None listed
Conditions
Brief summary
This study is aiming to determine the feasibility of delivering pelvic floor muscle training using telehealth to treat urinary incontinence in women with breast cancer in Australia. Who is it for? You may be eligible for this study if you are aged 18-80, you have been diagnosed with breast cancer (stages I-IV) and you are currently experiencing stress urinary incontinence (urinary leakage when you cough or sneeze). Study details 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 8 instructional sessions with the research physiotherapist via videoconference (e.g. Zoom platform) over a 12 week period. Each session will be 30 mins in duration. Using the femfit® device, the research physiotherapist will then teach the pelvic floor muscle training program. As a home exercise program, the participant will complete the pelvic floor muscle training program using the femfit® app and record their progress on an exercise diary. Participants will be asked to complete an online questionnaire to assess the frequency, severity and impact of their urinary incontinence at the start and end of the 12 week intervention. They will also complete a questionnaire measuring their satisfaction of the program and perceived change in urinary incontinence at the end of the 12 weeks.
Interventions
What: The intervention is a 12-week pelvic floor muscle training program using a biofeedback device called the femfit®. The femfit® is a self-monitoring device which is inserted intravaginally and measures the intravaginal squeeze pressure during pelvic floor muscle contractions. Participants who are eligible and consent to the study will be provided with a femfit® via post. Participants must have access to a device with internet access and ZoomTM to engage in this program for video conferencing
What: The intervention is a 12-week pelvic floor muscle training program using a biofeedback device called the femfit®. The femfit® is a self-monitoring device which is inserted intravaginally and measures the intravaginal squeeze pressure during pelvic floor muscle contractions. Participants who are eligible and consent to the study will be provided with a femfit® via post. Participants must have access to a device with internet access and ZoomTM to engage in this program for video conferencing purposes and to download the femfit® application on to their mobile phone. Each telehealth session will be approximately 30mins in duration. In the first telehealth session, participants will learn how to contract their pelvic floor muscles, how to complete their home exercise program and how to use the femfit® to monitor this. The pressure readings on the femfit® display will be used to indicate when the participant is able to correctly contract the pelvic floor muscles. The researcher will then teach the participant her starting level of the pelvic floor muscle training program. The purpose of pelvic floor muscle training is to strengthen the pelvic floor muscle and increase the urethral closure pressure to prevent urinary leakage. All seven follow-up sessions will be conducted via a web-based platform such as ZoomTM. Audio and video conferencing sessions used to deliver the remote instruction will not be recorded. No specific exercise equipment is required other than the femfit® device and phone app. Who: The program will be conducted by the Principal Investigator, a registered physiotherapist. How: Participants will receive eight supervised, individual pelvic floor muscle training sessions over a period of 12 weeks. Exercises will be prescribed according to each woman’s starting level of PFM contraction ability (length of hold, number of repetitions) and progressed up to the optimal target dosage for PFM strength training: eight to twelve repetitions of pelvic floor muscle contractions, held for eight-seconds, two - three sets per day in the prescribed position. Further progression of exercises may include increasing the load of the exercise by progressing from across-gravity (lying) to against-gravity (sit or stand) positions. The home exercise program will take 8-16mins to complete everyday. Strategies to engage participants with the uptake of the exercise program will include exploring their barriers and enablers to pelvic floor muscle training in the first session, monitoring adherence to the program using an exercise diary and scheduling follow-up sessions. Where: The exercise program will be delivered online via ZoomTM.
Sponsors
The University of Melbourne
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 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: • Women who have been diagnosed with a histologically confirmed breast tumour (stages I-IV). • Women who currently experience stress urinary incontinence (urinary leakage when they cough or sneeze). • Women between 18-80 years of age. • Women who have sufficient English language skills to understand instructions from the researcher.
Exclusion criteria
Exclusion criteria: • Women who have neurological disorders or have severe physical/psychiatric impairments.
Outcome results
None listed