Serious game-enhanced biofeedback supported self-management versus standardized pelvic physiotherapy in women with mild to moderate stress urinary incontinence - A multinational, non-blinded randomized controlled trial

Urinary incontinence is a common problem with a prevalence ranging from 25.0%
(EPINCONT study) 1 to 51.1%2, and can be divided into three different types:
stress urinary incontinence (SUI, involuntary leakage on effort or exertion,
sneezing or coughing), urge urinary incontinence (UUI, involuntary leakage
accompanied by or immediately preceded by urgency) and mixed urinary
incontinence (MUI, involuntary leakage associated with urgency and also
exertion, effort, sneezing or coughing). One study, conducted in several
European countries, showed a predominance of MUI (42%), followed by SUI (38%)
and UUI (18%)3. The prevalence of urinary incontinence is known to reach a
peak around midlife (50-54 years), followed by a slight decrease and
stabilization around 65 years. After this stabilization the prevalence
encounters a steady rise1. Stress urinary incontinence in particular can lead
to women stopping to participate in physical exercises and social activities,
negatively affecting her confidence, self-perception and overall quality of
life.

There a several treatments for SUI, ranging from conservative treatments
(lifestyle interventions or pelvic floor muscle therapy) to surgery
(midurethral sling surgery). In a systematic review, pelvic floor muscle
therapy (PFMT) has proven to be a reliable primary conservative therapy in
stress urinary incontinence, especially in patients with a mild severity.
However, this review was based on articles with a generally short follow-up
duration4.

A recent randomized controlled trial has shown that women with
moderate-to-severe stress urinary incontinence have significantly better
subjective and objective outcomes at 12 months after midurethral sling surgery
than after pelvic floor muscle therapy. Furthermore, a high crossover rate
(49.0%) from PFMT to sling surgery was reported5.

The main problem of PFMT is that women do not adhere to the intervention and
stop performing their exercises. It has been proven that adding feedback to
physiotherapy improves the outcome6 and it seems that the role of the
physiotherapist is more to motivate and provide feedback, rather than
controlling the exercise as such. Requiring a physiotherapist makes the
intervention relatively expensive. In addition, PFMT is not accessible
everywhere in the world. In less populated areas, patients may have to travel
far to find a physiotherapist. Because of these flaws of the intervention,
investigators have searched for innovative ways to make pelvic floor muscle
exercises accessible to more patients.

The WOMEN-UP consortium has developed an intervention combining biofeedback and
motivating tools in a self-support ICT-system in order to reduce visits to the
physiotherapists, thus making treatment of stress urinary incontinence more
accessible. This self-support system consists of a vaginal and abdominal
biofeedback device (based on improvements of existing vaginal biofeedback
devices), an application for smartphone/tablet containing serious games and an
online platform on which the patient can upload her training results and
interact with her health care provider. It is hypothesized that the
self-support treatment via a decision support system and a secure remote
medical supervision is not inferior compared to PFMT with conventional
biofeedback supervised by a therapist in clinical setting.

The objective is to compare the intervention to standardized care PFMT in terms
of clinical, economic and satisfaction outcomes.

A secondary objective is to develop a prediction model to identify suitable
patients who will benefit the most from the intervention.

The study will be a multicenter, multinational, non-blinded, randomized
controlled trial

Holistic self-support system including:
1. Pelvic floor muscle training
2. Portable vaginal biofeedback device
3. Application for smartphone / tablet including serious games, intended to
facilitate training
4. An online platform intended to stimulate patients* adherence, check
progress, monitor adverse events and interact with her therapist.

During the trial patients will be asked to complete disease specific and
generic QOL questionnaires at four different timepoints. They undergo a pelvic
examination at 4 months after randomization which would not happen outside of
study conditions.

The only risk involved with the intervention is overtraining, leading to
complaints of vaginal pain during exercises or during coitus. Overtraining will
be noticed by the health care professional either by the answers on the short
questions after each exercise (self-support system) or by mention of the
patient during the weekly visit to the health care professional (standardized
PFMT group). If overtraining is noticed, the health care professional will
temporarily halt the training schedule for a period of at least a week. After
one week, training can recommence if the complaints have subsided.

Other risks are negligible