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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000196549
Enrollment
26
Registered
2024-02-29
Start date
2024-06-03
Completion date
2025-09-25
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 partic

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.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 23, 2026