SEARCH · PubMed Health

Results for “Randomised Controlled Trial”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 343 records · Page 19Linked to original sources

PubMed2004

Misoprostol in the treatment of postpartum haemorrhage in addition to routine management: a placebo randomised controlled trial.

Postpartum haemorrhage remains a leading cause of maternal mortality, despite treatment with conventional methods. In this randomised controlled trial, we compared misoprostol 600 microg (200 microg orally and 400 microg sublingually) with placebo in the treatment of postpartum haemorrhage in addition to routine treatment. One hundred and sixty consenting women who delivered vaginally with measured blood loss > or =500 mL and for whom inadequate uterine contraction was thought to be a possible factor were given either misoprostol or placebo in addition to normal treatment and after routine active management with uterotonics. Blood loss was measured by collection in a special plastic bedpan and side effects of treatment were recorded. Measured average additional blood loss was 325 mL (95% confidence interval [CI] 265 to 384 mL) with misoprostol and 410 mL (95% CI 323 to 498 mL) with placebo. No severe side effects were noted in the use of misoprostol.

Abortifacient Agents, Nonsteroidal↗

PubMed1996

Exercise therapy for osteoporosis: results of a randomised controlled trial.

OBJECTIVE: To define the effects of therapeutic exercise on bone density and back complaints. METHODS: A randomised controlled trial with parallel groups was conducted in an outpatient clinic, Medical School, University of Vienna. Ninety two sedentary post-menopausal women with back problems were randomly allocated to either exercise (groups 1 and 2) or control (group 3, no exercise, n = 31); the exercise group was retrospectively subdivided into compliant (group 1, n = 27) and not fully compliant patients (group 2, n = 34). Regular, initially supervised therapeutic exercise aimed at restoring biomechanical function was performed for four years. Bone density in the forearm was measured by single photon absorptiometry at entry and after four years; subjective back complaints were documented. RESULTS: A significant decrease in bone density was observed in groups 2 and 3; no change was noted in group 1; back complaints decreased in group 1 only. CONCLUSIONS: Sedentary postmenopausal women may benefit from regular long term therapeutic exercise in terms of subjective back complaints and slowed loss of bone mass.

Absorptiometry, Photon↗

PubMed2005

Randomised controlled trials in Africa of HIV and AIDS: descriptive study and spatial distribution.

OBJECTIVES: To identify and describe randomised controlled trials on HIV and AIDS conducted in Africa and to map their spatial distribution using exact geographic coordinates. DESIGN: Construction and analysis of a database of trials conducted wholly or partly in Africa and reported before 2004. DATA SOURCES: CENTRAL, Medline, Embase, and LILACS. RESULTS: Our comprehensive search yielded 284 distinct records that were potentially eligible for inclusion in the database. Of these, 150 articles reported on 77 eligible trials published or reported from 1987 to 2003. Seven trials were identified exclusively from the CENTRAL database. Trials were conducted in 18 of 48 countries in sub-Saharan Africa. None were conducted in north Africa. Only 19 had a principal investigator located in an African country. Forty two trials assessed prevention and 35 assessed treatment. Most studies were funded by government agencies outside Africa (n = 43), with the pharmaceutical industry providing partial support to 16 of these. The pharmaceutical industry provided full or partial support to a further 18 trials. Only 43 trials reported conducting a power calculation for determining sample size. There was no mention of ethical approval or informed consent in 19 and 17 trials, respectively. CONCLUSION: The relatively small number of HIV/AIDS trials conducted in Africa is not commensurate with the burden of disease. Geographical mapping as an adjunct to prospective trial registration is a useful tool for researchers and decision makers to track existing and future trials.

Africa↗

PubMed1982

A randomised controlled trial of anti-smoking advice: 10-year results.

Ten-year results are reported from a randomised controlled trial of anti-smoking advice in 1445 male smokers, aged 40-59, at high risk of cardiorespiratory disease. After one year reported cigarette consumption in the intervention group (714 men) was one-quarter that of the "normal care" group (731 men); over 10 years the net reported reduction averaged 53%. The intervention group experienced less nasal obstruction, cough, dyspnoea, and loss of ventilatory function. Over 10 years their mortality from coronary heart disease was 18% lower than controls (49 and 62 deaths), and that for lung cancer was 23% lower (18 and 24 deaths). Deaths from non-lung cancers were higher in the intervention group (28 v 12 deaths). This unexpected difference was due about equally to an excess in intervention and a deficiency in normal care men, it showed no site specificity, and it was unrelated to change in smoking habit. These findings suggest that it is more likely to have been due to change than to intervention. The total number of deaths were 123 in the intervention group and 128 in normal care (95% confidence limits of difference -22% to +23%). The policy of encouraging smokers to give up the habit should not be changed.

Adult↗

PubMed2002

Community based rehabilitation after severe traumatic brain injury: a randomised controlled trial.

OBJECTIVE: Evaluation of multidisciplinary community based outreach rehabilitation after severe traumatic brain injury (TBI). METHODS: A randomised controlled trial compared outreach treatment (mean of two sessions a week for 27.3 (SD 19.1) weeks) in community settings such as participants' homes, day centres, or workplaces, with provision of written information detailing alternative resources. Follow up for an average of 24.8 months after initial allocation was by a blinded independent assessor. Participants were aged 16-65, had sustained severe TBI between 3 months and 20 years previously, and had no other neurological conditions. Of 110 initially allocated, 48 outreach and 46 information participants were successfully followed up. Primary outcome measures (Barthel index (BI) and the brain injury community rehabilitation outcome-39 (BICRO-39)) focused on levels of activity and participation. Secondary measures were the functional independence measure and the functional assessment measure (FIM+FAM) and, in a subgroup of 46 participants, the hospital anxiety and depression scale. Analyses were non-parametric. RESULTS: outreach participants were significantly more likely to show gains on the BI and the BICRO-39 total score and self organisation and psychological wellbeing subscales. There were likewise strong trends (p<0.10) for BICRO personal care and mobility, and on the FIM+FAM for personal care and cognitive functions. Differential improvements were not seen for indices of socializing, productive employment, anxiety, or depression. Median changes on individual subscales were small, reflecting the diversity of the clinical population; however, 40% of outreach but only 20% of information participants made a clinically significant improvement of 2+ points on at least one BICRO-39 scale. Time since injury was unrelated to the magnitude of gains. CONCLUSIONS: This is the first RCT of multidisciplinary community rehabilitation after severe TBI, and suggests that even years after injury it can yield benefits which outlive the active treatment period.

Activities of Daily Living↗

PubMed1995

A randomised controlled trial of strategies to prompt attendance for a Pap smear.

OBJECTIVE: To assess the comparative efficacy, by randomised controlled trial, of three interventions designed to encourage "at risk" women to have a Pap smear: an educational pamphlet; letters inviting attendance at a women's health clinic; and letters from physicians. METHODS: Subjects at risk for cervical cancer who had not been adequately screened were identified by a random community survey and randomly allocated to one of the intervention groups or a control group. Six months after intervention implementation, a follow up survey assessed subsequent screening attendance. Self report was validated by comparison with a national screening data base. RESULTS: A significantly greater proportion of women (36.9%) within the group receiving a physician letter reported screening at follow up than in any other group (P = 0.012). The variables most strongly predicting screening attendance were: age, perceived frequency of screening required, use of oral contraceptives, and allocation to receive the physician letter intervention. CONCLUSIONS: The relative efficacy of the GP letter in prompting screening attendance shows that this strategy is worthy of further investigation. There remains a need to examine the barriers to screening for older women, and to develop tailored strategies for this population.

Adolescent↗

PubMed2006

Randomised controlled trials of immediate weight-bearing mobilisation for rupture of the tendo Achillis.

We performed two independent, randomised, controlled trials in order to assess the potential benefits of immediate weight-bearing mobilisation after rupture of the tendo Achillis. The first trial, on operatively-treated patients showed an improved functional outcome for patients mobilised fully weight-bearing after surgical repair. Two cases of re-rupture in the treatment group suggested that careful patient selection is required as patients need to follow a structured rehabilitation regimen. The second trial, on conservatively-treated patients, provided no evidence of a functional benefit from immediate weight-bearing mobilisation. However, the practical advantages of immediate weight-bearing did not predispose the patients to a higher complication rate. In particular, there was no evidence of tendon lengthening or a higher re-rupture rate. We would advocate immediate weight-bearing mobilisation for the rehabilitation of all patients with rupture of the tendo Achillis.

Achilles Tendon↗

PubMed1998

Running a randomised controlled trial in a service setting: a progress report.

This paper will give a progress report on a randomised controlled trial which is currently underway in the Bristol area. Some of the key influencing literature will be summarised, followed by an overview of the study design. The paper will also highlight some of the methodological and practical advantages and disadvantages afforded by the service setting of the study.

Child, Preschool↗

PubMed2004

Does improving communication and information for women increase attendance at colposcopy in an inner city clinic? A randomised controlled trial.

PURPOSE: To establish whether information leaflets and appointment reminders improve attendance for diagnostic colposcopy. DESIGN & SETTING: Randomised controlled trial in an inner city colposcopy clinic. PARTICIPANTS: 500 women newly referred to the colposcopy clinic with abnormal cervical screening smear results were randomly assigned to an intervention or control group using computer-generated numbers. INTERVENTION: 233 women referred for colpoposcopy were sent a comprehensive information leaflet with their appointment details and additionally were sent reminder letters regarding their appointment 7-10 days prior to their appointment date. CONTROL: 267 women were sent the standard basic information prior to their appointment. MAIN OUTCOME MEASURE: Attendance and default rates for diagnostic colposcopy. RESULTS: Default in the intervention arm was 42 out of 233 (18%) compared with 93 out of 267 (35%) in the control arm. CONCLUSION: Improved communication and information in the form of a detailed leaflet and a reminder letter for women with a recently abnormal smear result increased attendance for initial colposcopy assessment.

Adult↗

PubMed1994

Cholesterol reduction and death from non-coronary causes: evidence from randomised controlled trials.

An overview of randomised trials of cholesterol reduction (26 trials, 50,000 patients, net cholesterol reduction approximately 10%) provides clear evidence of a reduction in the incidence of coronary heart disease (CHD) after just a few years of treatment. Overall, the observed reduction in CHD death (9% +/- 3) was only half as large as the reduction in non-fatal myocardial infarction (19% +/- 4), although both were statistically significant (2p < 0.005). In these trials, 60% of all deaths were from CHD, and since treatment reduced these by about 9%, the expected reduction in total deaths was about 5-6%. This expected reduction falls within the 95% confidence interval of the observed effect of cholesterol reduction on total mortality in these trials. There were small excesses of deaths from cancer and deaths from trauma among patients allocated active treatment. However, in no single trial, nor in the trials collectively, were these increases individually statistically significant. Furthermore, the increases did not appear to be specific to any one agent nor were the increases consistent between trials of the same agent. These observations suggest that the small excesses of non-coronary deaths observed in the cholesterol reduction trials may have occurred by chance. Evidence from ongoing longer-term studies of treatments producing larger cholesterol reductions will be useful in further delineating the effects, if any, of such treatments on non-coronary mortality.

Cholesterol↗

PubMed2026

Vaginal Hysterectomy Versus Vaginal Assisted Natural Orifice Transluminal Endoscopic Surgery Hysterectomy; Results of a Randomised Controlled Trial.

OBJECTIVE: To compare Vaginal Hysterectomy (VH) with Vaginal Assisted Natural Orifice Transluminal Endoscopic Surgery (NOTES) hysterectomy (VANH) as a day-care procedure. DESIGN: Single-blind, multicentre randomised controlled trial. SETTING: Two Dutch non-academic teaching hospitals. POPULATION: Women aged ≥ 18 years undergoing hysterectomy for benign indications. METHODS: Women were randomised 1:2 (VH or VANH). Primary outcome was SDD. Secondary outcomes included operative time, rate of elective salpingectomies, intraoperative blood loss, complications (Clavien-Dindo), pain scores (NRS) and analgesic use, post-operative recovery (RI-10), and quality of life (EQ-5D-5L). Analyses were performed on an intention-to-treat basis. RESULTS: A total of 113 patients were included in the analyses (n = 42 VH, and n = 71 VANH). SDD occurred significantly more frequently in the VANH group (87.3%) than VH group (71.4%; OR 2.76, 95% CI 1.04-7.25; p = 0.04). VANH was associated with a significantly shorter operative time (median 55 min versus 65 min; p = 0.005), less blood loss (median 50 mL vs. 150 mL; p < 0.001) and more often elective opportunistic salpingectomy compared to VH (100% vs. 77.4%; p = 0.008). NRS were significantly lower in the VANH group the first hour post-operative (3 vs. 1, p < 0.001). Post-operative complications (VH 9.5% vs. VANH 15.5%; p = 0.34), readmission (VH 4.8% vs. VANH 8.5%; p = 0.47), analgesic use, recovery, and quality of life were not statistically significant. CONCLUSIONS: VANH is a safe and effective alternative to VH, offering a higher likelihood of SDD, shorter operative time, reduced blood loss, and more often an elective salpingectomy, without increased complications or differences in pain, recovery, or quality of life.

Humans↗

PubMed2004

Sooner and healthier: a randomised controlled trial and interview study of an early discharge rehabilitation service for older people.

BACKGROUND: Hospitals are under pressure from admissions of increasing numbers of older people. Older people may suffer unnecessary activity limitation after acute illnesses through lack of appropriate rehabilitation. OBJECTIVE: To evaluate an early discharge and rehabilitation service for older people. DESIGN: A randomised controlled trial comparing an early discharge and rehabilitation with standard hospital aftercare. Outcome measures assessed at 3 and 12 months were the Barthel Index, Nottingham Extended Activities of Daily Living and EuroQol (for patients) the General Health Questionnaire (for patients and carers). Use of services over 12 months was recorded. An interview study of patients and staff was conducted. SETTING AND INTERVENTION: The early discharge and rehabilitation service offered a home-based rehabilitation and care programme for up to 4 weeks. PARTICIPANTS: 370 hospitalised older medical and surgical patients were included in the randomised controlled trial. Twenty patients and 11 staff were interviewed. RESULTS: Subjects in the early discharge rehabilitation service group used fewer days in hospital at 3 months (mean difference 9, median difference 4 days, 95% CI of median difference 2-8). At 3 months the early discharge and rehabilitation service patients had better Barthel scores (mean difference 1.2, 95% CI 0.4-1.9), Nottingham Extended Activities of Daily Living kitchen scores (mean difference 1.2, 95% CI 0.2-2.3), Nottingham Extended Activities of Daily Living domestic scores (mean difference 1.1, 95% CI 0.2-2.0) and General Health Questionnaire scores (mean difference 2.4, 95% CI 0.7-4.1). Significant Nottingham Extended Activities of Daily Living domestic and General Health Questionnaire benefits remained at 12 months. The early discharge and rehabilitation service carers had better General Health Questionnaire scores at 3 months (mean difference 2.0, 95% CI 0.1-3.8). The interviews suggested that the early discharge and rehabilitation service was patient-centred, set clear goals, worked as a team, and considered physical, psychological, social and environmental issues. It was found to be highly satisfactory. CONCLUSIONS: Some older people can be discharged from hospital sooner, with better health outcomes using a well-staffed and organised patient-centred early discharge service providing rehabilitation.

Activities of Daily Living↗

PubMed2002

Sahaja yoga in the management of moderate to severe asthma: a randomised controlled trial.

BACKGROUND: Sahaja Yoga is a traditional system of meditation based on yogic principles which may be used for therapeutic purposes. A study was undertaken to assess the effectiveness of this therapy as an adjunctive tool in the management of asthma in adult patients who remained symptomatic on moderate to high doses of inhaled steroids. METHODS: A parallel group, double blind, randomised controlled trial was conducted. Subjects were randomly allocated to Sahaja yoga and control intervention groups. Both the yoga and the control interventions required the subjects to attend a 2 hour session once a week for 4 months. Asthma related quality of life (AQLQ, range 0-4), Profile of Mood States (POMS), level of airway hyperresponsiveness to methacholine (AHR), and a diary card based combined asthma score (CAS, range 0-12) reflecting symptoms, bronchodilator usage, and peak expiratory flow rates were measured at the end of the treatment period and again 2 months later. RESULTS: Twenty one of 30 subjects randomised to the yoga intervention and 26 of 29 subjects randomised to the control group were available for assessment at the end of treatment. The improvement in AHR at the end of treatment was 1.5 doubling doses (95% confidence interval (CI) 0.0 to 2.9, p=0.047) greater in the yoga intervention group than in the control group. Differences in AQLQ score (0.41, 95% CI -0.04 to 0.86) and CAS (0.9, 95% CI -0.9 to 2.7) were not significant (p>0.05). The AQLQ mood subscale did improve more in the yoga group than in the control group (difference 0.63, 95% CI 0.06 to 1.20), as did the summary POMS score (difference 18.4, 95% CI 0.2 to 36.5, p=0.05). There were no significant differences between the two groups at the 2 month follow up assessment. CONCLUSIONS: This randomised controlled trial has shown that the practice of Sahaja yoga does have limited beneficial effects on some objective and subjective measures of the impact of asthma. Further work is required to understand the mechanism underlying the observed effects and to establish whether elements of this intervention may be clinically valuable in patients with severe asthma.

Adolescent↗

PubMed2003

A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA) in the treatment of chronic pelvic pain: The trial protocol [ISRCTN41196151].

BACKGROUND: Chronic pelvic pain is a common condition with a major impact on health-related quality of life, work productivity and health care utilisation. The cause of the pain is not always obvious as no pathology is seen in 40-60% of the cases. In the absence of pathology there is no established treatment. The Lee-Frankenhauser sensory nerve plexuses and parasympathetic ganglia in the uterosacral ligaments carry pain from the uterus, cervix and other pelvic structures. Interruption of these nerve trunks by laparoscopic uterosacral nerve ablation (LUNA) may alleviate pain. However, the balance of benefits and risks of this intervention have not been reliably assessed. LUNA has, nevertheless, been introduced into practice, although there remains controversy regarding indications for LUNA. Hence, there is an urgent need for a randomised controlled trial to confirm, or refute, any worthwhile effectiveness. The principal hypothesis is that, in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score </= 5) LUNA alleviates pain and improves life quality at 12 months. METHODS/DESIGN: The principal objective is to test the hypothesis that in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score </= 5) LUNA alleviates pain and improves life quality at 12 months. A multi-centre, prospective, randomised-controlled-trial will be carried out with blind assessment of outcomes in eligible consenting patients randomised at diagnostic laparoscopy to LUNA (experimental group) or to no pelvic denervation (control group). Postal questionnaires including visual analogue scale for pain (primary outcome), an index of sexual satisfaction and the EuroQoL 5D-EQ instrument (secondary outcomes) will be administered at 3, 6 and 12 months. The primary assessment of the effectiveness of LUNA will be from comparison of outcomes at the one-year follow-up, although the medium-term and longer-term risks and benefits of LUNA will also be evaluated.The sample size for this trial has been estimated as 420 patients in total using the hypothesis that LUNA will alleviate pain symptoms (i.e. reduce pain scores on a VAS) more than no intervention at one-year following diagnostic laparoscopy and taking into consideration 20% loss to follow-up. The intention to treat analysis to address the principal research questions will be conducted using the one-year follow-up data.

Journal Article↗

PubMed1999

Randomised controlled trials of ursodeoxycholic-acid therapy for primary biliary cirrhosis: a meta-analysis.

BACKGROUND: Ursodeoxycholic acid (UDCA) is the only approved treatment for primary biliary cirrhosis, but its effect on disease progression and survival is uncertain. The aim of this study was to clarify the efficacy of UDCA in primary biliary cirrhosis. METHODS: A systematic review, including the use of meta-analysis, was done for the randomised and switch-over phases of trials comparing UDCA with placebo, obtained from Medline and Embase databases, and from manual searches derived from review articles and abstracts of major international meetings. All trials had more than a mean of 6 months' follow-up and only included patients with primary biliary cirrhosis (PBC) according to established diagnostic criteria. FINDINGS: 17 relevant articles were identified: 11 randomised controlled trials, including 1272 patients, and six reports of the switch-over phases. UCDA had a favourable effect on liver biochemistry in most of the studies but not on symptoms or the progression of histological stage; two studies did not assess survival, liver transplantation, or complications of liver disease. Meta-analysis showed no difference between UDCA and placebo in the incidence of death (odds ratio 1.21, 95% CI 0.71-2.04), liver related death (0.72, 0.22-2.32), liver transplantation (1.27, 0.78-2.07), death or liver transplantation (1.26, 0.87-1.82), and in the development of complications of liver disease (1.11, 0.64-1.92). With the primary end point defined by the authors (a combined end point in three studies, and death or liver transplantation in the others) an odds ratio of 1.53 (0.97-2.42) was obtained. Assessment of the switch-over phases, during which there was a longer follow-up, did not change the results of the meta-analysis. INTERPRETATION: Published randomised controlled trials of UDCA do not show evidence of therapeutic benefit in PBC and its use as standard therapy needs to be re-examined.

Evidence-Based Medicine↗

PubMed2006

Personally addressed hand-signed letters increase questionnaire response: a meta-analysis of randomised controlled trials.

BACKGROUND: Postal questionnaires are commonly used to collect data for health studies, but non-response reduces study sample sizes and can introduce bias. Finding ways to increase the proportion of questionnaires returned would improve research quality. We sought to quantify the effect on response when researchers address participants personally by name on letters that accompany questionnaires. METHODS: All randomised controlled trials in a published systematic review that evaluated the effect on response of including participants' names on letters that accompany questionnaires were included. Odds ratios for response were pooled in a random effects meta-analysis and evidence for changes in effects over time was assessed using random effects meta-regression. RESULTS: Fourteen randomised controlled trials were included covering a wide range of topics. Most topics were unrelated to health or social care. The odds of response when including participants' names on letters were increased by one-fifth (pooled OR 1.18, 95% CI 1.03 to 1.34; p = 0.015). When participants' names and hand-written signatures were used in combination, the effect was a more substantial increase in response (OR 1.45, 95% CI 1.27 to 1.66; p < 0.001), corresponding to an absolute increase in the proportion of questionnaires returned of between 4% and 10%, depending on the baseline response rate. There was no evidence that the magnitude of these effects had declined over time. CONCLUSION: This meta-analysis of the best available evidence indicates that researchers using postal questionnaires can increase response by addressing participants by name on cover letters. The effect appears to be enhanced by including hand-written signatures.

Communication↗

PubMed2004

A randomised controlled trial of insulin lispro given before or after meals in pregnant women with type 1 diabetes--the effect on glycaemic excursion.

In order to study the glucose excursion associated with pre- and postprandial administration a randomised controlled trial with patients randomised to receive insulin lispro (IL) immediately before or after a standardised meal was performed. Pregnant women with diabetes who were treated with IL as part of a basal bolus regime were asked to bring their own usual lunch and administer their own IL. Maternal glycaemia was monitored preprandially and then at 15-minute intervals for 3 hours following the first bite of lunch. Glucose excursions were calculated by subtracting the preprandial glucose level from the subsequent values at each time point. Each woman was invited to attend on four occasions. On two random occasions she was asked to administer her IL after completing her meal and on two occasions IL was administered immediately before her meal. Nine women completed a total of 27 meals (14 preprandial IL and 13 postprandial IL). There was no significant difference between the mean (SD) fasting values between the two groups, before 5.8 (2.8) and after 5.7 (2.0) mmol/l. At each time-point there was no significant difference between the mean blood glucose excursion in the two groups. No patient suffered a hypoglycaemic attack and there was no evidence of fetal compromise. In the two groups there was a marked similarity in the glycemic excursion following a standard meal, whether or not IL was given before or after eating. Postprandial administration of IL may increase the flexibility of IL usage in pregnant women with diabetes.

Adult↗

PubMed2000

Invasive and minimally invasive treatment modalities for lower urinary tract symptoms: what are the relevant differences in randomised controlled trials?

OBJECTIVES: This manuscript reviews the outcomes of invasive and minimally-invasive treatments of lower urinary tract symptoms due to prostatic enlargement. METHODS: The MEDLINE database was searched for Medical Subject headings and text words including prostatic hyperplasia, treatment, surgery, thermal treatments, thermotherapy, laser, TUNA and vaportrode. Data from both randomised and non-randomised controlled trials were considered. RESULTS: All invasive treatments produce significant changes of all subjective and objective outcome parameters. The best clinical outcome has been reported for open prostatectomy followed by transurethral resection of the prostate. Complications of the different invasive techniques were difficult to analyse because of the heterogeneity of categories among different papers and lack of standard criteria. The major attraction of all minimally invasive treatment options is the low risk of bleeding requiring blood transfusions. Retrograde ejaculation was one of the most frequently reported complications for all invasive techniques. Some of the so-called less invasive treatment options appeared to be associated with a rather high incidence of minor complications somehow contradicting their minimally invasiveness. Re-treatment rate observed in patients receiving various minimally invasive treatments was always higher than following standard treatment options such as transurethral resection. CONCLUSIONS: Open prostatectomy and transurethral resection of the prostate outperform all minimally invasive treatment modalities as regards efficacy and durability of outcome. The lack of standard criteria to evaluate complications and side effects makes treatment comparisons difficult. Endorsement of the clinical research criteria proposed by the last WHO-sponsored International Consultation on BPH is strongly recommended to improve the clinical value of randomised and non-randomised controlled trials. More information is needed on long-term complications and cost-effectiveness of minimally invasive treatment modalities.

Humans↗