MJ Strauhal, PT, DPT, BCB-PMD
Pelvic
Physiotherapy Distance Journal Club
December 9, 2015
Primary Aim:
evaluate the effectiveness of a 4 month postpartum PFMT program on stage
of pelvic organ prolapse (POP), bladder neck position, and POP symptoms in
primiparous women following vaginal delivery
Background:
- POP is common and distressing
- Prevalence of POP differs when based on clinical
exam (>30%) versus symptom “bother” (5-10%)
- When symptomatic, POP causes discomfort, reduced
QOL, limitation of ADL’s
- Lifetime cumulative risk for POP surgery is
7-11%, reoperation is common, and
complications associated with mesh can be severe, warranting early
nonsurgical prevention and treatment
- 3-6 months postpartum occurrence rate of POP >
stage II is 18-56%
- 15-40% of primip wm have a mj. LA defectà when detected by US imaging, postpartum wm with
LA defect were 2x as likely to have POP stage II or > than those with
intact LA
- RCT’s have shown that PFMT is effective in
reducing POP symptoms and/or stage in middle-aged wm
- Systematic review concluded Level 1, grade A
evidence for PFMT in treatment of POP
- Assessor blind RCT found that PFMT improved PFM
strength and thickness, lifted the bladder neck (BN) and rectal ampulla,
narrowed the UGH and reduced mm length in wm with POP
Study Design (Materials and Methods):
- 2 armed parallel group RCT evaluating the effect
of PFMT on stage of POP, BN position, and POP symptoms in primips
stratified by LA defects
- Secondary analysis on the same population that
was studied by the same authors addressing prevention and treatment of UI
- 1st time pregnant women gestational
week 22 until 1 yr postpartum
- Inclusion- vaginal delivery to singleton after
> 32 weeks gestation and understands Scandinavian language
- Instrumented deliveries included (20% or
35/175)- 33 vacuum, 2 forceps
- Exclusion- cesarean deliveries, 3rd
and 4th degree perineal tears (routinely referred to PT!) ,
serious illness of mom or baby, IU fetal deaths/stillborns
- Power calculation was not done for POP, but
authors assumed a 30% prevalence rate of POP in postpartum period based on
calculations in same population UI study and previous studies
- Women were stratified on mj. LA defects as
assessed at 6 weeks postpartum (pretest) by US imaging during maximum PFM
contraction as described by Dietz- a method that showed good intra- and
interrater reliability shortly after childbirth
- Participants were randomized in blocks of 10 to
either PFMT or control with usual care
- Outcomes were measured at 6 weeks (pre-test) and
6 months (posttest) postpartum
- POP stage measured by POPQ during strain in 45
degrees lithotomy, rigorously standardized and measured by 1 of 2 GYN’s
- No POP = stages 0 and I, POP = stages II or
>
- BN position assessed by 2 GYN’s using US imaging
per Schaer (1995) in the sagittal plane
- Symptoms of POP (sensation of bulging) assessed
by ICIQ-vag (good reliability, validity, sensitivity to change) but of
the 14 questions, only the 2 on perceived bulging were asked
5. Are you aware of a lump or bulge coming down in your vagina?
never 0
occasionally 1
sometimes 2
most of the time 3
all of the time 4
6. Do you feel a lump or bulge come out of your vagina, so that you can
feel it on the outside or see it on the outside?
never 0
occasionally 1
sometimes 2
most of the time 3
all of the time 4
·
Blinding- GYN’s and PT’s were blinded to symptoms
of POP and group allocation
·
PFM
o
2 trained PT’s taught and assessed PFM contraction
by with both perineal observation and vaginal palpation
o
PFM strength was measured using a pressure
transducer connected to a balloon placed 3.5 cm from the vaginal introitus- the
method has shown good reliability and only contractions with simultaneous
visible inward mvt of the catheter/perineum were considered correct
·
Intervention
o
At the delivery ward, all wm were recommended PFMT
in written form
o
At pre-test (6 weeks postpartum), assessment of PFM
and instruction in correct contraction was done for all participants before
randomization
o
Intervention group (PFMT group)
§ Attended
weekly PFMT class led by PT x 4 months starting at 6-8 weeks postpartum and
attendance was documented
§ Were asked
to perform 3 sets of 8-12 close to max PFM contractions per day and reported adherence
using a training diary
o
Control group
§ No further
supervision or f/u during the intervention period, but were not discouraged
from performing PFMT on their own
Statistical
Analysis and Results
- 175 primips were
randomized into the study, mean age 29.8 years, mean BMI 25.7 kg/m2
- See Table 1 and
Flowchart; no statistical
significant difference between the groups in gestational age, length of 2nd
stage labor, infant birthweight and head circumference, or # with
instrumented delivery
- Intervention group
- 2 wm never met for
PFMT, 10 wm lost to f/u = 12 total lost to f/u
- 87 wm allocated to
this group, 75 wm analyzed
- At 6 months
postpartum 2 from this group who at 6 weeks postpartum were unable to
correctly contract the PFM had learned this at 6 months postpartum
- 96% of this group
adhered to >80% of group and home PFMT
- Control group
- 3 wm lost to f/u
- 88 wm allocated to
this group, 85 analyzed
- At 6 months
postpartum 1 from this group who at 6 weeks postpartum was unable to
correctly contract the PFM had learned this at 6 months postpartum
(still leaves 4 of 7 who did not perform PFM contraction correctly
unaccounted for)
- 16.5% reported to
have done PFMT >3x/week
- At 6 months postpartum
(posttest)
- Statistically
significant difference in change of PFM strength in favor of the PFMT
group (they did not report this data in the article)
- No significant
difference in primary outcomes
- Table 2 POPQ stage-
no difference between groups or in change of POP stage between groups
- Table 4 shows that
there is no significant change from pre to posttest between groups in
relative risk (RR) of being diagnosed with POPQ stage II (95% CI)
- Table 3 BN per
transperineal US (and point values for POPQ)
- Table 5 ICIQ-vag
(sensation of bulging)
- # wm with symptoms
of bulging inside the vagina was significantly higher in the control
group both at pre and posttest
Discussion
- An intensive PFMT program did not improve POP, BN position or
symptoms of bulge in this population of primips after vaginal delivery;
nor did outcomes improve in subgroup of wm with mj. LA defects
- Studies on
middle-aged wm with POP have shown improvement in POPQ stage I and in
symptoms bother after PFMT
- Braekken et al,
showed a change in BN and rectal ampulla position after PFMT
- Some women in this
study experienced symptom bother and POP at 6 months but not 6 weeks
postpartum
- The authors
hypothesized that this was due to a return to optimal physical activity
and participation in sports and fitness activities; general physical
activity was the same for both groups between the pre and posttest period
- They expected the
supervised PFMT to counteract this in the intervention group
- Remission of POP in
the postpartum period
- Little knowledge in
the literature- there is need for cohort and RCT postpartum studies
- Elenskaia et al,
found worsening POP stage and symptoms from pregnancy at 14 weeks and 1
year postpartum
- Chen et al, found
return to “normal” is not complete at 6 weeks postpartum and continues to
1 year postpartum
- Strengths of the study
- RCT design, blinding
of assessors, use of supervised training following recommendations for
strength training (ACSM), high adherence, use of valid and reliable
outcomes
- # of wm with stage I
and II POP and symptoms in this study reflect other cohort studies and
appear representative of this population
- Limitations of the
study
- Some loss to f/u,
small sample size in some of the comparisons
- ICIQ-vag was not
validated in the postpartum population (and they only used 2 of the
questions!)
- Other comments
- Exercise training may
be ineffectual due to insufficient dosage or low adherence
- This study used a
training protocol following recommendations for strength training which
has shown effect in postpartum wm with UI and middle-aged wm with POP
- Group training was
chosen in this study because the same protocol was effective in
prevention and treatment of UI in pregnancy and postpartum
- Individual training
may be required to prevent or treat POP
- Those allocated to
the control group may have wished to be in the PFMT group and therefore
exercised more than prescribed for their group (ie, no supervision, f/u,
or group PFMT); 16.5% of this group exercised >3x/week
- Change in PFM
strength between the PFMT group and the control group was statistically
significant but only the mean 3.6 cm H2O (no report of this
data in the article except here)
- Is
this clinically relevant?
- Did
not produce any change in POPQ or symptom report
- Braekken et al,
reported BN elevation of 4.2 mm (95% CI) following PFMT with no change in
their control group
- In this study, both
groups demonstrated a mean of 2.0 mm change in BN elevation (Table 3
reports results in cm) which the authors report as nonsignificant
- Was the present
program less effective? Or, did
the postpartum hormonal status of the wm negatively influence
connective tissue and muscle function (the authors did not report data
on breastfeeding status).
- There were no wm in
this study that had POPQ stage III.
Would the program have been more effective in a group with more
severe POP?
- Future studies: more RCT’s that include supervised
individual training rather than, or in addition to, group training
- High prevalence of POP
(and impact on QOL) warrant high priority to early prevention and
treatment
Journal
Club Discussion (in addition to questions proposed in the body of this outline)
- What are the
implications for clinical practice from this study?
- Will the results of
this study change your current practice pattern with wm who experience
POP?
- Should PT’s be seeing
only wm who report “bother” from POP or any wm who has POP from
examination?
- Any comments of the study design, stats, and conclusions made by the authors?
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