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BACKGROUND: No clear recommendations are available on whether retrograde intrarenal surgery (RIRS) via flexible ureterorenoscopy or shockwave lithotripsy (SWL) should be preferred for kidney stones ≤2 cm, except for lower-pole stones. OBJECTIVE: To compare outcomes between RIRS and SWL. DESIGN, SETTING, AND PARTICIPANTS: This was a single-center randomized controlled trial from March 2015 to May 2018. Patients with a single 6-20-mm kidney stone were enrolled (NCT02645058). INTERVENTION: Patients were randomized to RIRS or SWL. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the single-procedure stone-free rate (SFR) at 1 mo. Two levels of success were set: fragments ≤4 mm (SFR-4) and no residual fragments (SFR-0). Secondary endpoints were the SFR at 6 mo and 1 yr and rates of complications and further treatments. RESULTS AND LIMITATIONS: A total of 138 patients underwent treatment (70 RIRS vs 68 SWL). In comparison to SWL, RIRS SFR results were higher at 1 mo (SFR-4 70.0% vs 45.6%; p = 0.004; SFR-0 50.0% vs 26.5%; p = 0.004) and 6 mo (SFR-4 79.7% vs 63.6%; p = 0.038; SFR-0 59.4% vs 40.9%; p = 0.032). There was no difference in SFR measures between the groups at 1 yr (SFR-4 p = 0.322; SFR-0 p = 0.392). Overall complications were comparable (p = 0.207), but the complication rate for stones >10 mm was higher for the SWL group (p = 0.021). The need for further treatment was comparable (p = 0.368). In terms of patient satisfaction, 86.8% and 77.1% of patients would choose SWL and RIRS again, respectively (p = 0.24). CONCLUSIONS: RIRS achieved better SFRs in comparison to SWL at 1 and 6 mo, but not at 1 yr. The RIRS complication rate was lower for stones >10 mm. SWL remains a viable alternative, especially for 6-10-mm stones, providing comparable results to RIRS in the long term. PATIENT SUMMARY: We compared outcomes for the treatment of kidney stones ≤2 cm with two techniques: flexible ureteroscopy, in which a flexible telescope is passed through the urethra and bladder to reach the ureter between the bladder and kidney; and shockwave lithotripsy, in which shockwaves are applied to the skin over the location of the kidney stone. Ureteroscopy achieved better stone-free results at 1 and 6 months, but not at 1 year.
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Cálculos Renais , Humanos , Cálculos Renais/cirurgiaRESUMO
OBJECTIVE: To compare stent-related symptoms (SRS) of loop-tail (LT) and conventional double J (DJ) stents after uncomplicated flexible ureterorenoscopy (fURS), in a prospective randomised controlled single-blind parallel-group study. PATIENTS AND METHODS: Patients undergoing fURS were randomised into two groups: the LT Group received LT stents (Polaris™ Loop) and the DJ Group received conventional DJ stents (Vortek® ). The stent was removed after 4 weeks. The Ureteric Stent Symptom Questionnaire (USSQ) was administered at 2 days, 4 and 8 weeks (baseline evaluation) after stent insertion. The primary endpoint was to compare the Urinary Symptom Index Score of the LT vs DJ groups at 4 weeks after stent insertion. The secondary endpoints were to compare the USSQ domains' subscores at 2 days and 4 weeks after stent insertion, USSQ single answers at 4 weeks, and the 4-week USSQ domains' subscores adjusted for baseline. RESULTS: A total of 68 patients were randomised (34 LT and 34 DJ). The answers given at 4 weeks were not significantly different between the two groups for the Urinary Symptom Index Score (P = 0.982), Pain Index Score (P = 0.169), visual analogue scale (P = 0.276), and all the other domains of the USSQ. At 4 weeks, the single-answer analysis did not find any differences between the groups; the urinary symptoms were all comparable, as was the requirement for pain painkillers (P = 0.684) and pain during sex (P = 0.496). There were also no significant differences for every single domain score for the responses given at 2 days. The same applied to USSQ subscores at 4 weeks adjusted for the 8-week baseline results, which were also comparable. CONCLUSIONS: The study found no differences in terms of SRS between the LT and DJ groups, either at 2 days or 4 weeks after stent insertion, with or without baseline correction.
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Desenho de Equipamento/efeitos adversos , Dor/etiologia , Stents/efeitos adversos , Idoso , Analgésicos/uso terapêutico , Dispareunia/etiologia , Feminino , Humanos , Cálculos Renais/cirurgia , Masculino , Pessoa de Meia-Idade , Dor/tratamento farmacológico , Estudos Prospectivos , Comportamento Sexual , Método Simples-Cego , Inquéritos e Questionários , Avaliação de Sintomas , Fatores de Tempo , UreteroscopiaRESUMO
INTRODUCTION: Although spinal anesthesia (SA) may reduce postoperative morbidity, most urologists perform flexible ureterorenoscopy (fURS) under general anesthesia (GA). The objective of our study is to provide technical details, results, complications, and patients' satisfaction with fURS performed under exclusive SA. METHODS: We analyzed all consecutive fURS performed under SA to treat renal stones from March 2011 to February 2017. Details of technique, operative time, outcomes, need for further treatments, complications, and patients' satisfaction were evaluated. RESULTS: Two hundred thirty-four fURS under SA were considered. SA was performed through L2-L3 vertebral interspace in 64.1%. Patients were discharged the same day of surgery. Mean stone burden was 13.5 ± 6.6 mm and mean operative time 76.9 ± 34.6 min. Single-procedure SFR was 69.7%. Further treatments were performed in 22.8%. 96.6% had no anesthesia-related complications. No Clavien-Dindo grade ≥ IIIb complications were noticed. 99.6% of patients were satisfied with SA. No cases of conversion from SA to GA occurred. CONCLUSION: fURS can be performed safely and efficiently under SA, taking into account a few details of the technique. Patients' satisfaction with SA is very high, and complications are rare. Although SA is usually adopted in unfit patients for GA, it may be considered as a viable alternative in fit patients.
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Raquianestesia , Cálculos Renais , Raquianestesia/efeitos adversos , Feminino , Humanos , Cálculos Renais/etiologia , Cálculos Renais/cirurgia , Masculino , Satisfação do Paciente , Estudos Retrospectivos , Resultado do Tratamento , Ureteroscopia/efeitos adversos , Ureteroscopia/métodosRESUMO
BACKGROUND: Double J (DJ) ureteral stents are commonly inserted after ureteroscopy (URS) procedures for stone treatment. However, stent-related symptoms are still a major issue. OBJECTIVE: To determine whether a commercially available pigtail suture stent (PSS) can reduce stent-related symptoms compared to a conventional DJ stent after uncomplicated URS. DESIGN SETTING AND PARTICIPANTS: We designed a randomized, single-blind, parallel-group trial from January to November 2020. The inclusion criteria were stone-free URS without intraprocedural complications. Patients with distal ureteral stones were excluded. INTERVENTION: Insertion of a PSS or DJ stent after URS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the Urinary Symptom Index score on the Ureteral Stent Symptoms Questionnaire (USSQ) 2 wk after URS. Secondary endpoints were USSQ domain scores and responses to individual USSQ questions at 2 d and 2 wk after surgery. RESULTS AND LIMITATIONS: A total of 78 patients were randomized and treated according to protocol. The Urinary Symptom Index score (pâ¯=â¯0.004), overall Visual Analogue Scale (VAS) score (pâ¯=â¯0.022), and the percentage of patients complaining of pain (63.9% vs 86.1%, pâ¯=â¯0.029) were significantly in favor of PSS at both 2 d and 2 wk after URS. At 2 d, the VAS score among patients with pain (pâ¯=â¯0.025) and the General Health Index score (pâ¯=â¯0.036) were significantly better in the PSS group. No severe complications occurred in either group. Study limitations are the exclusion of patients with distal ureteral stones and the limited sample size. CONCLUSIONS: PSS significantly reduced stent-related symptoms after URS, in particular urinary symptoms and pain, compared to conventional DJ stents, and showed a good safety profile. PATIENT SUMMARY: Stents are hollow tubes placed in the passage between the kidney and the bladder (ureter). The standard stent has two coiled ends (double J stent) to keep it in place in both the kidney and the bladder. We tested a commercial stent with two strings at the bladder end (pigtail suture stent) after procedures to remove stones from the upper urinary tract and found that it caused less stent-related symptoms compared to a double J stent.This trial is registered at Clinicaltrials.gov as NCT03344120.
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OBJECTIVES: To describe first clinical results in term of safety, complications and short term efficacy of temporary placement of UVENTA urethral stent in the treatment of urethral and bladder neck strictures. METHODS: UVENTA urethral stent (Taewoong Medical) is a temporary self expandable covered metallic stent. Anti-migration system and different radial force distribution are the two main innovations. This is a retrospective evaluation of UVENTA stent temporary placements for urethral diseases in two urological Centers. RESULTS: 15 patients underwent UVENTA stent placement between 2016 and 2018. Stent placement was easy and quick in all cases. Considering indwelling period: one patient reported urethral pain related to the stent in the first month, three patients had urinary infection treated with antibiotics; temporary stress incontinence was noted in 21% of bulbar-membranous stents; stent migrations was noted in 3 out of 4 bladder neck cases whereas no bulbar-membranous stents migrated. At removal no significant incrustation, stone or tissue ingrowth were noted, as well as new proximal or distal strictures. Stent removal was uncomplicated in all cases. Median follow up is 9.5 months (6-24). Considering strictures overall success rate is 73% (11/15): 82% for bulbar urethra (9/11) and 50% for bladder neck (2/4). CONCLUSIONS: UVENTA urethral stent showed a satisfying safety profile with few and low grade complications. Absence of migration and damage on healthy mucosa are main achievements. Further cases are needed to confirm these results and to really explore its efficacy.
OBJETIVOS: Describir los primeros resultados clínicos en términos de seguridad, complicaciones y eficacia a corto plazo de la colocación temporal de stent uretral UVENTA en el tratamiento de estenosis de uretra y de cuello vesical.MÉTODOS: El stent uretral UVENTA (Taewoong Medical) es un stent metálico temporal autoexpandible. Las dos principales innovaciones son el sistema antimigración y la distribución de la fuerza radial. Esta es una evaluación retrospectiva de la colocación de UVENTA en enfermedades uretrales en dos centros urológicos. RESULTADOS: 15 pacientes recibieron UVENTA entre 2016 y 2018. La colocación del stent fue fácil y rápida en todos los casos. Teniendo en cuenta el periodo de catéter: un paciente describió dolor uretral relacionado con el stent en el primer mes, 3 pacientes tuvieron infección urinaria tratada con antibióticos; incontinencia urinaria de estrés en el 21% de pacientes con stent en uretra bulbomembranosa; la migración de stents se demostró en 3 de 4 casos con estenosis de cuello vesical, mientras, ningún caso de uretra bulbomembranosa migro. Al quitar el stent, no se observó incrustación significativa, litiasis o tejido en crecimiento, así como nuevas estenosis distales o proximales. La retirada del stent no fue complicada en la mayoría de casos. La mediana de seguimiento fue de 9,5 meses (6-24). Considerando la tasa de éxito en global fue de 73% (11/15): 82% para uretra bulbar (9/11) y 50% para cuello vesical (2/4). CONCLUSIONES: El stent uretral UVENTA demostró un perfil de seguridad satisfactorio con mínimas complicaciones. La ausencia de migración o daño de la mucosa sana son las principales virtudes. Son necesarios más casos para confirmar estos resultados y explorar su eficacia.
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Stents , Uretra , Remoção de Dispositivo , Humanos , Masculino , Estudos Retrospectivos , Uretra/cirurgiaRESUMO
PURPOSE: To evaluate in details the actual extent of double-J stent-related symptoms after semirigid (URS) and flexible (RIRS) ureteroscopy using a validated questionnaire. METHODS: We asked to complete the Ureteric Stent Symptoms Questionnaire (USSQ) to all stone patients undergoing URS or RIRS with stent placement from 2010 to 2015. Stent-related symptoms' prevalence, severity, and impact on daily life were analyzed using descriptive statistics and five-order Likert scales. Subgroups analyses were performed. RESULTS: 232 patients completed the USSQ. Stents had a deep impact on urinary symptoms (daily frequency ≥ 1 per hour 59.1%, ≥ 1 nocturnal micturition 90.1%, urgency 86.6%, burning 82.3%) that represented a problem for 88.4% of patients. 83.2% complained of pain, mostly in the kidney (67.9%) or in the bladder area (31.3%), particularly during physical activity (72.9%) and micturition (77.0%). Pain interfered with everyday life in 92.2%. General health, working, and sexual activity were also affected. 62.0% of patients would be dissatisfied (51.6% unhappy or terrible) if further ureteral stenting was proposed in future. Younger patients and females were more affected. Limitations include observational design and lack of baseline evaluation. CONCLUSIONS: Ureteral stents are responsible for significant urinary symptoms and pain after semirigid and flexible ureteroscopy. They also considerably affect general health, working and sexual activity. Urologists should consider it carefully before stenting, inform patients about stent-related symptoms, and minimize stent indwelling time.
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Complicações Pós-Operatórias/etiologia , Stents/efeitos adversos , Cálculos Ureterais/cirurgia , Ureteroscopia/efeitos adversos , Ureteroscopia/instrumentação , Transtornos Urinários/etiologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico , Estudos Prospectivos , Inquéritos e Questionários , Avaliação de Sintomas , Transtornos Urinários/diagnósticoRESUMO
BACKGROUND: Retrograde intra-renal surgery (RIRS) has become increasingly common and is mainly performed under general anesthesia (GA). There are no specific papers about RIRS performed under spinal anesthesia (SA). Our objective was to evaluate feasibility and results of RIRS performed under SA. METHODS: We analyzed all consecutive RIRS performed for stones in day surgery from March 2008 to September 2012. Single procedures outcomes of RIRS performed under SA were evaluated with US and KUB X-ray at 2 weeks. Further treatments, operative time and complications were also evaluated. Outcomes of RIRS performed under SA and GA were compared. Difference between groups was statistically analyzed. Significance level was set at P<0.05. RESULTS: One hundred thirty-nine RIRS under SA and 47 under GA were considered. Mean stone burden was 14±6 mm. No case of conversion from SA to GA occurred. Stone-free rate (SFR) level 4U of RIRS under SA and under GA were respectively 63.6% and 48.6%, SFR level 0U 24.5% and 25.7%, CIRF 39.1% and 22.9%. Further treatments were performed respectively in 20.8% and in 23.4%. No anesthesia-related and Clavien-Dindo grade ≥3 complications occurred. No statistically significant difference was found in stone-free rates, CIRF and significant residual fragments rates, need for further procedures, operative time and complications between the two groups. CONCLUSIONS: RIRS under SA seems feasible and effective for renal stones in day surgery. Results seem equivalent to RIRS under GA. SA can be considered for RIRS as an alternative to GA.