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Lower urinary tract disease: what are we trying to treat and in whom?

ABSTRACT: The diseases of the lower urinary tract are traditionally divided into abnormalities of storage and abnormalities of emptying. The targets for therapy were the organs most responsible for influencing storage and emptying. Modern understanding places the symptomatic status of the patient as the overriding criterion for treatment. It also accommodates a broader understanding of multiple and overlapping systems. Symptoms of voiding dysfunction have been clearly shown to be associated with symptoms of other genitourinary disease, for example, erectile dysfunction (ED). Treatment of voiding dysfunction has also been shown to have effects (adverse or beneficial) in these other domains. Thus, the symptoms of lower urinary tract disease (LUTD) that have to be considered now as targets relevant to these therapies include ED, ejaculatory dysfunction, sexual desire, sexual pain disorders and female sexual dysfunction. The anatomic, neural and endocrine systems that support these symptomatic functions and dysfunctions span the range from the urogenital smooth muscle to the hypothalamus, the bladder sensory output to the micturition centre and growth factors to androgens. Potentially important targets also include vascular and spinal structures, sex hormones and nitric oxide as well as the obvious genes, enzymes and receptors. The epidemiological studies prove the convergence of LUTD when viewed through the lens of the current patient-related outcomes and problem constructs. This convergence serves as a clear guidance to include wide ranging outcome instruments in all future studies with compounds being investigated for the treatment of LUTD. Out of these will come evidence of expected and unexpected collateral effects. The convergence should open the possibility to a different business model for developing therapeutic concepts. The blockbuster drug for a monolithic indication may be supplemented by agents with single or multiple pathway activity with smaller parallel targets. Using an approach based on patient reported outcomes to therapeutic targets not only widens the range of conditions, but also the patient types who can be considered as having LUTD.

SUBMITTER: Heaton JP

PROVIDER: S-EPMC1751489 | biostudies-other | 2006 Feb

REPOSITORIES: biostudies-other

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Project description:ContextSeveral newer device-based procedures have recently become available for treating men with lower urinary tract symptoms attributed to benign prostatic hyperplasia, but their effectiveness remains uncertain.ObjectiveTo assess the longer-term comparative effectiveness (defined as >12 mo of follow-up) of the newer treatment modalities prostatic urethral lift (PUL), transurethral prostate convective radiofrequency water vapor (Rezūm), Aquablation, and prostatic arterial embolization (PAE).Evidence acquisitionOvid Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and the Agency for Healthcare Research and Quality databases were searched through September 30, 2019; hand searches of references of relevant studies were also performed. Eligible studies were randomized controlled trials (RCTs) published in English language. We excluded observational studies.Evidence synthesisOne RCT (n = 91) found that patients undergoing PUL may be less likely to respond (risk ratio [RR] 0.8; 95% confidence interval [CI] 0.7-1.0; low certainty of evidence [CoE]) and have a higher mean International Prostate Symptom Score (IPSS; mean difference 6.1; 95% CI 2.2-10.0; low CoE) than those undergoing transurethral resection of the prostate (TURP). Among patients undergoing PAE, one small RCT (n = 30) reported similar IPSS response rates (RR 0.9; 95% CI 0.7-1.1; low CoE) and one trial (n = 107) found similar mean IPSS (-0.7; 95% CI -1.3 to 2.7; moderate CoE) scores to those among patients undergoing TURP. A single study on Aquablation reported 12 mo of follow-up only, and a single 3-mo trial compared Rezūm with sham treatment.ConclusionsThe current best evidence underlying these newer therapies is limited to few trials (PUL and PAE), short-term follow-up of 12 mo (Aquablation and Rezūm), or sham comparison only (Rezūm).Patient summaryEvidence for four of the newer surgical treatments for men with an enlarged prostate is limited to few small trials with short-term follow-up; only one trial compared a new treatment modality with sham surgery.

Project description:ObjectivesTo estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care.DesignEconomic evaluation alongside a cluster randomised controlled trial from a UK National Health Service (NHS) perspective with a 12-month time horizon.SettingThirty NHS general practice sites in England.Participants1077 men aged 18 or older identified in primary care with bothersome LUTS.InterventionsA standardised and manualised intervention for the treatment of bothersome LUTS was compared with usual care. The intervention group (n=524) received a standardised information booklet with guidance on conservative treatment for LUTS, urinary symptom assessment and follow-up contacts for 12 weeks. The usual care group (n=553) followed local guidelines between general practice sites.MeasuresResource use was obtained from electronic health records, trial staff and participants, and valued using UK reference costs. Quality-adjusted life-years (QALYs) were calculated from the EQ-5D-5L questionnaire. Adjusted mean differences in costs and QALYs and incremental net monetary benefit were estimated.Results866 of 1077 (80.4%) participants had complete data and were included in the base-case analysis. Over the 12-month follow-up period, intervention and usual care arms had similar mean adjusted costs and QALYs. Mean differences were lower in the intervention arm for adjusted costs -£29.99 (95% CI -£109.84 to £22.63) while higher in the intervention arm for adjusted QALYs 0.001 (95% CI -0.011 to 0.014). The incremental net monetary benefit statistic was £48.01 (95% CI -£225.83 to £321.85) at the National Institute for Health and Care Excellence UK threshold of £20 000 per QALY. The cost-effectiveness acceptability curve showed a 63% probability of the intervention arm being cost-effective at this threshold.ConclusionsCosts and QALYs were similar between the two arms at 12 months follow-up. This indicates that the intervention can be implemented in general practice at neutral cost.Trial registration numberISRCTN11669964.

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Lower urinary tract disease: what are we trying to treat and in whom?

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