This trial is looking at the effectiveness of pelvic floor muscle training using a vaginal probe. The main outcome of this study is an improvement in urinary symptoms and patient satisfaction after 8 weeks. This trial is taking place in Alabama, California, Illinois, Massachusetts, Ohio and Oklahoma, USA.
Stress incontinence is urine leakage when there is pressure on the bladder. It is often observed when a patient coughs, sneezes or exercises. It happens as a result of weak muscles around the bladder that help hold urine in. It can be treated by pelvic floor exercises, drug therapy, pessaries (to support the walls of the bladder) or nerve stimulation. Surgery can also be an option when these treatments do not work.
Pelvic floor muscle training can be assisted with technology, such as vaginal probes. Leva digital pelvic health system involves inserting a vaginal probe and using a smartphone app for feedback on how exercises are performed. Many women prefer pelvic floor muscle training because it is less invasive than surgery and less tedious than medications or pessaries. But many women find it hard to know if they are carrying out the exercise correctly. The leva digital pelvic health system aims to help women learn when they are carrying out the exercises correctly.
Who are they looking for?
225 patients are needed for this study. To be included in this study, patients have SUI symptoms for 3 months or longer. Patients should be willing to stop any other SUI treatments during the first 8 weeks of the study.
Patients cannot have stage 3-4 pelvic organ prolapse (the pelvic organs such as bladder or rectum have fallen into the vagina). Patients cannot be unable to walk. They cannot be currently pregnant or less than 12 months after giving birth. Patients cannot have had failed SUI surgery within the last 3 months. Patients cannot have taken part in a pelvic floor muscle training plan within the last 12 months. Patients cannot be currently taking, or have taken in the last 2 months, urinary incontinence medication and cannot have had an artificial sphincter surgery.
How will it work
Patients will be randomly assigned to one of two groups. Group 1 will use the leva digital pelvic health system while they do pelvic floor muscle training for 2.5 minutes each day. Group 2 will perform kegel exercises 3 times a day. Patients will perform the exercises for 8 weeks. After 8 weeks patients will fill out questionnaires on their satisfaction with the treatment and on urinary symptoms. Patients will also fill out a 3-day urination diary. After 8 weeks patients can choose to remain on the treatments or to try another treatment. Group 1 patients will be randomly assigned to receive reminders to do the pelvic floor muscle training for 1 year or to not receive any reminders.
The main outcome is an improvement in urinary symptoms.