RESUMO
OBJECTIVE: To assess the comparative effectiveness and ranking of minimally invasive treatments (MITs) for lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: We searched multiple databases up to 24 February 2021. We included randomized controlled trials assessing the following treatments: convective radiofrequency water vapour thermal therapy (WVTT; or Rezum); prostatic arterial embolization (PAE); prostatic urethral lift (PUL; or Urolift); temporary implantable nitinol device (TIND); and transurethral microwave thermotherapy (TUMT) compared to transurethral resection of the prostate (TURP) or sham surgery. We performed a frequentist network meta-analysis. RESULTS: We included 27 trials involving 3017 men. The overall certainty of the evidence of most outcomes according to GRADE was low to very low. Compared to TURP, we found that PUL and PAE may result in little to no difference in urological symptoms, while WVTT, TUMT and TIND may result in worse urological symptoms. MITs may result in little to no difference in quality of life, compared to TURP. MITs may result in a large reduction in major adverse events compared to TURP. We were uncertain about the effects of PAE and PUL on retreatment compared to TURP, however, TUMT may result in higher retreatment rates. We were very uncertain of the effects of MITs on erectile function and ejaculatory function. Among MITs, PUL and PAE had the highest likelihood of being the most efficacious for urinary symptoms and quality of life, TUMT for major adverse events, WVTT and TIND for erectile function and PUL for ejaculatory function. Excluding WVTT and TIND, for which there were only studies with short-term (3-month) follow-up, PUL had the highest likelihood of being the most efficacious for retreatment. CONCLUSIONS: Minimally invasive treatments may result in similar or worse effects concerning urinary symptoms and quality of life compared to TURP at short-term follow-up.
Assuntos
Disfunção Erétil , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Disfunção Erétil/etiologia , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos , Metanálise em Rede , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Qualidade de Vida , Ressecção Transuretral da Próstata/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: A variety of minimally invasive treatments are available as an alternative to transurethral resection of the prostate (TURP) for management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). However, it is unclear which treatments provide better results. OBJECTIVES: Our primary objective was to assess the comparative effectiveness of minimally invasive treatments for lower urinary tract symptoms in men with BPH through a network meta-analysis. Our secondary objective was to obtain an estimate of relative ranking of these minimally invasive treatments, according to their effects. SEARCH METHODS: We performed a comprehensive search of multiple databases (CENTRAL, MEDLINE, Embase, Scopus, Web of Science and LILACS), trials registries, other sources of grey literature, and conference proceedings, up to 24 February 2021. We had no restrictions on language of publication or publication status. SELECTION CRITERIA: We included parallel-group randomized controlled trials assessing the effects of the following minimally invasive treatments, compared to TURP or sham treatment, on men with moderate to severe LUTS due to BPH: convective radiofrequency water vapor therapy (CRFWVT); prostatic arterial embolization (PAE); prostatic urethral lift (PUL); temporary implantable nitinol device (TIND); and transurethral microwave thermotherapy (TUMT). DATA COLLECTION AND ANALYSIS: Two review authors independently screened the literature, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model for pair-wise comparisons and a frequentist network meta-analysis for combined estimates. We interpreted them according to Cochrane methods. We planned subgroup analyses by age, prostate volume, and severity of baseline symptoms. We used risk ratios (RRs) with 95% confidence intervals (CIs) to express dichotomous data and mean differences (MDs) with 95% CIs to express continuous data. We used the GRADE approach to rate the certainty of evidence. MAIN RESULTS: We included 27 trials involving 3017 men, mostly over age 50, with severe LUTS due to BPH. The overall certainty of evidence was low to very low due to concerns regarding bias, imprecision, inconsistency (heterogeneity), and incoherence. Based on the network meta-analysis, results for our main outcomes were as follows. Urologic symptoms (19 studies, 1847 participants): PUL and PAE may result in little to no difference in urologic symptoms scores (MD of International Prostate Symptoms Score [IPSS]) compared to TURP (3 to 12 months; MD range 0 to 35; higher scores indicate worse symptoms; PUL: 1.47, 95% CI -4.00 to 6.93; PAE: 1.55, 95% CI -1.23 to 4.33; low-certainty evidence). CRFWVT, TUMT, and TIND may result in worse urologic symptoms scores compared to TURP at short-term follow-up, but the CIs include little to no difference (CRFWVT: 3.6, 95% CI -4.25 to 11.46; TUMT: 3.98, 95% CI 0.85 to 7.10; TIND: 7.5, 95% CI -0.68 to 15.69; low-certainty evidence). Quality of life (QoL) (13 studies, 1459 participants): All interventions may result in little to no difference in the QoL scores, compared to TURP (3 to 12 months; MD of IPSS-QoL score; MD range 0 to 6; higher scores indicate worse symptoms; PUL: 0.06, 95% CI -1.17 to 1.30; PAE: 0.09, 95% CI -0.57 to 0.75; CRFWVT: 0.37, 95% CI -1.45 to 2.20; TUMT: 0.65, 95% CI -0.48 to 1.78; TIND: 0.87, 95% CI -1.04 to 2.79; low-certainty evidence). Major adverse events (15 studies, 1573 participants): TUMT probably results in a large reduction of major adverse events compared to TURP (RR 0.20, 95% CI 0.09 to 0.43; moderate-certainty evidence). PUL, CRFWVT, TIND and PAE may also result in a large reduction in major adverse events, but CIs include substantial benefits and harms at three months to 36 months; PUL: RR 0.30, 95% CI 0.04 to 2.22; CRFWVT: RR 0.37, 95% CI 0.01 to 18.62; TIND: RR 0.52, 95% CI 0.01 to 24.46; PAE: RR 0.65, 95% CI 0.25 to 1.68; low-certainty evidence). Retreatment (10 studies, 799 participants): We are uncertain about the effects of PAE and PUL on retreatment compared to TURP (12 to 60 months; PUL: RR 2.39, 95% CI 0.51 to 11.1; PAE: RR 4.39, 95% CI 1.25 to 15.44; very low-certainty evidence). TUMT may result in higher retreatment rates (RR 9.71, 95% CI 2.35 to 40.13; low-certainty evidence). Erectile function (six studies, 640 participants): We are very uncertain of the effects of minimally invasive treatments on erectile function (MD of International Index of Erectile Function [IIEF-5]; range 5 to 25; higher scores indicates better function; CRFWVT: 6.49, 95% CI -8.13 to 21.12; TIND: 5.19, 95% CI -9.36 to 19.74; PUL: 3.00, 95% CI -5.45 to 11.44; PAE: -0.03, 95% CI -6.38, 6.32; very low-certainty evidence). Ejaculatory dysfunction (eight studies, 461 participants): We are uncertain of the effects of PUL, PAE and TUMT on ejaculatory dysfunction compared to TURP (3 to 12 months; PUL: RR 0.05, 95 % CI 0.00 to 1.06; PAE: RR 0.35, 95% CI 0.13 to 0.92; TUMT: RR 0.34, 95% CI 0.17 to 0.68; low-certainty evidence). TURP is the reference treatment with the highest likelihood of being the most efficacious for urinary symptoms, QoL and retreatment, but the least favorable in terms of major adverse events, erectile function and ejaculatory function. Among minimally invasive procedures, PUL and PAE have the highest likelihood of being the most efficacious for urinary symptoms and QoL, TUMT for major adverse events, PUL for retreatment, CRFWVT and TIND for erectile function and PUL for ejaculatory function. AUTHORS' CONCLUSIONS: Minimally invasive treatments may result in similar or worse effects concerning urinary symptoms and QoL compared to TURP at short-term follow-up. They may result in fewer major adverse events, especially in the case of PUL and PAE; resulting in better rankings for symptoms scores. PUL may result in fewer retreatments compared to other interventions, especially TUMT, which had the highest retreatment rates at long-term follow-up. We are very uncertain about the effects of these interventions on erectile function. There was limited long-term data, especially for CRFWVT and TIND. Future high-quality studies with more extended follow-up, comparing different, active treatment modalities, and adequately reporting critical outcomes relevant to patients, including those related to sexual function, could provide more information on the relative effectiveness of these interventions.
Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Humanos , Sintomas do Trato Urinário Inferior/cirurgia , Sintomas do Trato Urinário Inferior/terapia , Masculino , Pessoa de Meia-Idade , Metanálise em Rede , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Qualidade de Vida , Ressecção Transuretral da Próstata/efeitos adversosRESUMO
PURPOSE: To assess the effects of Serenoa repens alone or in combination with other phytotherapy compared to placebo in men with LUTS due to benign prostatic enlargement. MATERIALS AND METHODS: Following a registered protocol (CRD42021226655), we searched (December 2020) MEDLINE, CENTRAL, Embase, ClinicalTrials.gov, WHO-ICTRP trials platform and other sources with no restrictions on language, publication date or status. We included randomized controlled trials, and we critically appraised them using the Cochrane Tool for Risk of Bias Assessment (RoB 2). We conducted random-effects meta-analysis when appropriate. The primary outcomes included urinary symptoms score, quality of life, and adverse events. The certainty of the evidence was rated using GRADE. RESULTS: We included 27 trials with 4,853 participants. S. repens results in little to no difference in urinary symptoms, quality of life, and adverse events at short- and long-term follow-up. S. repens combined with other phytotherapy may slightly reduce urinary symptoms at short-term follow-up, but the results are uncertain. The results on quality of life and adverse events are also very uncertain. CONCLUSIONS: S. repens alone may result in no clinical benefits for men with LUTS. There is greater uncertainty in the effects of S. repens in combination with other phytotherapy.
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Sintomas do Trato Urinário Inferior/tratamento farmacológico , Sintomas do Trato Urinário Inferior/etiologia , Fitoterapia , Hiperplasia Prostática/complicações , Serenoa , Humanos , MasculinoRESUMO
OBJECTIVE: To assess the effects of pharmacological therapies for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). PATIENTS AND METHODS: We performed a comprehensive search using multiple databases, trial registries, grey literature and conference proceedings with no restrictions on the language of publication or publication status. The date of the latest search of all databases was July 2019. We included randomised controlled trials. Inclusion criteria were men with a diagnosis of CP/CPPS. We included all available pharmacological interventions. Two review authors independently classified studies and abstracted data from the included studies, performed statistical analyses and rated quality of evidence according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods. The primary outcomes were prostatitis symptoms and adverse events. The secondary outcomes were sexual dysfunction, urinary symptoms, quality of life, anxiety and depression. RESULTS: We included 99 unique studies in 9119 men with CP/CPPS, with assessments of 16 types of pharmacological interventions. Most of our comparisons included short-term follow-up information. The median age of the participants was 38 years. Most studies did not specify their funding sources; 21 studies reported funding from pharmaceutical companies. We found low- to very low-quality evidence that α-blockers may reduce prostatitis symptoms based on a reduction in National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) scores of >2 (but <8) with an increased incidence of minor adverse events such as dizziness and hypotension. Moderate- to low-quality evidence indicates that 5α-reductase inhibitors, antibiotics, anti-inflammatories, and phytotherapy probably cause a small decrease in prostatitis symptoms and may not be associated with a greater incidence of adverse events. Intraprostatic botulinum toxin A (BTA) injection may cause a large reduction in prostatitis symptoms with procedure-related adverse events (haematuria), but pelvic floor muscle BTA injection may not have the same effects (low-quality evidence). Allopurinol may also be ineffective for reducing prostatitis symptoms (low-quality evidence). We assessed a wide range of interventions involving traditional Chinese medicine; low-quality evidence showed they may reduce prostatitis symptoms without an increased incidence in adverse events. Moderate- to high-quality evidence indicates that the following interventions may be ineffective for the reduction of prostatitis symptoms: anticholinergics, Escherichia coli lysate (OM-89), pentosan, and pregabalin. Low- to very low-quality evidence indicates that antidepressants and tanezumab may be ineffective for the reduction of prostatitis symptoms. Low-quality evidence indicates that mepartricin and phosphodiesterase inhibitors may reduce prostatitis symptoms, without an increased incidence in adverse events. CONCLUSIONS: Based on the findings of low- to very low-quality evidence, this review found that some pharmacological interventions such as α-blockers may reduce prostatitis symptoms with an increased incidence of minor adverse events such as dizziness and hypotension. Other interventions may cause a reduction in prostatitis symptoms without an increased incidence of adverse events while others were found to be ineffective.
Assuntos
Prostatite/tratamento farmacológico , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
OBJECTIVE: To assess the effects of non-pharmacological therapies for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). PATIENTS AND METHODS: We performed a comprehensive search using multiple databases, trial registries, grey literature and conference proceedings with no restrictions on the language of publication or publication status. The date of the latest search of all databases was August 2017. We included randomized controlled trials in men with a diagnosis of CP/CPPS. We included all available non-pharmacological interventions. Two review authors independently classified studies and abstracted data from the included studies, performed statistical analyses and rated quality of evidence (QoE) according to the Grading of Recommendations Assessment, Development and Evaluation methods. The primary outcomes were prostatitis symptoms and adverse events. The secondary outcomes were sexual dysfunction, urinary symptoms, quality of life, anxiety and depression. RESULTS: We included 38 unique studies in 3290 men with CP/CPPS across 23 comparisons, reporting outcomes mostly at short-term follow-up. Our analysis showed that acupuncture probably leads to clinically meaningful reduction in prostatitis symptoms compared with a sham procedure (mean difference [MD] in total National Institutes of Health - Chronic Prostatitis Symptom Index [NIH-CPSI] score -5.79, 95% confidence interval [CI] -7.32 to -4.26, moderate QoE). Acupuncture may result in little or no difference in adverse events (low QoE). Acupuncture may also lead to a clinically meaningful reduction in prostatitis symptoms compared with standard medical therapy (MD -6.05, 95% CI -7.87 to -4.24, two studies, 78 participants, low QoE). Lifestyle modifications may be associated with a reduction in prostatitis symptoms compared with control (risk ratio for improvement in NIH-CPSI scores 3.90, 95% CI 2.20 to 6.92, very low QoE), but we found no information regarding adverse events. A physical activity programme may cause a small reduction in prostatitis symptoms compared with control (NIH-CPSI score MD -2.50, 95% CI -4.69 to -0.31, low QoE), but we found no information regarding adverse events. It was uncertain whether prostatic massage reduces or increases prostatitis symptoms compared with control (very low QoE) and we found no information regarding adverse events. Extracorporeal shockwave therapy reduces prostatitis symptoms compared with control (NIH-CPSI score MD -6.18, 95% CI -7.46 to -4.89, high QoE), but these results may not be sustained at medium-term follow-up (low QoE). This treatment may not be associated with a greater incidence of adverse events (low QoE). Transrectal thermotherapy, alone or in combination with medical therapy, may decrease prostatitis symptoms slightly when compared with medical therapy alone (NIH-CPSI score MD -2.50, 95% CI -3.82 to -1.18, low QoE). One included study reported that participants may experience transient adverse events. CONCLUSIONS: Based on the findings with moderate to high QoE, this review found that some non-pharmacological interventions, such as acupuncture and extracorporeal shockwave therapy, are likely to result in a decrease in prostatitis symptoms and may not be associated with a greater incidence of adverse events. The QoE for most other comparisons was predominantly low. Future clinical trials should include a full report of their methods, including adequate masking, consistent assessment of all patient-important outcomes including potential treatment-related adverse events and appropriate sample sizes.