Long term effects of multidisciplinary assessment and pre-partum Pelvic Floor Muscle Group Treatment in adult gravid women with stress urinary incontinence compared to care-as-usual: a randomized controlled trial

1 in 3 women will be affected by urinary incontinence (UI) during her life,
evoking substantial individual morbidity, loss in quality
of life (QoL)and socio-economic costs (1,2). The first pregnancy and childbirth
are the most important causal and provocative
factors for UI during lifetime (1).
UI impacts not only on the physiological but also on the psychological realms
of a person*s life (3). The condition can have
significant impact on her individual self-esteem and general wellbeing. It
means that on top of losing bladder control, having to
wear incontinence pads make young peri partum patients often crack their
individuality and self-confidence (3). Studies have
found that up to 50% UI sufferers will often avoid intimacy with their partners
(4). Stress UI is UI in relation to physical exertion
(5). Prevalence is 41% during pregnancy and up to 38% at 2-3 months after
delivery (1). If SUI during pregnancy, 42% > risk UI
in next 12 years (1). Stress UI can prevent people from participating in active
pursuits such as sports because of anxiety
regarding potential leakages. This tends to have knock-on impacts in terms of
obesity and hence exacerbating UI so that this
situation is self-perpetuating. All of these issues contribute to the enormous
QoL effects on sufferers (1,3).
Despite all this, 3/4 of new mums say they have never sought help from a health
care professional about their condition (6).
56% of women say they fell "embarrassed". Moreover, standard Dutch peri partum
care hardly pays any attention to UI, while,at
least on the short run, PFMT strongly reduces UI in advanced pregnancy and
early post partum (1). PFMT improves generic
QoL substantially > than control group at 3 months post partum (RR 7.2,95% CI
2.4-12.0)(1). Persistent pre-partum UI is
accessible by PFMT, but may be initiated too late. One of the reasons may be
that obstetricians and gynecologists are not (yet)
convinced of persisting long-term results of PFMT (1). Another is that
pre-partum women are not (yet)familiar with potential
solutions for their UI problem (6). As only a minority of pregnant women are
actively aware of the risk of UI (6)the Pelvic care
Center Maastricht (PcCM) designed motherfit, which is more than only PFMT. It
is a multidisciplinary strategy to treat women
with UI and make them aware peri partum of PFM importance as requirement for a
healthy lifestyle. The motherfit concept
focuses also on integrated self-management long term. Our health-care system to
support and increase adherence and durable
motivation for the holistic training program will enable pregnant and post
partum women (and individuals of other age groups) to
become co-managers of their health and wellbeing with the help of ICT, tools
and personalised services. Public and individual
awareness about the impact of pregnancy and vaginal delivery, their
pathophysiological consequences on the pelvic floor,
leading to UI and the possibilities to treat this health problem are starting
points of the motherfit strategy. Adequate patient
information and education and supervised, intensive PFMGT in the clinic will be
followed by and the base of a home
maintenance, personalized, self-management program.
In order to support maintenance of the home training program and lifestyle
advices we will introduce a health-care
system integrating a mobile App advising the user with accessible and
functional training plans, instructive videos and
relevant information, tips and lifestyle advices.
The tips and lifestyle advices will be in line with and support the midwife's
information and education. Midwives promote a
healthy lifestyle with information on adequate gestational weight gain, healthy
diet, mental wellbeing and avoiding negative
behaviours such as smoking and alcohol. Information on UI and how to prevent or
treat this can be an integrative part of health
education during the perinatal period aiming to support women in the
self-management of their own health. Clinical validation of
our health-care system as a home self-management device benefits the peri
partum UI patient and clinical practice. This
health-care system aims to stimulate the home maintenance training program,
increasing adherence and compliance with
PFMT. This strategy guides women through this extensive healing process and
makes PFMT part of a healthy lifestyle. This
concept is a major advantage in returning patients a sense of self again.
The App software integrates the training routine by visually translating the
program into accessible and attractive short videos.
The motherfit home self-training is based on the motherfit protocol involving
the high intensity, supervised program, described
before.

Objectives.
The primary aims of this multicenter randomized clinical trial (RCT) are
threefold
1. to investigate whether a structured assessment and treatment program of
intensive, supervised pre-partum pelvic floor muscle group training (PFMGT)
including its home maintenance reduces 18 months post partum UI severity
(frequency, amount, impact) in adult gravid women with stress urinary
incontinence;
2. to study in adult gravid women with stress urinary incontinence the effect
of treatment with PFMGT on UI severity (frequency,
amount, impact) comparing baseline (12-20 (+max 4) weeks gestation) with end
treatment (34 weeks gestation), and with 6 weeks and 6 months post partum
(study I motherfit pre-partum);
3.whether intensive supervised pre-partum pelvic floor muscle group treatment
(PFMGT) is cost-effective in adult gravid women with stress urinary
incontinence.
Participant characteristics and specific aspects of obstetric history and PF
function will be measured and used in the analyses
as possible predictors/confounders of a successful outcome on UI after PFMGT
pre-partum.

-DESIGN
The design is a randomized controlled trial (RCT). At 12 weeks adult gravid
women will be randomized to PFMGT or
CAU. Outcome measurement of (cost-)effects of PFMGT pre-partum compared to CAU.
The primary endpoint is 18 months. Data will be analysed by the
intention-to-treat procedure. This is a multicenter study with
participation of Maastricht University Medical Center (MUMC), Zuyderland MC,
Heerlen/Sittard, Laurentius hospital, Roermond,
Maxima MC, Eindhoven and surrounding midwife/GP/PPT practices.
Except for Maxima MC all obstetric centers are part of the Obstetric Consortium
Limburg, a first, second and third line obstetric
midwifery maternity care collaboration.
Feasibility of recruitment is high since in the region of Maastricht, Heerlen,
Sittard, Roermond and Eindhoven/Veldhoven:
- potentially 3300 vaginal deliveries of adult gravid women take place per year
- the 5 hospitals and midwifery practices in these areas already have a
cooperation in other obstetric and urogynecological
research projects and finally
- sufficient PPTs and ZwangerFit teachers are available to provide the training
in all areas.

-INTERVENTION DURING PREGNANCY
At 12 weeks gestation participants receive UI counselling by their
midwife/obstetrician/gynaecologist. A short
assessment of a correct contraction of PFMs by observation and vaginal
palpation of closing the vagina, in-and forward
movement of the perineum during contraction will be performed (26).
Women in de motherfit groep (PFMGT)not aware or not able to contract or relax
their PFMs correctly will be referred to the PPT for individual instruction on
PF anatomy and how to contract the PFMs correctly.
All women allocated to motherfit will receive a specially designed written or
digital instruction booklet on pre- and post-partum
PFM Group Training.
Next, all women, those who are able and those who are able after instruction by
the PPT to contract their PFMs, are referred to
8 intensive pre-partum group training sessions. PFMT includes instructions on
PF anatomy and how to contract, relax and train
the PFMs correctly and is combined with general fitness exercises. The PFMGT
starts from 20 weeks gestation and is
supervised by registered motherfit PT trainers. All women will receive via the
mApp or webApp an individual PFM home training
program and general advices on physical activity considering the intensity and
type of physical activity appropriate for pregnant
women for lifelong cure and prevention of UI and chronic diseases, and evidence
based lifestyle advices both verbally and
written addressing constipation, alcohol use, smoking, obesitas, physical
activity, etc) (12,13,14).
Performance of and adherence to PFMT will be reinforced by regularly sending
*push* notifications on the mApp or webApp, as
forgetting is the most important cause of inadequate adherence. Performance of
and adherence to PFMT will also be recorded
in women*s personal treatment diary. The diary will be available for the
motherfit group trainers and used to discuss women*s
motivation to incorporate adequate PFMT and use of PFM in their daily
activities (8,9).


-USUAL CARE/COMPARISON (CAU)
Participating midwifes/gynecologists/general practitioner give their normal
advices and pregnant women make their own choices as usual whether or not to
take part in any kind of pregnancy related pre- or post partum course. UI
women will receive CAU by their midwife/gynecologist/general practitioner.

Based on the nature of the assessments and intervention no risks or adverse
events are expected. Patients will have to fill out extra questionnaires and
personal training diaries which is considered a burden of minor importance.
There will be 5 outcome measurements including also at baseline one time
digital vaginal palpation on behalf of the pelvic floor muscle functional
assessment.
Patient will receive extensive information about their urinary incontinence
problem and what can be done to solve the problem. Extra time investment for
participation is limited.
Because we want to investigate adult gravid women with stress urinary
incontinence women can only be recruited from this population (group
relatedness)