BPH: nonpharmacological approach may work

 A recent study found that in men with lower urinary tract symptoms, nonpharmacologic therapies may be useful, per the TRIUMPH study:  Treating Urinary Symptoms in Men in Primary Healthcare  (see bph nonmed intervention BMJ2023 in dropbox, or BMJ 2023;383:e075219 )

 

Details:

--1077 men with lower urinary tract symptoms (LUTS) within the past five years (48% of those who were invited to participate), were recruited from 30 National Health Service general practice sites in England, from 2018 to 2019

    -- these general practices were randomized to be in either the intervention or usual care groups, with participants in the intervention group receiving a standardized information booklet that was developed with patient and expert input, detailing conservative and lifestyle interventions for men.  General practice nurses, study nurses or health care assistants had contact with the intervention patients over 12 weeks to assist with adherence to the booklet advice

    -- these booklets focused on advice on drinks and liquid intake, how to control an urgent need to urinate, exercises for the pelvic floor muscles to help stop bladder leakage, emptying the bladder as completely as possible, getting rid of the last drops of urine, and reducing sleep disturbances caused by nocturia

    -- men were excluded if they had relevant neurologic disease, were treated for prostate or bladder cancer, had undergone prior prostate surgery, or had poorly controlled diabetes

        -- this booklet is available at: https://www.bmj.com/content/bmj/suppl/2023/11/15/bmj-2023-075219.DC1/dram075219.ww2.pdf

 

Tests done to assess LUTS and quality of life:
    --IPSS (International Prostate Symptom Score): a 7-question written screening tool for BPH, addressing the severity of symptoms, with a score of up to 5 for each one of: incomplete bladder emptying, urinary frequency, amount of stopping and starting urination, urgency, weak stream, straining to urinate, degree of nocturia. An eighth question was added in this evaluation to assess quality-of-life issues

    -- ICIQ-UI-SF (International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form): supplements the IPSS with measurement of incontinence and post-void dribbling; this questionnaire has a clinically meaningful difference for women (i could not find info for men) of 4 points

    -- B-IPQ (Brief Illness Perception Questionnaire): measures participants’ cognitive and emotional perceptions of their LUTS (I could not find the clinically meaningful difference score for B-IPQ for men with LUTS)

 

-- Mean age 69, 99% white, 84% married or civil partnered, deprivation index (a conglomerate of social economic variables expressed in quintiles) 46% were in the least-deprived quintile/27% one tier below that, BMI 27

-- number of comorbidities 0 in 31%/1 in 35%/ >1 in 33%, mean eGFR 77; no urology referral in prior 12 months in 97%

-- urologic symptoms at baseline:

    -- mean IPSS difference (min-max): 14 [the 7 questions of the regular IPSS]

        -- note: this score is a combination of each of the min-max differences for each component; the individual 7 components here each have a min-max difference of 0.8-2.7.

        -- symptom severity by IPSS: mild (score <7) 15%, moderate (score 8-19) 66%, severe (score >19) 20%

    -- mean quality of life score by IPSS (min-max): 3.5 [as per IPSS in general, score 0-5 with 5 being worst for each component]

    -- mean quality of life score by ICIQ-UI-SF: (min-max): 3.7

    -- mean B-IPQ score (min-max): 39

  

-- main outcome: patient-reported IPSS score measured 12 months after the study began, with a target reduction of 2.0 points, felt to reflect a “minimal clinically important difference when baseline IPSS is <20”

-- secondary outcomes: patient-reported quality-of-life, urinary symptoms, and perception of LUTS; hospital referrals; and adverse events at 6 and 12 months

 

Results:

Results below were adjusted for individual level of baseline IPSS and practice-level variables:

--primary outcome, improvement at 12 months:

    -- intervention group: mean 11.6

    -- usual care group: mean 13.9

        -- adjusted difference between arms: -1.81 (-2.66 to -0.95), p<0.001

 

--secondary outcomes:

    -- IPSS improvement at 6 months

        -- intervention group: mean 11.5

        -- usual care group: mean 13.8

            -- adjusted difference: -1.68 (-2.34 to -1.02), p<0.001

    -- ICIQ-UI-SF score (range 0-21), at 6 months:

        -- intervention group: 3.6

        -- usual care group: 4.5

            -- adjusted difference: -0.53 (-1.02 to -0.04), p=0.04

    -- ICIQ-UI-SF score, at 12 months:

        -- intervention group: 3.7

        -- usual care group: 4.5

            -- adjusted difference: -0.74 (-1.15 to -0.33), p<0.001

    -- IPSS quality-of-life score (range 0-6), at 6 months:

        -- intervention group: 3.0

        -- usual care group: 3.35

            -- adjusted difference: -0.29 (-0.43 to -0.15), p<0.001

    -- IPSS quality-of-life score, at 12 months:

        -- intervention group: 2.9

        -- usual care group: 3.3

            -- adjusted difference: -0.34 (-0.50 to -0.18), p<0.001

    -- B-IPQ score (range 0-90), at 6 months:

        -- intervention group: 33.4

        -- usual care group: 38.3

            -- adjusted difference: -5.34 (-6.69 to -3.99), p<0.001

    -- B-IPQ score, at 12 months:

        -- intervention group: 33.8

        -- usual care group: 38.4

            -- adjusted difference: -4.78 (-6.31 to -3.25), p<0.001

 

-- safety issues: essentially none, and the few that happened were no different between the 2 groups

 

 Commentary:

-- LUTS is really common, especially as men age. the cited prevalence in observational studies is quite variable, but on the order of 3-8% for those 31-40yo, 50% in men 52-60yo, 70% in those 60-69yo, and 80% if >80yo; and the overall prevalence is likely to become higher with the aging population

-- LUTS is associated with many different symptoms, including those related to urine storage (urgency, frequency, urgency-related incontinence), voiding (weak or intermittent stream, straining, hesitancy, incomplete emptying), or post-voiding symptoms (dribbling), and is often related to either prostate and/or bladder dysfunction

-- European guidelines, including those from NICE in the UK as well as the European Association of Urology, tend to promote more conservative approaches to LUTS therapy, such as bladder training, advice on fluid intake, and lifestyle advice, with a focus on patient self-management

 

-- This study found that men with a mean IPSS score reflecting moderate severity of LUTS had an improvement of 1.81 points versus the usual care arm of the study. And, this included men with a variety of clinical scenarios, including those with storage or voiding LUTS, postvoid dribbling, and monosymptomatic nocturia (the latter often being associated with conditions other than LUTS)

-- they used a minimal clinically important difference of 2.0 points for the IPSS. This is less than the prior accepted 3.0-point difference for being clinically meaningful. But I think there are some reasons to think their finding of 1.81 is still within range for being clinically significant for many men:

    -- a reasonably large number of individuals in the intervention group will still surpass the 2.0 bar, given a mean difference of -1.81 points (they found a range of -0.95 up to -2.66).

    -- the IPSS score in the usual care group decreased from 14.6 at baseline to 13.9 at 12 months, a 0.7 decrease. part of this decrease was likely because the men in the usual care group volunteered and knew they were in a study; they were likely more motivated to improve than those in the general population even though were not on meds

    -- there should also be a lower bar for nonpharmacologic interventions, since (as per above) no adverse effects were noted, and there is the important positive for many men of empowering them to be active participants in their own care

    -- so, to me it seems reasonable to try the nonpharmacologic approach and use meds as needed.

-- and this was the largest randomized study to date assessing the value of nonpharmacologic intervention for LUTS

 

-- It was interesting in the study that the results for most of the various tests done were better as the 12-month mark than the 6-month mark, despite the fact that the actual interventions by the research nurses and others only lasted for the first 12 weeks (i.e., despite a 12 week intervention/handholding by nurses and healthcare assistants, the overall effect seems to get better at the assessment at 12 months as compared to the one at 6 months)

-- also, there was no difference whether the intervention was done at the different sites by either a study nurse, a practice nurse, or a healthcare assistant

 

Limitations:

-- this study involved predominantly white (99%(, married or partnered men (84%), who were largely in the two top least-deprived 2 quintiles of the UK index of multiple deprivations (73%), limiting the generalizability of these results to the general population in other cohorts

-- the participants were quite healthy and 80% had only mild-to-moderate symptoms, which might limit generalizability of the results to those who are sicker or have more severe symptoms (there are no granular data on outcomes stratified by these variables)

-- only half of the men invited to participate actually agreed to do so. This suggests a strong selection bias in those who did agree to participate, which might limit the generalizability of the results to the overall population. were they more motivated than most men? more oriented to non-pharmacologic interventions?

    -- the usual care group did experience some benefit over the course of the study. This could be because about a third of the patients with LUTS do improve over a five-year time, as found in other studies. But this may also reflect the fact that the usual care group did receive an actual intervention: they completed patient-reported outcomes, received newsletters, and these men in the study may have adopted more LUTS-related behavior changes than might occur in the general population

-- This study was based on primary care interventions by nurses and healthcare assistants, which requires devoting time for these individuals to do this intervention. this situation may be difficult to replicate in some healthcare settings where there are insufficient staff or have other more important priorities

-- one concern with using the IPSS as the major tool for LUTS evaluation is that postvoid dribbling affects half of men and incontinence about one in eight, though neither symptom is part of the IPSS evaluation; the ICIQ-UI-SF does include them (though this latter questionnaire by itself actually revealed only a small and unlikely clinically significant difference in this study)

 

So,

-- this study does raise the important issue that nonpharmacologic therapies may well help many men with LUTS. It seems that the usual go-to approach in these individuals (at least in the US) has been to start medications, but nonpharmacologic approaches may well work in and of themselves in some individuals, as well as potentially in combination with medications if the nonpharmacologic effect is insufficient

-- also, it is notable that healthcare assistants performed as well as nurses in this study, suggesting that non-nurse personnel may well be able to assist patients in the clinic setting. In fact, especially at sites where English is not the primary language of the patient population, healthcare personnel from the community may well be better than some nurses or clinicians in terms of understanding the patients and being able to relate to them more easily

-- as noted above, this booklet used in the intervention group is available: https://www.bmj.com/content/bmj/suppl/2023/11/15/bmj-2023-075219.DC1/dram075219.ww2.pdf

 

geoff

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