Dataset Information

The effectiveness of a treatment protocol for male lower urinary tract symptoms in general practice: a practical randomised controlled trial.

ABSTRACT:

Background

Randomised controlled trials have shown the efficacy of several treatment modalities for lower urinary tract symptoms (LUTS) in selected populations. The effectiveness in daily practice has hardly been investigated, especially in primary care and is dependent on choices between all possible treatment options and best investigated in a comprehensive study, including all treatment modalities (watchful waiting, alpha-blockers, 5-alpha-reductase inhibitors, and surgery).

Aim

Assessment of the effectiveness of a comprehensive treatment protocol for LUTS in primary care.

Design of study

Randomised controlled trial.

Setting

Fourteen general practices in the Netherlands.

Method

Intervention

treatment protocol based on a formalised expert opinion. Control condition: usual care.

Study population

208 subjects with moderate to severe LUTS (IPSS > or =8, median = 13).

Outcome measures

symptom severity (IPSS [International Prostate Symptom Score]), bother score (Dan-PSS [Danish Prostate Symptom Score]), and maximum urinary flow (Q(max)); incidence of acute urinary retention and urinary tract infections.

Results

In the intervention group markedly more subjects used an alpha-blocker at end of follow-up than in the usual care group (24% versus 6%). No significant differences were found between intervention and control group in IPSS, Q(max) or Dan-PSS.

Conclusion

alpha-blockers and watchful waiting are the most frequent treatment modalities for LUTS in primary care. Our study showed no evidence that a protocol using well-defined indications for all possible treatment modalities based on a formalised expert opinion procedure has added value. Based on our results, we cannot recommend a broadening of the indication for alpha-blockers, which, however, seems to be the current trend.

SUBMITTER: Norg RJ

PROVIDER: S-EPMC1934054 | biostudies-literature | 2006 Dec

REPOSITORIES: biostudies-literature

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Publications

The effectiveness of a treatment protocol for male lower urinary tract symptoms in general practice: a practical randomised controlled trial.

Norg Roelf J C RJ van de Beek Kees K Portegijs Piet J M PJ van Schayck C P Onno CP Knottnerus J André JA

The British journal of general practice : the journal of the Royal College of General Practitioners 20061201 533

<h4>Background</h4>Randomised controlled trials have shown the efficacy of several treatment modalities for lower urinary tract symptoms (LUTS) in selected populations. The effectiveness in daily practice has hardly been investigated, especially in primary care and is dependent on choices between all possible treatment options and best investigated in a comprehensive study, including all treatment modalities (watchful waiting, alpha-blockers, 5-alpha-reductase inhibitors, and surgery).<h4>Aim</h ...[more]

PMID: 17132382

Similar Datasets

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.

Project description:ObjectiveTo evaluate the effectiveness of self management as a first line intervention for men with lower urinary tract symptoms.DesignRandomised controlled trial.SettingA teaching hospital and a district general hospital in London.Participants140 men (mean age 63 (SD 10.7) years), recruited between January 2003 and April 2004, referred by general practitioners to urological outpatient departments with uncomplicated lower urinary tract symptoms.InterventionsSelf management and standard care (n=73) or standard care alone (n=67). The self management group took part in three small group sessions comprising education, lifestyle advice, and training in problem solving and goal setting skills.Main outcome measuresThe primary outcome measure was treatment failure measured at 3, 6, and 12 months. Symptom severity (international prostate symptom score; higher scores represent a poorer outcome) was used as a secondary outcome.ResultsAt three months, treatment failure had occurred in 7 (10%) of the self management group and in 27 (42%) of the standard care group (difference=32%, 95% confidence interval 18% to 46%). Corresponding differences in the frequency of treatment failure were 42% (27% to 57%) at six months and 48% (32% to 64%) at 12 months. At three months, the mean international prostate symptom score was 10.7 in the self management group and 16.4 in the standard care group (difference=5.7, 3.7 to 7.7). Corresponding differences in score were 6.5 (4.3 to 8.7) at six months and 5.1 (2.7 to 7.6) at 12 months.ConclusionsSelf management significantly reduced the frequency of treatment failure and reduced urinary symptoms. Because of the large observed benefit of self management, the results of this study support the case for a large multicentre trial to confirm whether self management could be considered as first line treatment for men with lower urinary tract symptoms.Trial registrationNational Research Register N0263115137; Clinical trials NCT00270309 [ClinicalTrials.gov].

Dataset Information

The effectiveness of a treatment protocol for male lower urinary tract symptoms in general practice: a practical randomised controlled trial.

Background

Aim

Design of study

Setting

Method

Intervention

Study population

Outcome measures

Results

Conclusion

Publications

The effectiveness of a treatment protocol for male lower urinary tract symptoms in general practice: a practical randomised controlled trial.

Similar Datasets

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