Primary Aim: To compare mid-urethral sling surgery
vs. physiotherapy for the treatment of SUI
Study Design: Multicenter RCT from the Netherlands,
which allowed subjects to cross-over from one treatment to the other.
o “If a woman was dissatisfied with
the result of the assigned treatment, she was allowed to cross over to the
alternative treatment, which is consistent with usual clinical practice, but
data were analyzed according to the intention- to-treat principle.” Page 1126
Study Population: For 2 years from March 2008 through May
2010, a total of 656 women with SUI or MUI in which SUI was predominant …these
women were asked to participate in the study; 460 gave written informed consent
and were randomly assigned to the surgery or PT group. The
treatment assignments were not concealed.
·
Inclusion criteria
o Women aged 35-80 years with symptoms of
moderate to severe, predominant SUI
o Determining SUI predominance was confusing
reading this article… ON Page 1125 top and right side, it is stated: “SUI was
considered predominant using the validated Dutch version of the Urogenital
Distress inventory” and the reference listed is #13. It looks like the text is incorrect, but the
reference is correct, as it is not possible to determine SUI from UUI using the
UDI.
§ #13 reference: Protocol for Physiotherapy Or TVT
Randomised Efficacy Trial
(PORTRET) by Labrie et al. BMC Womens Health 2009;9:24.
·
This
article states: SUI
predominance was determined according to the Stress/Urge Incontinence
Questionnaire (S/UIQ); SUI events outnumbered UUI events… It is a 2 item questionnaire used to
differentiate between symptoms of stress and urge urinary incontinence
·
Two
questions were asked:
1. “How many times in the last seven
days have you had an accidental leakage of urine onto your clothing, underwear,
or pad…during an activity such as coughing, sneezing, laughing, running,
exercising or lifting? Symptom of stress urinary incontinence (SUI)?”
2. “How many times in the last seven
days have you had an accidental leakage of urine onto your clothing, underwear,
or pad…with a sudden strong need to pass water that you could not reach the
toilet in time? Symptom of urge urinary incontinence (UUI)?”
o For predominant stress urinary incontinence
the number of SUI events should outnumber the number of UUI
o Severity was determined according to
the Sandvik severity index.
o Urodynamic testing was not
mandatory for eligibility and if performed subjects were not excluded
o The actual dx of SUI was based on
the occurrence of urine leakage when straining or coughing with a bladder
volume of at least 300 ml
·
Exclusion
criteria
o Post-void bladder volume greater than
100 ml
o Hx of anti-incontinence surgery
o PFMT by a specialized PT for UI more than 6 months before
randomization
o Genital organ prolapse Stage 2 or more
according to POP-Q
o Women planning for future pregnancy and
childbirth
o Any surgical risks, or current major
psychiatric illness decided by MD
o Hx of recurrent UTI’s; more than 3
times/year
o Difficulty with the Dutch language
o History of chronic neurological disease,
MS
Methods
·
Surgery Group-performed by 49 gynecologists and urologists; N = 230
o Both retropubic and
trans-obturator midurethral-sling surgical techniques allowed.
§ All surgeons performed a minimum
of 20 procedures prior to participating
o 11.2% crossed over to PT following
surgery…22 women received
additional PT with symptoms of PFM hyperactivity & obstructive micturition,
and underwent training to relax the pelvic floor muscles.
·
Physiotherapy Group-PT performed by 83 of the 478 certified pelvic
physiotherapists in the
Netherlands; N=
230
o PFMT for SUI was performed according to the
2003 Dutch guidelines
§ A supervised program to help
women build up to 8 to 12 maximal contractions three times per day was provided
§ Treatment was 1/week or every 2
weeks, depending on the severity of symptoms, treatment goals, adherence, and
the women’s ability to perform PFM contractions
·
If
a woman was unable to contract her PFM; touch, tapping, and massage
were applied to
increase awareness of these muscles
·
Biofeedback-assisted
or functional e-stim could be used
·
The
physiotherapist determined the number of sessions, with a planned
number of nine
sessions within 9 to 18 weeks which was the standard
treatment number
at the time
o Education included function of
the pelvic-floor muscles, bladder function, and how to perform a correct
pelvic-floor muscle contraction
o Women were taught to perform the
Knack
o 49% crossed over to surgery…that’s 99 women crossed over to the
surgery group, after a mean (±SD) time of 31.7±12.7 weeks.
§ IN ADDITION…the mean # of PT sessions
was 9.1 +/- 4.9 in the PT only AND
7.4 +/- 4.4 for
those that ended up crossing over to the surgery group.
Outcomes
·
Data
collected at baseline - either on the day of surgery or the first PT session
and at 2, 4, 6, 12, and 18 months by 13 research nurses covering all clinical
sites
·
The
primary outcome was the Patient Global Impression of Improvement index (PGI-I;
7-point scale) measuring subjective improvement of SUI symptoms…the data at 12
months is found on Table 2
o PGI-I responses were also
assessed at 2, 4, 6, and 18 months to monitor changes (this data is available in the
Supplementary Appendix; Table S2-see below)
·
Changes
in perceived severity of incontinence were assessed using the Patient Global
Impression of
Severity index (PGI-S;
4-point Likert scale).
·
Secondary
outcomes
o Urogenital symptom improvement -
measured by Dutch version of the UDI
o Disease-specific quality of life
- measured by IIQ
o Subjective cure of SUI was
defined as a negative response to the question, “Do you experience urine
leakage related to physical activity, coughing, or sneezing?”
o Objective cure was defined as no
incontinence observed during a cough stress test at a bladder volume of at
least 300 ml
§ The cough test was performed at
the clinical evaluation at 12 months.
§ For…Adverse events, including new
urinary symptoms; A standardized case-report
form was used
Statistical Analysis
·
A modified intention-to-treat analysis which
means that data are analyzed according to original random assignments
regardless of what treatment they received
·
Also
done was a post hoc per-protocol
analysis of outcomes among women who underwent physiotherapy only, women
who underwent surgery after physiotherapy, and women who underwent initial
surgery was performed
Statistical Analysis
& Results
o Descriptive
statistics were
used to analyze baseline characteristics (Table
1)
§ No significant between-group
differences were found in terms of characteristics
§ Baseline UDI & IIQ scores
were similar
·
Intention-to-Treat Analysis …this means that data are analyzed
according to original random assignments regardless of what treatment they
received
·
Analyses
of the Primary
& secondary outcomes for the Surgery Group vs. PT Group at 12 months was performed for 196 in the Surgery
group and 174 in PT group …Table 2
·
They
list both original & imputed data (F/U assessments prior to 12 months are
in the Supplementary Appendix)
o Primary outcome-PGI-I: looked Subjective
improvement-
§ Surgery
group 90.8% vs. PT group 64.4% reported subjective improvement
§ Difference of 26.4 percentage points at
a 95% confidence interval (18.1 to 34.5)
o Secondary Outcome-Subjective Cure
(measured with UDI question “Do you experience urine leakage related to
physical activity, coughing or sneezing?) –
§ Surgery
group 85.2% vs. PT 53.4% reported
subjective cure
§ With absolute difference of 31.8
percentage points at 95% CI (27.6-40.3)
o Objective Cure (defined as neg. provocative cough stress test with
300 ml filled bladder )
§ Surgery
group 76.5% vs. PT group 58.8% did not leak
§ With absolute difference 17.8
percentage points at 95% CI (7.9-27.3)
·
UDI
& IIQ domain scores: both treatment groups had significant improvement
compared to baseline
o UDI: authors make note of UI & OAB
scores being significantly greater in surgery group
o IIQ: authors make note of significantly
greater improvements in mobility & embarrassment scores for the surgery
group, but again with only moderate effect sizes
Adverse Events
·
Adverse
events are summarized for both groups in Table 3
·
A
total of 65 adverse events occurred in 41 (9.8%) of 417 women
o All adverse events were related
to surgery.
§ Bladder and vaginal perforation, successfully
treated during surgery without further clinical implications
§ 3 women had a recorded blood loss
of 500 ml or more
§ One woman needed additional surgery
to loosen the synthetic sling because of persistent voiding problems, and six
reoperations were performed for tape exposure
Post Hoc Per-Protocol
Analysis of Primary & Secondary Outcomes at 12 months (Table
4)
§ Briefly, this analysis compared
women who underwent only PT (103 women), women who
underwent
surgery after PT (99 women) and women who underwent initial surgery only ( 215
women)
o The reported improvement was
lower among women who underwent PT only vs. Surgery after PT group
o Reported improvement was also lower
for the PT only compared to Initial surgery
o PT only group ALSO had lower
frequencies of subjective and objective cure compared to both groups that
underwent Surgery
o Similar outcomes for Surgery
after PT & Initial surgery
·
In
the Supplementary Appdx; authors looked at the last PGI-I assessment for the 21
women in PT
only group
that were lost to F/U
o They found that 76% of women (16
of 21) reported no improvement (Table S3)
Strengths of study,
as stated by and according to authors
·
Randomized
design and inclusion of a variety of centers
·
Allowing
both the transobturator and retropubic surgical techniques for the placement
of polypropylene tape, the range of typical clinical practice was represented
in the surgery group
·
Complications
of surgery were limited and were consistent with those seen in prior studies of
sling surgery
·
Patient-reported
outcomes because clinicians’ assessments have often been shown to underestimate
the degree of symptom-related distress perceived by women
·
The
frequency of improvement in the surgery group (90.8%) was slightly higher than
that reported in the literature (68 to 87%)
o Heterogeneity in the study
design, patient population, interventions, and outcome measures
may account for this difference
·
The improvement rate (64.4%) observed in PT group, which
included women who crossed over to surgery, was higher than the rates in two
other PT studies, which did not allow crossover (33% and 43%)
o The crossover rate is the most likely
explanation; the frequency of improvement among women who did not cross over to
surgery (31.7%) is similar to the frequencies in the other studies
·
In
contrast to the findings in another prior study, the
rate of subjective cure (15.9%) in the physiotherapy group was lower than the
rate of objective cure (44.0%)
o Authors state; it is possible
that women who underwent physiotherapy were able to control their pelvic-floor
muscles during the clinical provocative cough test yet still had stress urinary
incontinence in everyday life in response to unexpected events
Limitations per
authors
·
Selection
bias may have occurred.
o Women with a preference for
surgery may have been more likely to participate in the study, because they
otherwise would have received initial physiotherapy according to Dutch
guidelines.
·
1/5th
of the study population had undergone physiotherapy more than 6 months before
entering the trial. If any had a
negative experience with prior PT, this may have negatively affected their
adherence to the study regimen and the number of sessions they attended, which
could have resulted in a lower efficacy of physiotherapy.
o Authors state this possibility is
not supported by the data, because in the physiotherapy group, prior
physiotherapy was similarly frequent among those who crossed over to surgery
and those who did not
·
Authors
stated, “The high crossover rate (49.0%) among women assigned to the
physiotherapy
group complicates the
interpretation of results, because we used a modified intention-to-treat
analysis. To
address this problem, we performed a post hoc per-protocol analysis, which
showed a
favorable effect
of additional surgery in the physiotherapy group.”
Author’s Discussion
& Summary
·
“Women
randomly assigned to undergo initial surgery were significantly more likely to
have
improvement at 12 months than were those assigned to
receive initial physiotherapy.”
·
The
benefits of surgery persisted in analyses involving multiple imputation of
missing data
·
In
per-protocol analysis, women in the physiotherapy group who crossed over to the
surgery group
had outcomes that were similar to those among women
who underwent initial surgery, whereas
women who underwent only physiotherapy had
significantly less favorable outcomes
·
Women
with moderate-to-severe SUI have significantly better subjective and objective
outcomes at
12 months after surgery than after physiotherapy
·
Findings
“suggest” that women with SUI should be counseled regarding both PFMT and
midurethral-sling surgery as initial treatment option
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