Pelvic floor therapies after surgery for gynaecological cancer: a telehealth intervention trial

Pelvic floor muscle training (PFMT) + home exercise program + non-exercise components Pelvic floor muscle training (PFMT) intervention: o 'What' The intervention: 7 x 30 minute telehealth sessions over 12 weeks (e.g. at 0, 2, 4, 6, 8, 10 & 12 weeks). o 'Who' The provider: Physiotherapist with postgraduate qualification in pelvic floor physiotherapy o 'How' Group or individual: Individual telehealth-delivered instruction in PFMT, customised to each participant’s starting level of ability to do PFMT Supervision: Individually-supervised remotely via telehealth Each woman will also receive a Femfit® intravaginal pressure biofeedback device to help teach the correct contraction technique, to monitor pelvic floor muscle (PFM) strength gains during telehealth consultations and home practice, and to aid adherence to PFMT home exercise program via the Femfit® app which the participant will download to their phone. Adherence to exercise measures: Exercise diaries Motivation strategies: Behaviour change techniques (biofeedback, behaviour goal setting, action planning including implementation intentions, instruction on how to perform behaviour (PFM exercise), outcome goal setting, review of behaviour goals, problem solving, verbal persuasion to boost self-efficacy, self- monitoring, association with prompts or cues) Progression - decision when to progress: Every 4 weeks Detailed description of exercise session: Using real-time feedback from the Femfit biofeedback device and app, the Femfit strength building protocol will be used, as follows: 3 sets of 6 repetitions of a pelvic floor muscle contraction of 6 seconds instructed to be held at maximal voluntary contraction strength, with 6 seconds rest in between, then 3 sets of 6 repetitions of a rapid pelvic floor contraction (1 second hold, 1 second rest) instructed to be completed at maximal voluntary contraction strength, then 3 repetitions of a pelvic floor muscle endurance contractions instructed to be held at 50%-100% of maximal voluntary effort for 18 seconds, followed by 18 seconds rest, then 3 sets of coordination contractions with a rapid pelvic floor contraction and cough, instructed to be performed at the same time, 3 times in a row. Progression - type: Duration of muscle hold and number of repetitions; increasing anti-gravity positions Adherence to intervention measure: clinician record of participant attendance or non-attendance to intervention sessions and of the components of therapy completed within each session. + Home exercise program component: Exercises detailed in home exercise handout specifying position, time, dosage, effort, which can be done with and without the Femfit® intravaginal pressure biofeedback device. The exercise is a daily local muscle exercise of the pelvic floor muscles as per the 12-week strength building programme included in the Femfit mobile device app and is the same as the supervised exercise session that will be done with the physiotherapist via telehealth. Exercise sessions will take 8-18 minutes. Intensity of each contraction will be determined by self-perceived percentage of maximal voluntary contraction strength, with each contraction instructed to be done at 50-100% of maximal voluntary contraction strength. This will be done over the same 12 weeks as the weekly telehealth sessions. Adherence will be monitored by the exercise diary included in the Femfit app. +/- Non-exercise component: Participants who present with symptoms of PFD which require conservative therapies other than PFM exercise, as assessed by the clinician providing the intervention, will be provided with these education-based therapies at their first post-operative physiotherapy session, and continued alongside PFM exercise as required: For urinary urgency and frequency or urge urinary incontinence: bladder training including urinary urge suppression techniques, education on fluid intake modification including caffeine reduction if relevant, and education in good bladder and bowel habits. For faecal incontinence: bowel routine training, education on dietary fibre including psyllium supplementation, education on faecal urgency suppression techniques and education about defecation dynamics and toileting posture. These components will be provided with an additional 5-15 minutes at each telehealth session to address each component. Any time spent addressing these components will be recorded by the clinician providing the intervention.