Translate

Saturday, November 9, 2013

Surgery versus Physiotherapy for Stress Urinary Incontinence


 Labrie J et al.  New England Journal of Medicine. 2013 Sep 19; 369(12):1124-33

 Journal Club discussion November 6, 2013; Trisha Jenkyns PT, DPT, WCS, BCB-PMD

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

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.