ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000196549

Ethics application status

Approved

Date submitted

14/12/2023

Date registered

29/02/2024

Date last updated

28/07/2024

Date data sharing statement initially provided

29/02/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Pelvic floor muscle training for managing urinary incontinence in female athletes.

Scientific title

Pelvic floor muscle training for managing urinary incontinence in female athletes: a feasibility study.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Urinary incontinence

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

What: This intervention is a 12-week pelvic floor muscle (PFM) training program delivered using the femfit® intra-vaginal biofeedback device and accompanying phone application. The femfit® device will be used to measure intravaginal pressures. Participants will be taught to use the femfit® device when completing home-based exercises and will use their own mobile device to access the femfit application for their exercise program and adherence monitoring. This process will involve educating participants on how the femfit® device is inserted into the vagina, how to ensure correct placement using digital feedback on their phone application, how to access their exercise program and document completion in the exercise diary on the application, and how to maintain device hygiene. Processes for inserting and cleaning the femfit® device will be taught using the instructional videos embedded in the application.

Who: An AHPRA registered physiotherapist with pelvic floor knowledge will complete the intervention for all participants, regardless of delivery mode (face-to-face or telehealth). If needed, researchers with clinical pelvic floor experience will be available to complete sessions. All physiotherapists that will be delivering the intervention will be trained in the standardised intervention protocol, which will include attending face-to-face sessions with the researchers during which the protocol will be explained, use of the femfit® device will be taught and access and use of technology, including femfit.clinic (an online platform used for tailoring the PFMT program) and femfit.science (an online platform that pressure data recorded by the femfit® device can be extracted) will be taught. Researchers will assess standardisation of the delivery of the protocol.

How: Participants in both arms will undergo an initial face-to-face session (60 minutes) with the physiotherapist to confirm a correct pelvic floor muscle contraction using vaginal examination, teach use of the femfit® device, to ensure access to appropriate technology (ZoomTM, femfit® smartphone application, etc.) and determine exercise starting dosage. The physiotherapist will determine an appropriate starting dosage for each participant based on the assessment, which will include determining strength, endurance, and rapid contractions. The starting dosage will be entered into each participant’s femfit® program by the physiotherapist via femfit.clinic. All participants will then receive a further four individual follow up sessions (30 minutes) with the physiotherapist across 12 weeks to provide progressions, monitor adherence, explore barriers to adherence and discuss motivational strategies as appropriate. Participants will be expected to independently perform their home exercise program (HEP) between supervised sessions. Participants will be asked to complete their HEP five days per week, using the femfit® smartphone application to guide their exercises. Each session will include strength contractions, rapid contractions, podium (endurance) contractions and practice of a pre-emptive PFM contraction (known as ‘the knack’). Each exercise session will take roughly 10-20 minutes with the specific duration tailored to each participant. Individualised changes in dosage, position and addition of sports specific exercises will all be determined by the physiotherapist. The physiotherapist will input progressions or changes to a participant’s exercise program into femfit.clinic which will show on each participant’s femfit® application.

Where: All participants will attend their initial assessment session at a clinical room in Melbourne. Participants will be given the option to choose the mode of delivery for their follow up sessions, either face-to-face or via telehealth. We will aim to allocate a minimum of 10 participants to each delivery mode for feasibility outcomes only. All participants receive the same intervention regardless of delivery mode. Participants who elect to attend follow up sessions face-to-face will continue to attend the same location for their five remaining sessions. The clinical room will be set-up with a plinth and privacy screen for assessment. The participant will be asked to bring their femfit® device to all sessions. Participants who elect to attend follow up sessions on telehealth will complete the sessions from an appropriate private space, with the physiotherapist logging in on a laptop from an appropriate clinical location. Participants in the telehealth delivery mode will be asked to access ZoomTM from their smartphone which will allow them to later share their femfit® application screen. They will be instructed to have access to an area in which they can comfortably lie-down, sit or stand throughout the session and to have their femfit® device ready for use. The participant’s camera will be turned off during any use of the femfit® device. The physiotherapist will have access to the participant’s contact number for any issues with accessing ZoomTM.

When, How much: Participants will be asked to complete their HEP five times per week. The exercise program installed on the femfit® application is based on a published PFMT program and all participants will follow the three stages of this program. Each session will include four types of pelvic floor exercises all completed with the femfit® device to guide and record the exercises. As the program progresses through each phase the number of reps, duration of hold and exercise position will be progressed. Stage one will require participants to complete their exercises in a lying or sitting position, depending on the results of their initial assessment. Stage two will then be a progression to either sitting or standing. Stage three will be a progression to either standing or sports specific exercises.

Tailoring: Participants will receive treatment and exercises that are tailored to their level of progression through the exercise program. Tailoring will include progressing or regressing lengths of holds, repetitions and starting position based on information received from the femfit® device. If appropriate, participants may be given sports specific additions to their program (ie. positional, addition of exercise). Any tailoring will be explained and taught to the participant during the session. The researcher will then update the changes on the femfit.clinic online platform which will transfer onto the participant’s femfit® application.

How well: Participant adherence will be monitored through attendance to planned sessions with the physiotherapist and completion of their HEP, recorded by the femfit® smartphone application. Participants will receive an email in any week that they do not have a session with the researcher to encourage exercise adherence and monitor for any adverse events or participant questions. Participants will be taught how to perform a correct PFM contraction in the initial assessment session, and this can then be monitored/corrected through face-to-face assessment and/or the femfit® pressure biofeedback. This will assist in prompting good quality PFM contractions.
Fidelity of program delivery will be assessed as part of the intervention. This will be assessed by a researcher attending multiple sessions conducted by the physiotherapist, both face-face and on zoom. The sessions attended will be chosen at random and participants will be asked whether they consent to the researcher attending the session. The researcher will complete a checklist reviewing adherence to the protocol.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Rehabilitation

Intervention code [3]

Treatment: Other

Comparator / control treatment

No control group. This study include a single cohort, with the option to opt into different modes of delivery provided to participants. All participants receive the same intervention.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Recruitment rate.

Timepoint [1]

This outcome will be calculated at the end of the recruitment period.

Primary outcome [2]

Safety of PFMT intervention

Timepoint [2]

This outcome will be measured at the end of the 12 week intervention period.

Primary outcome [3]

Acceptability of the recruitment process

Timepoint [3]

This outcome will be measured at the end of the 12 week intervention period.

Secondary outcome [1]

Retention rate. This is a primary outcome measure.

Timepoint [1]

This outcome will be calculated at the conclusion of the study.

Secondary outcome [2]

Adherence rate. This is a primary outcome measure.

Timepoint [2]

This outcome will be calculated at the conclusion of the study.

Secondary outcome [3]

Withdrawal rate. This is a primary outcome measure.

Timepoint [3]

This outcome will be calculated at the conclusion of the study.

Secondary outcome [4]

Eligibility rate

Timepoint [4]

This outcome will be calculated at the end of the recruitment period.

Secondary outcome [5]

Consent rate. This is a primary outcome measure.

Timepoint [5]

This outcome will be calculated at the conclusion of the study.

Secondary outcome [6]

Frequency of urinary incontinence

Timepoint [6]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12 and 12 months later).

Secondary outcome [7]

Severity of urinary incontinence

Timepoint [7]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12 and 12 months later).

Secondary outcome [8]

Impact of urinary incontinence on participation and performance in sport

Timepoint [8]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12 and 12 months later).

Secondary outcome [9]

Urinary incontinence symptom bother

Timepoint [9]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12 and 12 months later).

Secondary outcome [10]

Satisfaction with treatment

Timepoint [10]

This outcome will be collected after the intervention (after week 12).

Secondary outcome [11]

Any change in participant's global impression of symptoms.

Timepoint [11]

This outcome will be collected after the intervention (after week 12).

Secondary outcome [12]

Change in symptoms and need for further treatment (composite outcome).

Timepoint [12]

This outcome will be collected after the intervention (after week 12).

Secondary outcome [13]

Duration of symptom changes.

Timepoint [13]

This outcome will be collected 12 months after completion of the intervention.

Secondary outcome [14]

Utilisation of additional urinary incontinence treatments

Timepoint [14]

This outcome will be collected 12 months after completion of the intervention.

Secondary outcome [15]

Adherence to home exercise program

Timepoint [15]

This outcome will be collected 12 months after completion of the intervention.

Secondary outcome [16]

Pelvic floor muscle strength

Timepoint [16]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12).

Secondary outcome [17]

Pelvic floor muscle voluntary contraction

Timepoint [17]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12).

Secondary outcome [18]

Pelvic floor muscle (levator ani) cross-sectional area.

Timepoint [18]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12).

Secondary outcome [19]

Pelvic floor muscle stiffness

Timepoint [19]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12).

Secondary outcome [20]

Attendance rate. This is a primary outcome measure.

Timepoint [20]

This outcome will be measured at the end of the 12 week intervention period.

Secondary outcome [21]

Data completion rate. This is a primary outcome measure.

Timepoint [21]

This outcome will be calculated at the conclusion of the study.

Secondary outcome [22]

Acceptability of outcome measures. This is a primary outcome measure.

Timepoint [22]

This outcome will be measured at the end of the 12 week intervention period.

Secondary outcome [23]

Acceptability of the intervention delivered via telehealth/in person sessions.
This is a primary outcome measure.

Timepoint [23]

This outcome will be measured at the end of the 12 week intervention period.

Secondary outcome [24]

Acceptability of the venue for intervention delivery (sports /exercise facilities).
This is a primary outcome measure.

Timepoint [24]

This outcome will be measured at the end of the 12 week intervention period.

Secondary outcome [25]

Consent rate for the internal examination. This is a primary outcome measure.

Timepoint [25]

This outcome will be calculated at the conclusion of the study.

Secondary outcome [26]

Consent rate for use of the femfit®. This is a primary outcome measure.

Timepoint [26]

This outcome will be calculated at the conclusion of the study.

Secondary outcome [27]

Consent rate for transperineal ultrasound. This is a primary outcome measure.

Timepoint [27]

This outcome will be calculated at the conclusion of the study.

Secondary outcome [28]

Consent rate for shearwave elastography. This is a primary outcome measure.

Timepoint [28]

This outcome will be calculated at the conclusion of the study.

Secondary outcome [29]

Pelvic floor muscle strength

Timepoint [29]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12).

Secondary outcome [30]

Pelvic floor muscle tone

Timepoint [30]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12).

Secondary outcome [31]

Pelvic floor muscle (levator ani) urogenital hiatus diameter.

Timepoint [31]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12).

Secondary outcome [32]

Pelvic organ descent.

Timepoint [32]

This outcome will be collected before the intervention (week 1) and after the intervention (after week 12).

Eligibility

Key inclusion criteria

Currently experience stress urinary incontinence (SUI) during sport
Only female pelvic floor anatomy at birth (female pelvic organs, female pelvic floor muscles and vagina)
18 years of age or older
Participate in any level of sport (competition or training) that includes high-impact activities (e.g. running, jumping, landing, cutting) or strength exercises (e.g. weight or power lifting) or contact activities (e.g. tackling) at least once per week
Sufficient English language skills to understand instructions from the researcher

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Neurological disorders (affecting pelvic organ function) or severe physical/psychiatric impairments that may impact on ability to undertake the intervention
Currently pregnant
Medication that has an effect on urinary incontinence
Pelvic surgery with aim to treat pelvic organ prolapse or urinary/faecal incontinence
Current or recent (within three months) pelvic floor treatment delivered by a qualified physiotherapist

Study design

Purpose of the study

Treatment

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

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Participant characteristics and summary scores from questionnaires at each time point will be reported descriptively using means and standard deviations for continuous data, and frequencies and percentages for categorical variables. A traffic light system will be utilised to assess all feasibility outcomes and the data will be presented as frequencies and percentages. Results of categorical data (satisfaction with treatment and 12 month follow up questions) will be presented as frequencies and percentages.

Pre and post scores from clinical outcome measures will be compared using paired t-tests (if parametric) or Wilcoxon Signed Rank test (if non-parametric) depending on the distribution of data, and mean change and standard deviation will be reported for each group. All analyses will be tested with a significance level of p<0.05 using SPSS 25.0 software (IBM Corp, Armonk, NY).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/03/2024

Actual

3/06/2024

Date of last participant enrolment

Anticipated

28/08/2025

Actual

Date of last data collection

Anticipated

31/12/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University in collaboration with Collingwood Football Club

Address [1]

Moorooduc Hwy, Frankston, Victoria 3199

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Moorooduc Hwy, Frankston, Victoria 3199

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University

Ethics committee address [1]

Moorooduc Hwy, Frankston, Victoria 3199

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/09/2023

Approval date [1]

21/11/2023

Ethics approval number [1]

40254

Summary

Brief summary

This study is aiming to determine the feasibility of delivering pelvic floor muscle training (in person vs. telehealth delivery) to treat urinary incontinence in female athletes.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you are currently experiencing stress urinary incontinence (urinary leakage) during sport, you had only female pelvic floor anatomy at birth, you participate in any level of sport (competition or training) that includes high-impact activities (e.g. running, jumping, landing, cutting) or strength exercises (e.g. weight or power lifting) or contact activities (e.g. tackling) at least once per week and you have sufficient English language skills to understand instructions from the researcher. 

What does it involve?
All participants who choose to enrol in this study will receive a femfit® device that provides live data on the person's ability to correctly contract their pelvic floor muscles. All participants will be offered five instructional sessions with the research physiotherapist over a 12 week period. These will either be in person or on telehealth. 

Each session will be 30 minutes in duration. Using the femfit® device, the research physiotherapist will teach participants their pelvic floor muscle training program. As a home exercise program, the participants will complete the pelvic floor muscle training program using the femfit® app and record their progress in an exercise diary. 

Participants will be asked to complete an online questionnaire to assess the frequency, severity, bother and impact of their urinary incontinence at the start and end of the 12 week intervention and after 12 months. They will also complete a questionnaire measuring their satisfaction of the program, perceived change in urinary incontinence and need for further treatment at the end of the 12 weeks. After 12 months, participants will also answer questions about duration of symptom improvement, utilisation of additional treatments and adherence to the home exercise program.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Miss Jess Lindstrom

Address

Monash University, Moorooduc Hwy, Frankston, Victoria 3199

Country

Australia

Phone

+61 3 9904 4509

Fax

[email protected]

Contact person for public queries

Name

Jess Lindstrom

Address

Monash University, Moorooduc Hwy, Frankston, Victoria 3199

Country

Australia

Phone

+61 3 9904 4509

Fax

[email protected]

Contact person for scientific queries

Name

Jess Lindstrom

Address

Monash University, Moorooduc Hwy, Frankston, Victoria 3199

Country

Australia

Phone

+61 3 9904 4509

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified participant and outcome data will be made available upon request for those completing relevant systematic reviews, as per ethical approval.

When will data be available (start and end dates)?

Immediately following publication, no end date.

Available to whom?

Researchers that request data for use in relevant systematic reviews.

Available for what types of analyses?

For use in systematic reviews.

How or where can data be obtained?

By contacting researchers directly - at the email [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Email
21183	Study protocol	[email protected]
21184	Ethical approval	[email protected]
21185	Statistical analysis plan	[email protected]
21186	Informed consent form	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically