Participants and randomization
Through 2016 and 2017, primiparous women with one live newborn were
approached before discharge from the maternity ward of the Landspitali
University Hospital in Reykjavik. Women who approved were sent an
electronic questionnaire through e-mail about their experiences of
pelvic floor dysfunction (PFD) 6-10 weeks postpartum.6Of all the women who answered the questionnaire, 95 were invited to
participate in an RCT.13 Eligibility criteria were
established for that study, i.e. the presence of self-reported
postpartum symptoms of UI. The women had to be generally healthy, aged
≥18 years, able to understand Icelandic and to attend the treatment
sessions. Women with a multiple birth, a gestaional length of
<32 weeks, a stillbirth or an unwell newborn or those who
otherwise had conditions that could interfere with their ability to
participate were excluded (inability to contract their pelvic floor
muscles (PFM), neurological conditions, previous urogynecological and/or
bowel surgery or cognitive disorders). The main outcome assessor (T.S.)
evaluated participants initially and before randomization at an
outpatient physiotherapy clinic.
At baseline, all the women received instructions about how to correctly
contract their PFM, which was confirmed with an observation and vaginal
palpation of PFM contractions defined as an inward movement of the
perineum and a squeeze around the pelvic
openings.14–16 Subsequently, measurements of PFM
variables were done with a vaginal manometer, the Myomed 932 (Enraf
Nonius, Netherlands). The results have been reported
elsewhere.13 Following this clinical assessment, the
clinics´ secretary allocated participants to either a training group
(TG) or a control group (CG) using conceiled random sequence numbers
from an on-line generator
(https://stattrek.com/statistics/random-number-generator.aspx). The
Microsoft Excel document containing the randomization code was locked
with a password and only accessible to the secretary. She was
responsible for booking participants for the short-term and long-term
appointments.