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1.
BJU Int ; 117(6): 923-9, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-26477826

RESUMO

OBJECTIVE: To assess the safety and feasibility of aquablation in a first-in-man study. Aquablation is a novel minimally invasive water ablation therapy combining image guidance and robotics (AquaBeam(®) ) for the targeted and heat-free removal of prostatic tissue in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: A prospective, non-randomised, single-centre trial in men aged 50-80 years with moderate-to-severe LUTS was conducted. Under real-time image-based ultrasonic guidance, AquaBeam technology enables surgical planning and mapping, and leads to a controlled heat-free resection of the prostate using a high-velocity saline stream. Patients were evaluated at 1, 3, and 6 months after aquablation. RESULTS: In all, 15 patients were treated with aquablation under general anaesthesia. The mean (range) age was 73 (59-86) years and prostate size was 54 (27-85) mL. A substantial median lobe was present in six of the 15 patients. The mean International Prostate Symptom Score (IPSS) was 23 and the maximum urinary flow rate (Qmax ) was 8.4 mL/s at baseline. The mean procedural time was 48 min with a mean aquablation treatment time of 8 min. All procedures were technically successful with no serious or unexpected adverse events (AEs). All but one patient had removal of catheter on day 1, and most of the patients were discharged on the first postoperative day. No patient required a blood transfusion, and postoperative sodium changes were negligible. There were no serious 30-day AEs. One patient underwent a second aquablation treatment within 90 days of the first procedure. The mean IPSS score statistically improved from 23.1 at baseline to 8.6 at 6 months (P < 0.001) and the Qmax increased from 8.6 mL/s at baseline to 18.6 mL/s at the 6-month follow-up (P < 0.001). At 6 months, the mean detrusor pressure at Qmax decreased to 45 cmH2 0 from 66 cmH2 0 at baseline (P < 0.05), and the mean prostate size was reduced to 36 mL, a 31% reduction in size vs baseline (P < 0.001). No cases of urinary incontinence or erectile dysfunction were reported. CONCLUSIONS: These preliminary results from this initial study show aquablation of the prostate is technically feasible with a safety profile comparable to other BPH technologies. The combination of surgical mapping by the operating surgeon and the high-velocity saline provides a promising technique delivering a conformal, quantifiable, and standardised heat-free ablation of the prostate. Advantages of this technique include reduction in resection time compared with other endoscopic methods, as well as the potential to preserve sexual function.


Assuntos
Sintomas do Trato Urinário Inferior/cirurgia , Próstata/patologia , Hiperplasia Prostática/cirurgia , Procedimentos Cirúrgicos Robóticos/métodos , Ressecção Transuretral da Próstata/métodos , Obstrução do Colo da Bexiga Urinária/cirurgia , Água , Idoso , Idoso de 80 Anos ou mais , Estudos de Viabilidade , Humanos , Sintomas do Trato Urinário Inferior/patologia , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos , Nova Zelândia , Estudos Prospectivos , Hiperplasia Prostática/patologia , Procedimentos Cirúrgicos Robóticos/instrumentação , Ressecção Transuretral da Próstata/instrumentação , Resultado do Tratamento
2.
BJU Int ; 112 Suppl 2: 69-73, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24127679

RESUMO

OBJECTIVE: To compare the effectiveness, safety and cost of Tristel Fuse (chlorine dioxide) with Cidex OPA (ortho-phthaldehyde; 1,2-benzenedicarboxaldehyde) in an automated endoscopic reprocessor (AER) for high-level disinfection of flexible cystoscopes. PATIENTS AND METHODS: A randomised single-blind study comparing the high-level disinfectants Tristel Fuse as a simple office-based soak and Cidex OPA using an AER was performed. Participants were 'blinded' to the agent used for disinfection of the flexible cystoscopes. All patients had negative mid-stream urine at baseline, (MSU) no symptoms suggestive of urinary tract infection (UTI) on the day of investigation, no recent antibiotic use or current indwelling urinary catheter. Patients who underwent cystoscopic biopsy during the procedure were excluded. A urine analysis was done before and 3-5 days after cystoscopy and multiple equipment cultures were performed. The Urogenital Distress Inventory (UDI-6 + two questions from the 'long-form'), symptom and quality-of-life scores were assessed before and after cystoscopy as were ease-of-use assessments and a full cost analysis. RESULTS: In all, 180 of 465 screened participants were randomised 1:1 and the mean age was 72.1 years, 17% were females and 57% of procedures were performed for bladder tumour surveillance. The urine analysis was positive in 5.4% of patients in each group and 29% (Tristel) vs 20% (Cidex) of patients had urinary leukocyturia (p = ns) after cystoscopy. The turnover (minutes per cycle) was 7.5 (Tristel) vs 26.7 (Cidex). The per-procedure costs were $11.67 (American dollars) for Tristel Fuse and $21.82 for Cidex OPA with fixed costs of $4788 for Tristel Fuse and $60,514 for Cidex OPA. CONCLUSIONS: Tristel Fuse appears to be as effective and more cost-effective than Cidex OPA for high-level disinfection of flexible cystoscopes. This has significant cost implications for the office urologist.


Assuntos
Compostos Clorados/uso terapêutico , Cistoscópios/microbiologia , Desinfetantes/uso terapêutico , Desinfecção/métodos , Glutaral/uso terapêutico , Óxidos/uso terapêutico , o-Ftalaldeído/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Compostos Clorados/economia , Infecção Hospitalar/prevenção & controle , Desinfetantes/economia , Desinfecção/economia , Endoscopia , Feminino , Glutaral/economia , Humanos , Controle de Infecções/economia , Controle de Infecções/métodos , Masculino , Pessoa de Meia-Idade , Óxidos/economia , Método Simples-Cego , Resultado do Tratamento , o-Ftalaldeído/economia
3.
BJU Int ; 102(10): 1426-30; discussion 1430-1, 2008 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-18564132

RESUMO

OBJECTIVE: To evaluate the efficacy and safety of the ProACT (Uromedica, Inc., MN, USA) balloon device, an alternative for the surgical management of incontinence after prostatectomy. PATIENTS AND METHODS: The initial patients who received this device at our institution were evaluated, using urodynamics at baseline and at 6 months. Perioperative variables were recorded and pad usage, volume adjustments, an estimate of Incontinence Quality of Life (I-QoL) and adverse events were recorded at baseline, and 1, 3, 6, 12 and 24 months after surgery. RESULTS: In all, 37 patients were treated on this protocol between November 2001 and March 2005. Of these, 30 had had radical prostatectomy and seven holmium laser enucleation of the prostate. The mean (range) pad usage decreased from 2.81 (1-12) at baseline to 0.7 (0-4) pads at 24 months, and the I-QOL increased from 49.7 (4.5-77) to 81.3 (13.6-100) over the same period. At 24 months, 62% of 34 men were pad-free and 81% required one pad or less. Bilateral explantation was required in three patients (11%) for infection (one) and balloon migration (two). All other adverse events were mild and transient. CONCLUSIONS: The ProACT balloon device is an acceptable therapy for the surgical management of incontinence after prostatectomy.


Assuntos
Prostatectomia/efeitos adversos , Neoplasias da Próstata/cirurgia , Incontinência Urinária/terapia , Esfíncter Urinário Artificial , Idoso , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Incontinência Urinária/economia , Incontinência Urinária/etiologia , Esfíncter Urinário Artificial/economia , Esfíncter Urinário Artificial/normas , Urodinâmica
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