Ann
Dunbar PT, DPT, MS, WCS
September
10, 2014
Introduction:
- Pelvic organ prolapse (P)to
some degree is found on examination in 40% of women over 50
- Women with prolapse may present
with bladder, vaginal, bowel, abdominal, back and sexual sx affecting
daily living and QOL
- Conservative intervention
offered for women who are not candidates for surgery or who have P low in
severity; Interventions could include physical, mechanical, and lifestyle
interventions as well as care offered by women’s health PTs
- Physiotherapists (PTs) provide
pelvic floor muscle training (PFMT) aimed at improving strength,
endurance, and coordination of PFMs
- Additional research needed to determine medium and long term effectiveness of PFMT as well as cost-effectiveness
Primary Aim: To assess whether (1) One-on-one PFMT would reduce sx of P as well
as the need for further treatment.
(2) One-to-one PFMT would be cost
effective compared with patient education handout on P lifestyle advice.
Study Design: RCT
Methods:
Facilities: Mixture of
university teaching and general hospitals all offering similar PT services in UK
Eligible
subjects:
any woman of any age with Stage I, II, or III P confirmed by GYN exam including
POP-Q and where P sx were her primary complaint.
Exclusion
criteria:
Previous rx for P; pregnancy; less than 6 mo postpartum; unable to comply with
interventions. Women who needed rx for vaginal atrophy became eligible after
completing course of local estrogen.
Randomization: Subjects randomly
assigned to: (1) Individualized PFMT or
(2)Prolapse lifestyle brochure w/o PFM ex; subjects randomized to balance group
sizes for prognostic factors including: Stage of prolapse, desire for surgery,
and location of center. Other measures done for control are listed.
Procedures: PFMT
group invited to attend 5 sessions over 16 weeks (wks 0,2,6,11,16),
one-on-one with women’s health PT. First
appt included anatomy and function of PFM, education on types of prolapse with
model of pelvis and diagrams. Internal PFM assessment done w/ PERFECT Scheme.
Home program prescribed was based on results of assessment with goal of 10s
holds for 10 reps and 50 quick contractions 3x/day. Women also taught ‘The Knack.’ They recorded exercises done in diary. Prolpase education group
received brochure providing information on weight low, constipation, avoidance
of heavy lifting, coughing, and high-impact exercise sent by mail. Women in this group attended appt w/ GYN at 6
mo and at that time could request referral for further rx.
Outcomes: Questionnaires
mailed at baseline, 6 mo and 12 mo after trial entry. Primary Outcome: POP-SS measuring P sx at 12
mo. Secondary Outcomes (see article for
specific tools used): (1) Perceived
change in P since start of study; (2) QOL; (3) Number of days with P sx in
previous 4 weeks; (4) Uptake of further P treatment; (5) Severity of
incontinence; (6) Bowel sx; (7) General
health.
Adherence: Tracked by
attendance, daily exercise record and PT’s records about adherence to
prescribed exercise
Gynecologists:
used POP-Q on all women upon entry to study and at 6 mo review. Describes POP-Q
training for MDs.
Statistical
Analysis: Analylsis was by intention-to-treat
analysis. See article for details.
Results:
Subjects:
447 randomized to intervention group (225) or control group (n=222). Response
rate for Questionnaires at 6 months 365 (82% of women) and 12 months 295
(66%). Attendance at 6 mo review was 365
(82%). Non-attenders at 12 mo were significantly younger and had higher BMI
than did responders.
·
Table
1 Baseline Highlights: Mean age 56.8 (SD 11.5). Median no. births per woman was
2 (range 0 to 7). Women were overweight
(mean BMI 27 SD 5.1) Most common P defect was combined anterior, posterior, and
upper; Median duration of sx 12 mo.; Clinical and demographic factors at
baseline were similar between groups
·
Rx
group of women reported greater improvement in sx at both 6 and 12 mo.; Most
commonly reported sx was ‘feeling of something coming down’ which continued at
6 and 12 mo.
·
Adjusting
for testing center, POP-Q stage and motivation for surgery, women in rx group
had greater odds of reporting low-severity of P at 6 months than control group though not
significant
·
Significantly
more women in control group received additional rx (includes surgery, pessary,
PT, estrogen/drugs) after 6 months (50% in control vs. 24% in rx). Of those, 2
women in the rx group had additional PT referral whereas 38 in control group
requested PT
Discussion/Comments
- Researchers state this study
demonstrates greater reduction in P sx in women participating in
individualized PFMT compared to control.
In addition, they report the presence of ‘residual need’ for
supplementary treatments in the control group after 6 months, further
supporting the study results.
- Rx group also reported a
decreased prevalence in sx related to P, bowel, bladder and sexuality with
a better QOL at 6 mo.
- Rx group also more likely to
report P was ‘better’ at both 6 and 12 mo however improvements in measures
for P stage were not significantly different between groups.
- Authors state that
intention-to-treat rx effect estimate could be an understatement because
of number of women in control group who chose to do PFMT as well as lack
of use of other non-training interventions.
- At 12 mo, women in control
group were as likely to maintain regular PFM exercise as those in rx
group. Authors explain this by considering control group’s request for
PFMT at 6 months. Additionally,
about 80% of rx group women were still exercising at 12 mo.
- P intervention costs analysis
results show level of cost per quality-adjusted life-year is considered as
‘worthwhile’ for
- Authors discuss other P studies
with similar findings. In Braekken et al study, PFMT reduced frequency and
bother of P sx and POP-SS score was significantly reduced after PFMT
compared with control (self-instructional manual). Braekken et al also
reported POP-Q stage improved in PFMT group compared with control.
- Authors state that it is becoming
more recognized that P sx do not necessarily correlate with stage of P so
results of this study are not surprising.
- About half of women in control
group received further rx and reported P better at 12 mo.
- Some participants reported
their P was same or worse suggesting some women do no benefit for PFMT and
lifestyle education. Authors
suggest more intensive intervention may be needed for some women. Also suggest that some types and stages
of P do not respond to PFMT as well as other stages.
- P can progress and regress with time. Authors cite several studies demonstrating this premise though results not generalizable to current study because subjects were of different ages and/or subjects were sent questionnaires and were not intentionally seeking medical care.
Strengths
- Pragmatic design, size
(multicenter) and rigor of study
- Outcomes are ‘woman-centered’
- Participant compliance generally high
Limitations
- Lower questionnaire response
rate at 12 mo however standard deviation of POP-SS was smaller than
originally thought maintaining the power needed to identify significant
differences.
- At 6 mo follow up, not all
women had repeat POP-Q. This attrition may have contributed to non-significant
POP-Q finding
- Authors state 12 mo follow up period is short and thus a limitation for this study.
Clinical Application
- Authors state that the outcomes
of their study are woman-centered.
What elements of the study do you think support this statement?
- Though we don’t have details of
the exact patient education information, is there anything additional that
you would include
- Authors state prolapse sx
naturally fluxuate which could affect results of different treatments.
Women may benefit from PT intervention at other times as well. What has
been your experience with women returning for PT services a second, third,
etc time? (postpartum, pessary training, pre or post-surgery).
- For those women who did not
respond to rx, authors suggest more intensive intervention might be needed. What would you include in a ‘more
intensive intervention’ program?
Additional Reading
Burgio KL:
Pelvic floor muscle training for pelvic organ prolpase. Lancet.
2014;383:760-762.
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