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\begin{document}

\title{Postpartum pelvic organ prolapse and pelvic floor muscle training
Results from a randomized controlled trial of primiparous women}



\author[1]{Thorgerdur Sigurdardottir}%
\author[1]{Thora Steingrimsdottir}%
\author[1]{Reynir Geirsson}%
\author[2]{Thorhallur Halldorsson}%
\author[2]{Thor Aspelund}%
\author[3]{Kari Bo}%
\affil[1]{Landspitali University Hospital Department of Obstetrics and Gynecology}%
\affil[2]{University of Iceland School of Health Sciences}%
\affil[3]{Norwegian School of Sport Sciences Department of Sports Medicine}%


\vspace{-1em}



  
  \date{May 24, 2024}


\begingroup
\let\center\flushleft
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\selectlanguage{english}
\begin{abstract}
Objectives To study effects of physiotherapist-guided pelvic floor
muscle training on pelvic organ prolapse (POP) early postpartum period.
Design Assessor-blinded, randomized controlled trial. Setting
Physiotherapy Clinic, Reykjavik. Sample Eighty-four primiparous women
with a singleton delivery. Methods Participants were screened for
eligibility 6-13 weeks postpartum. Women randomized to the training
group conducted 12 weekly individual sessions with a physiotherapist,
starting on average 9 weeks after childbirth. Outcomes were assessed
after the last session (short-term) and at 12 months postpartum
(long-term). The control group received no instructions after the
initial assessment. Main outcome measures Self-evaluated POP symptoms by
the Australian Pelvic Floor Questionnaire. Results Forty-one and 43
women were randomized to the training and control groups, respectively.
At recruitment, 17 (42.5\%) of the training and 15 (37\%) of the control
group reported prolapse symptoms (p=0.6). Five (13\%) from the training
and 9 (21\%) controls were bothered by the symptoms (p=0.3). There was a
gradual decrease in the number of women with symptoms and no significant
short-term (p=0.08 at 6 months) or long-term (p=0.6 at 12 months)
differences between the groups regarding rates of women with POP
sympoms. No difference was between groups regarding bother in the short
(p=0.3) or longer term (p=0.4). Repeated measure analyses using Proc
Genmod in SAS did not indicate a significant effect of the intervention
over time, p\textgreater{}0.05. Conclusions There was an overall
decrease in postpartum symptoms of POP and bother during the first year.
Physiotherapist-lead pelvic floor muscle training did not change the
outcomes.%
\end{abstract}%



\sloppy


\textbf{Postpartum pelvic organ prolapse and pelvic floor muscle
training}

\textbf{Results from a randomized controlled trial of primiparous women}

Thorgerdur SIGURDARDOTTIR PhD\textsuperscript{1,2}, Thora
STEINGRIMSDOTTIR MD, PhD\textsuperscript{1,2}, Reynir T. GEIRSSON MD,
PhD, FRCOG \textsuperscript{1,2}, Thorhallur I. HALLDORSSON
PhD\textsuperscript{3}, Thor ASPELUND PhD\textsuperscript{1}, Kari B\selectlanguage{ngerman}Ø
PhD\textsuperscript{4,5}.

\textsuperscript{1}Faculty of Medicine, School of Health Sciences,
University of Iceland, Reykjavik,

\textsuperscript{2}Department of Obstetrics and Gynecology, Landspitali
University Hospital, Reykjavik, \textsuperscript{3}Faculty of Food
Sciences and Nutrition, School of Health Sciences, University of
Iceland, Reykjavik, Iceland, \textsuperscript{4}Department of Sports
Medicine, Norwegian School of Sports Sciences,
Oslo,\textsuperscript{5}Department of Obstetrics and Gynecology,
Akershus University Hospital, Lørenskog, Norway.

\textbf{Corresponding author:}

Thorgerdur Sigurdardottir

Department of Obstetrics and Gynecology

Landspitali University Hospital

Reykjavik, Iceland

Department of Medicine

School of Health Sciences

University of Iceland

Reykjavik, Iceland

Tel: +354 6929092

Email: th.sigurdardottir@gmail.com

\textbf{Running head:}

Postpartum pelvic floor muscle training for prolapse symptoms

\textbf{Word count:}

Abstract: 247

Main text: 2617



\emph{Objectives}

To study effects of physiotherapist-guided pelvic floor muscle training
on pelvic organ prolapse (POP) early postpartum period.

\emph{Design}

Assessor-blinded, randomized controlled trial.

\emph{Setting}

Physiotherapy Clinic, Reykjavik.

\emph{Sample}

Eighty-four primiparous women with a singleton delivery.

\emph{Methods}

Participants were screened for eligibility 6-13 weeks postpartum. Women
randomized to the training group conducted 12 weekly individual sessions
with a physiotherapist, starting on average 9 weeks after childbirth.
Outcomes were assessed after the last session (short-term) and at 12
months postpartum (long-term). The control group received no
instructions after the initial assessment.

\emph{Main outcome measures}

Self-evaluated POP symptoms by the Australian Pelvic Floor
Questionnaire.

\emph{Results}

Forty-one and 43 women were randomized to the training and control
groups, respectively. At recruitment, 17 (42.5\%) of the training and 15
(37\%) of the control group reported prolapse symptoms (p=0.6). Five
(13\%) from the training and 9 (21\%) controls were bothered by the
symptoms (p=0.3).

There was a gradual decrease in the number of women with symptoms and no
significant short-term (p=0.08 at 6 months) or long-term (p=0.6 at 12
months) differences between the groups regarding rates of women with POP
sympoms. No difference was between groups regarding bother in the short
(p=0.3) or longer term (p=0.4). Repeated measure analyses using Proc
Genmod in SAS did not indicate a significant effect of the intervention
over time, p\textgreater{}0.05.

\emph{Conclusions}

There was an overall decrease in postpartum symptoms of POP and bother
during the first year. Physiotherapist-lead pelvic floor muscle training
did not change the outcomes.

\textbf{Tweetable abstract (up to 110 letters)}

An RCT showed that 12 weeks of supervised early postpartum PFMT did not
influence POP symptoms up to 12 months postpartum.

\textbf{Funding:}

This study has received grants from following funds:

University of Iceland Research Fund, Public Health Fund, Icelandic
Directorate of Health, Icelandic Physiotherapy Association Science Fund,
Landspitali University Hospital Science Fund.

\textbf{Key words}

Pelvic floor muscle training, pelvic floor muscles, pelvic organ
prolapse, physiotherapy, postpartum, primiparity, quality of life.

\textbf{Abbreviations}

AI, anal incontinence; APFQ, Australian Pelvic Floor Questionnaire; CG,
control group;

CI, confidence interval; PFD, pelvic floor dysfunction; PFM, pelvic
floor muscles; PFMT, pelvic floor muscle training; POP, pelvic organ
prolapse; CS, cesarean section; RCT, randomized controlled trial; SD,
standard deviation; TG, training group; UI, urinary incontinence; VD,
vaginal delivery.

\textbf{Introduction}

Pelvic organ prolapse (POP) is a distressing and common symptom in the
female population and has been reported in up to 10\% of the adult
female population when based on a bulging sensation into the
vagina.\textsuperscript{1} However, the prevalence of anatomic POP is
higher; a population-based study which included pelvic examinations
showed a prevalence of 31\% among women aged
20-59.\textsuperscript{2}POP is defined as a loss of support for the
vaginal walls, the uterus, bladder, colon and rectum resulting in
partial or complete prolapse of the affected organs coming down or
through the vagina.\textsuperscript{3} The prevalence of POP in the
early postpartum period is sparsely investigated. According to Reimers
et al,\textsuperscript{4} anatomic POP stages \selectlanguage{english}[?]2 were found in 9\% of
primiparous women six weeks postpartum with no significant difference
between women after vaginal delivery (VD) or cesarean section (CS). In
another study evaluating anatomic POP in primiparous women at 5-22 weeks
postpartum stage 2 POP was noted in 35.5\% of the women, of whom 7.6\%
had this after CS vs. 43\% for VD .\textsuperscript{5} We recently
showed an overall prevalence of self-reported POP symptoms 6-10 weeks
after first childbirth of 29\%, thereof 33\% in the VD- and 12\% in the
CS groups.\textsuperscript{6} POP symptoms in the immediate postpartum
period have been found to be related to pre-labor maternal
characteristics, such as a larger levator hiatal area, a longer distance
from the urethral meatus to the anus and a more caudal position of the
anterior vaginal wall at mid-pregnancy.\textsuperscript{4} Later in
life, POP has also been associated with a low body mass index, higher
parity, higher birthweights, operative and instrumental VD, levator ani
trauma and constipation.\textsuperscript{7--10}

The International Consultation on Incontinence concluded that there is
1A level of evidence for pelvic floor muscle training (PFMT) to be
useful as first line treatment for POP stages I-III in the general
population.\textsuperscript{11} However, there is scant knowledge on the
effects of PFMT in the early postpartum period. In a systematic review
and meta-analysis outcomes with regard to postpartum POP symptoms have
been reported.\textsuperscript{12} The authors concluded that quality of
evidence was low for the primary outcome of POP symptoms, and that the
question of whether postpartum PFMT has a beneficial effect on POP
symptoms remains unanswered. The aim of this study was to evaluate the
effects of individualized, postpartum physiotherapist-guided PFMT on the
rate of symptomatic POP and perceived bother.

\textbf{Materials and methods}

\emph{Study design}

This was a secondary analysis of a parallel-group, assessor-blinded
randomized controlled trial (RCT) with the primary aim of examining the
effects of postpartum PFMT on the rate of postpartum urinary
incontinence (UI) and anal incontinence (AI) in primiparous
women.\textsuperscript{13} The trial was carried out at a Physiotherapy
Clinic in the Reykjavik Capital Area, from March 2016 to January 2018.
Baseline assessments and background data of participants were obtained
at recruitment 9 weeks postpartum (range 6-13 weeks). Short-term
outcomes were completed at the end of treatment at around 6 months
(range 5-7), and long-term outcomes were investigated at 12 months
(range 11-14) postpartum.

The study was approved by the Icelandic National Bioethics Committee
(Ref: VSN-13-189), the Icelandic Data Protection Authority (Ref:
2014030475TS/--) and registered at https://register.clinicaltrials.gov
(NCT02682212). The study was conducted according to the Helsinki
declaration on human experimentation. All participants provided a signed
informed consent. Delivery and maternal data were obtained from the
Icelandic Medical Birth Register.

\emph{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.\textsuperscript{6}Of all the women who answered the
questionnaire, 95 were invited to participate in an
RCT.\textsuperscript{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 \selectlanguage{english}[?]18 years, able to understand
Icelandic and to attend the treatment sessions. Women with a multiple
birth, a gestaional length of \textless{}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.\textsuperscript{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.\textsuperscript{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.

\emph{Outcome measures}

In the present study we aimed to examine the effects of PFMT on rates of
POP symptoms as well as bother from symptoms, as assessed by the
Australian Pelvic Floor Questionnaire\textsuperscript{17,18} (APFQ,
Icelandic translation). The questionnaire had previously been rigorously
translated and pre-tested,\textsuperscript{19} but not validated.

POP was evaluated by the questions ``Do you have a sensation of tissue
protrusion or a lump or bulging in your vagina?`` and ``Do you
experience vaginal pressure or heaviness or a dragging sensation?``
Women were considered to have no sympoms if the they answered \selectlanguage{english},,never``
to both questions. Answers of \selectlanguage{english},,occasionally``, \selectlanguage{english},,frequently`` and
\selectlanguage{english},,daily`` were considered signs of POP. Bother is a concept used in the
APFQ and can in general be defined as trouble, nuisance, worry or
something annoying. Bother was considered absent when the answer to the
question \selectlanguage{english},,How much does your prolapse problem bother you?`` was ``not at
all``. Answers of ``slightly, moderately and greatly`` were considered
as bother. According to this approach, data were analyzed as
categorical, 0 = no symptoms or no bother and 1 = signs of symptoms
and/or of bother.

\emph{Intervention}

The intervention entailed 12 sessions with a duration of 45-60 minutes
for each visit. The exercise period lasted on average 3.7 (range
2.6-6.7) months. The participants met weekly with a physiotherapist. If
they cancelled, a new appointment was given in order to accomplish 12
sessions.

The NeuroTrack Simplex(r) biofeedback device with electromyographic
vaginal sensors (Quintet, Norway) was used to facilitate the PFMT.
Treatment was customized to each woman's capacity within a protocol
encouraging 10 close to maximum contractions and 5 second holding
periods with a 10 second rest between each contraction. During the first
two appointments women were coached to do two exercise sets during every
visit with a rest in between and thereafter 3 x 10 contractions if
possible. The participants used the biofeedback device to aid progress
and to help with relaxation between each contraction. During visits 8-9,
the women were asked to add three fast contractions at the end of each
contraction and do so in the remaining sessions.\textsuperscript{20}

Women in the TG were asked to do home exercises of 10 close-to-maximum
PFM contractions, three sets/day and use the \selectlanguage{english},,knack`` (pre-contracting
the PFM before coughing and sneezing).\textsuperscript{21} They were
encouraged to adhere to the home training program and to register daily
exercises in a training diary. During each visit they were encouraged to
adhere to the home exercises.

The short-term evaluation was done within a week after the last training
session. Long-term assessment was one year after childbirth. At both
time-points women answered the APFQ. During the long-term appointment
participants also answered a questionnaire about PFMT adherence. The CG
women had no further follow-up after recruitment, which included general
instructions and assessment of PFM contractions, but they were not
discouraged from doing PFM exercises. The main assessor was blinded to
group allocation throughout the study.

\emph{Sample size calculation}

Sample size was estimated for the primary study on UI and
AI\textsuperscript{13} and was based on outcomes from a previous
study.\textsuperscript{20} No further power calculation regarding POP
symptoms was conducted for the present study.

\emph{Statistical analysis}

We used SPSS, version 24 (IBM, Armonk, NY, USA) for all statistical
analysis except for the repeated measure analyses by Proc Genmod which
was done in SAS version 9.2. Normally distributed continuous variables
are presented as means with standard deviations (SDs). Other
participants characteristics are reported as counts with percentages.
Rates of POP and bother were analyzed with chi-squared tests. The study
was analyzed by intention-to-treat. Additional per-protocol analysis was
done. Significance levels were set to 0.05.

\textbf{Results}

In all, 84 Caucasian women entered the study, 41 to the training group
and 43 controls, with the initial session occurring at a mean 9 weeks
postpartum (range 6-13 weeks). Baseline characteristics are shown in
Table 1. Four women (three from the TG) withdrew after the initial
evaluation (Figure 1). Characteristics and delivery outcomes did not
differ between participating and non-participating women except that
women who dropped out were slightly younger and had smaller babies. Five
women did not participate in any of the training sessions or did any
home PFMT but contributed to the main outcome measures. All 33/41 women
who attended the intervention completed all 12 sessions with the
physiotherapist. No adverse treatment-effects were reported.

\emph{Short-term outcome measures}

At recruitment 17/40 (42.5\%) and 15/41 (37\%) women in the TG and CG
respectively reported POP symptoms (p=0.6). Short-term (6 months
postpartum) and long-term (12 months postpartum) results of POP are
shown in Table 2.

There were no differences in POP rates between the groups measured at 6
months postpartum leaving 8/36 in the TG and 3/38 from the CG
symptomatic (p=0.08). There were no significant differences between
groups in the rates of women who were bothered by POP symptoms at
short-term with five TG women at both timepoints being bothered by POP,
but reduced from nine to one woman being bothered in the CG (p=0.08).

\emph{Long-term outcomes}

POP rates at 12 months after childbirth revealed no difference between
the groups, with 4/38 from the TG and 6/42 from the CG still symptomatic
(p=0.6). There were no differences regarding the rates of women bothered
by symptoms in the TG and CG respectively, leaving 1/37 and 3/42 in the
TG vs. CG bothered by POP symptoms (p=0.4).

Repeated measure analyses using Proc Genmod in SAS did not indicate a
significant effect of the intervention over time, p\textgreater{}0.05.
Analysis per-protocol did not change the outcomes.

\textbf{Discussion}

\emph{Main findings}

POP symptoms were overall reduced considerably in this group of
first-time mothers during the postpartum year, and the feelings of
bother were in general mild and not common. This is in line with the
results from a cohort study by Reimers et al (2016) which showed good
recovery of POP symptoms in primiparous women during the first year
postpartum.\textsuperscript{22}

Limited data from RCTs are available regarding the treatment effects of
PFMT for POP symptoms in the postpartum period despite the wide practice
of advising and providing such treatment. Bo et al (2015) did not find
improvements for POP symptoms when assessing the effect of a 4-month
group-lead PFMT at 6 months postpartum. However, that study included
women with diagnosed major levator ani tears which might have reduced
the odds for improvement.\textsuperscript{23} Yang et al (2013) found
significant differences in postpartum POP stages in favour of the two
training groups when measured at three months postpartum, where one
group included PFMT and the other involved PFMT combined with vaginal
electrical stimulation. The combination treatment was superior to PFMT
alone when compared to a control group.\textsuperscript{24} Both studies
had larger sample sizes than our study. A Chinese RCT with only the
abstract available in English disclosed positive results regarding
postpartum POP symptoms after PFMT with biofeedback combined with
electrical stimulation when measured 12 weeks
postpartum.\textsuperscript{25}

It is, however, difficult to evaluate the information given with regard
to how the treatment was conducted. Pelvic floor electrical stimulation
can provoke the muscles to contract as well as produce responses from
the central nervous system, i.e. increase the awareness of the muscle
contractions which could be important for women with a weak
PFM.\textsuperscript{26--28} However, use of electrical stimulation can
be questioned in the early postpartum period and when women are
breast-feeding. Low levels of estrogen and thinning of the vaginal
mucosa may make electrical stimulation painful. To date, the evidence
indicates that in the general female population electrical stimulation
of the pelvic floor muscles is better than no treatment, but the low
quality of published studies on the matter prevents conclusions when
comparing PFMT and electrical stimulation in treatment of
UI.\textsuperscript{27}

In our study, symptoms were in general benign and women may well have
had difficulties in distinguishing between never or occasionally (less
than once a week). Women in the TG might also have been more aware of
their symptoms during the intervention period as a result of the weekly
contacts with a women's health physiotherapist. Conversely, with no
contact to treatment providers, women in the CG could have considered
themselves as less symptomatic.

The steady decrease in the number of women with symptoms in the TG from
recruitment to one year after childbirth did, however, follow a measured
increase in PFM strength during the study period. As previously
reported, this improvement was significantly better in the
TG.\textsuperscript{13} The low number of symptomatic women at 6 months
postpartum in the CG seems to be an incongruity when looking at the
development of symptoms.

Adherence to PFM exercises at home which was encouraged by the
physiotherapists for the participants in the TG during the study period
has been published in an article reporting the effect of PFMT on
postpartum UI and AI.\textsuperscript{13} Adherence was in general poor,
especially during the latter half of the year which may have influenced
the results.

\emph{Strengths and limitations}

Strengths of the study were the randomized and assessor-blinded design,
concealed allocation, a supervised individually tailored program for
each participant aiming at treating the symptoms and high adherence to
the exercise sessions. Following the participants for one year should
also be considered a strength, as long term results are lacking in
published studies.\textsuperscript{12}

Limitations were the higher drop-out rate in the TG and the low number
of women reporting prolapse symptoms in both groups which may have
caused a type II error due to small sample size. Five women who were
randomized to the TG and contributed to the main outcomes did not
participate in the intervention, which also might have influenced the
results. The adherence to PFMT after cessation of the intervention is
also a limitation of the study.

\emph{Interpretation}

Our results confer with results from the few other RCTs evaluating
effect of PFMT in reduction of POP stage and symptoms in the postpartum
period.\textsuperscript{12} To date, all studies reported POP as
secondary analyses and not all women included in the studies had POP.
This may explain the negative results as well as the fact that the
studies were conducted in the early postpartum period. Studies indicate
that POP symptoms improve for the majority of primiparous women during
the first postpartum year.\textsuperscript{22,24} Therefore, to enhance
our knowledge on the influences of PFMT on postpartum POP symptoms, it
might be interesting to conduct an RCT later postpartum, e.g. one year
after birth for women who are still symptomatic.

\emph{Conclusions}

Postpartum symptoms of pelvic organ prolapse and bother decreased during
the first year for both controls and exercisers with no difference
between the PFMT and the control groups.

\textbf{Acknowledgements}

The authors thank Hulda Magnusdottir for her work in registering and
administering all clinical appointments for the participants of the
study, physiotherapists Fanney Magnusdottir and Gudrun Magnusdottir for
carrying out the training sessions. We express our gratitude for the
permission given by Dr. Kaven Baessler and co-authors to translate and
use the Australian Pelvic Floor Questionnaire.

\textbf{Disclosure of Interest:}

The authors report no conflict of interest.

\textbf{Contribution to Authorship:}

Physiotherapist Thorgerdur Sigurdardottir PhD contributed to the design,
execution, analysis and interpretation of the study.
Obstetricians/gynecologists Thora Steingrimsdottir MD, PhD and Reynir T.
Geirsson MD, PhD, FRCOG and Prof. Kari Bo PhD contributed to the design,
execution, analysis and interpretation of the study, while statisticians
Thorhallur Halldorsson PhD and Thor Aspelund PhD contributed to the
design and analysis of the material. All authors have contributed to the
writing of the manuscript.

\textbf{Clinical trial registration:}

The trial was registered 30\textsuperscript{th} of March 2015 at
https://register.clinicaltrials.gov (NCT02682212). Initial participant
enrolment was 16\textsuperscript{th} of March 2016 and reported
following CONSORT guidelines for RCTs.

\textbf{Funding:}

This study has received grants from following funds:

University of Iceland Research Fund, Public Health Fund, Icelandic
Directorate of Health, Icelandic Physiotherapy Association Science Fund,
Landspitali University Hospital Science Fund.

\textbf{Figure/table caption list}

\textbf{Figure 1}

CONSORT flow diagram of participants.

\textbf{Table 1}

Characteristics of included participants at recruitment and delivery
outcomes.

\textbf{Table 2}

Outcome measures at recruitment, short-term (6 months postpartum) and
long-term (12 months postpartum).

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