causing a stretch of the muscle. 
The evidence for the effect of various ankle positions on PFM activity is limited. To our knowledge only three studies have evaluated the effect of various ankle positions on PFM activity with controversial results. 
We hypothesize that passive plantar flexion induced by high-heeled shoes might decrease the activity of PFM through its effect on lumbar spine and pelvis in women. If women habitually wear high-heeled shoes, this might have the potential to reduce the activity and length of the PFM and deconditioning which might contribute to stress urinary incontinence. Paucity of literature and contradicting results of available literature on the impact of various ankle positions on lumbar spine, pelvis and PFM activity has led the authors to conduct this study. This study will determine the effect of four ankle positions (two plantar flexion positions induced by 5.08 cm (2 inches) and 7.62 cm (3 inches) high-heeled shoes; a neutral and a dorsiflexion position) on bioelectric and contractile activity of PFM. 
The primary aim of this study is to assess the influence of high-heeled shoes induced plantar flexion on bioelectrical and contractile activity of PFM and compare it to ankle neutral and dorsiflexion positions. The secondary aim is to assess the effect the four ankle positions on lumbar lordosis and pelvic tilt.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Priya Kannan

Address

ST 532, Core S
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Kowloon

Country

Hong Kong

Phone

+852 3400 3277

Fax

priya.kannan@polyu.edu.hk

Contact person for public queries

Name

Priya Kannan

Address

ST 532, Core S
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Kowloon

Country

Hong Kong

Phone

+852 3400 3277

Fax

priya.kannan@polyu.edu.hk

Contact person for scientific queries

Name

Priya Kannan

Address

ST 532, Core S
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Kowloon

Country

Hong Kong

Phone

+852 3400 3277

Fax

priya.kannan@polyu.edu.hk

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

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Documents added automatically

No additional documents have been identified.

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