Definición de continencia y factores pronósticos para la recuperación temprana de la continencia urinaria en la prostatectomía radical robótica con reconstrucción posterior del rabdoesfínter. Análisis post hoc de un ensayo clínico aleatorizado / Continence definition and prognostic factors for early urinary continence recovery in posterior rhabdosphincter reconstruction after robot-assisted radical prostatectomy. Post-hoc analysis of a randomised controlled trial

Introducción La incontinencia urinaria después de la prostatectomía radical es un efecto adverso con gran impacto en la calidad de vida. Actualmente no disponemos de medidas estandarizadas para su evaluación. La reconstrucción posterior del rabdoesfínter (RPR) puede mejorar la incontinencia urinaria precoz. Nuestro objetivo fue analizar diferentes definiciones y factores pronósticos de continencia urinaria precoz después de prostatectomía radical robótica (PRR).Materiales y métodos Realizamos un ensayo clínico aleatorizado (NCT03302169) incluyendo 152 pacientes con cáncer de próstata localizado sometidos a PRR y aleatorizados en anastomosis uretrovesical simple (grupo control) y RPR previa a la anastomosis (grupo RPR). La continencia urinaria se evaluó mediante cuestionarios específicos (EPIC-26 y ICIQ-SF), y la utilización de compresas (0-1 compresa y 0 compresas) a los 7, 15, 30, 90, 180 y 365 días tras la retirada de la sonda vesical. Se analizaron factores predictores para recuperación de continencia urinaria precoz.Resultados Se incluyeron 72 pacientes en el grupo control y 80 en el grupo RPR. Las características basales fueron similares entre grupos excepto el índice de masa corporal, mayor en el grupo RPR. La definición «0 compresas» fue la única que demostró beneficio de la RPR a los 30 días, con continencia del 33,8% en el grupo RPR y 18,1% en el grupo control, p=0,022, y a los 90 días, 58,8% y 43,1%, respectivamente, p=0,038. Los cuestionarios no mostraron diferencias entre grupos. La RPR fue el único factor predictor de continencia urinaria precoz.Conclusiones La RPR mejora las tasas de continencia urinaria precoz, pero la definición de continencia es determinante. El único factor predictor de continencia urinaria precoz fue la RPR (AU)

Introduction Urinary incontinence after radical prostatectomy (RP) is an adverse event with high impact on patient's quality of life. Nowadays there is no standardized method for urinary continence measurement. Posterior rhabdosphincter reconstruction (PRR) is a surgical step that can improve early urinary continence after RP. Our objective was to analyse different continence definitions and predictors of urinary continence recovery after robot-assisted RP (RARP).Materials and methods We conducted a double-blind, randomised controlled trial (NCT03302169) including 152 consecutive patients with localized prostate cancer subjected to RARP. Patients were randomised to single urethrovesical anastomosis (control arm) or PRR before urethrovesical anastomosis (PRR arm). Urinary continence was measured with the EPIC-26 and ICIQ-SF validated questionnaires, and pad use (0-1 pads and no pads), at 7, 15, 30, 90, 180 and 365 days after catheter removal. Prognostic factors for early urinary continence recovery were analysed.Results 72 patients were included in the control arm and 80 in the PRR arm. Baseline characteristics were similar between arms, except body mass index, which was higher in PRR arm. “No pad” was the only definition assessing the benefit of PRR at 30 days, 33.8% in PRR arm and 18.1% in control arm, p=0.022; and at 90 days, 58.8 and 43.1% respectively, p=0.038. Questionnaires did not detect differences in terms of continence recovery. PRR was the only predictor for early continence recovery, p=0.03.Conclusions PRR increased early urinary continence recovery after RARP. Continence definition was critical to assess benefit. The only predictive factor for early continence recovery was PRR (AU)

Continence definition and prognostic factors for early urinary continence recovery in posterior rhabdosphincter reconstruction after robot-assisted radical prostatectomy. Post-hoc analysis of a randomised controlled trial.

INTRODUCTION: Urinary incontinence after radical prostatectomy (RP) is an adverse event with high impact on patient's quality of life. Nowadays there is no standardized method for urinary continence measurement. Posterior rhabdosphincter reconstruction (PRR) is a surgical step that can improve early urinary continence after RP. Our objective was to analyse different continence definitions and predictors of urinary continence recovery after robot-assisted RP (RARP). MATERIAL AND METHODS: We conducted a double-blind, randomised controlled trial (NCT03302169) including 152 consecutive patients with localized prostate cancer subjected to RARP. Patients were randomised to single urethrovesical anastomosis (control arm) or PRR before urethrovesical anastomosis (PRR arm). Urinary continence was measured with the EPIC-26 and ICIQ-SF validated questionnaires, and pad use (0-1 pads and no pads), at 7, 15, 30, 90, 180 and 365 days after catheter removal. Prognostic factors for early urinary continence recovery were analysed. RESULTS: 72 patients were included in the control arm and 80 in the PRR arm. Baseline characteristics were similar between arms, except body mass index, which was higher in PRR arm. "No pad" was the only definition assessing the benefit of PRR at 30 days, 33.8% in PRR arm and 18.1% in control arm, p = 0.022; and at 90 days, 58.8 and 43.1% respectively, p = 0.038. Questionnaires did not detect differences in terms of continence recovery. PRR was the only predictor for early continence recovery, p = 0.03. CONCLUSIONS: PRR increased early urinary continence recovery after RARP. Continence definition was critical to assess benefit. The only predictive factor for early continence recovery was PRR.

A Randomised Controlled Trial to Assess the Benefit of Posterior Rhabdosphincter Reconstruction in Early Urinary Continence Recovery after Robot-assisted Radical Prostatectomy.

Posterior rhabdosphincter reconstruction (PRR) has been proposed to improve early urinary continence (UC) recovery after radical prostatectomy (RP). In order to generate level 1b evidence, we designed a double-blind randomised controlled trial powered to detect a 20% increase in early UC recovery after robot-assisted RP (RARP). A group of 153 patients with cT1c-3a N0M0 prostate cancer were randomised (73 to control arm and 80 to PRR arm) and 152 completed 12-mo follow-up. For UC defined as no pad use, the recovery hazard ratio at 1-mo follow-up was 2.312 (95% confidence interval [CI] 1.081-4.937; p = 0.030). UC recovery was observed in 33.8% of patients in the PRR arm and 18.1% of patients in the control arm (p = 0.022). At 3-mo follow-up the corresponding rates were 58.8% and 43.1% (p = 0.038). The median time to UC recovery was 106 d (95% CI 73-139) in the control arm and 64 d (95% CI 39-89) in PRR arm (p = 0.897). No differences in pathological outcomes or early and late surgical complications were observed between the arms. We conclude that PRR is safe and increases early UC recovery after RARP. PATIENT SUMMARY: We investigated reconstruction of a muscular ring that controls the flow of urine, called the rhabdosphincter, after removal of the prostate in robot-assisted surgery. The procedure is safe and increases early recovery of urinary continence. This trial is registered at ClinicalTrials.gov as NCT03302169.

The position of urethrovesical anastomosis after robotic radical prostatectomy assessed by MRI predicts early functional recovery: A cohort analyses from a randomized clinical trial.

PURPOSE: Functional and anatomical changes associated with prostate removal coincide with alterations in pelvic structures. Posterior rhabdosphincter reconstruction was designed to improve urinary continence after radical prostatectomy. The aim of this study was to determine magnetic resonance anatomic predictors of urinary recovery after radical prostatectomy, and to assess their relation to the type of reconstruction. MATERIAL AND METHODS: Forty patients were randomly selected from a trial (NCT03302169). Two independent radiologists determined the situation of the anastomosis in the pelvis according to MRI performed a month after the radical prostatectomy: vertical situation assessed as the distance to the line coccyx-inferior pubic margin (ACPv) and anteroposterior situation as the distance from the pubis (Distance A), and from the coccyx (Distance B). RESULTS: The Pearson correlation of ACPv, Distance A, and B between readers were 0.975, 0.940, and 0.711, p < 0.001. Patients with the reconstruction presented more cephalic situation of the anastomosis (higher ACPv) than patients with standard reconstruction technique. A multivariate analysis was performed including age, BMI, prostate volume, PRRS, and the MRI parameters. ACPv and Distance B were the only two independent predictors of no need for any urinary protection at 6 months after the surgery. CONCLUSIONS: This is the first study that suggests positional differences according to the type of reconstruction after radical prostatectomy related to early urinary recovery. Magnetic resonance measurements to determine anastomosis positioning are reliable and have a strong correlation between readers. Anatomic MRI features are independent predictors of urinary recovery after robotic radical prostatectomy.

Posterior musculofascial reconstruction after radical prostatectomy: an updated systematic review and a meta-analysis.

To evaluate the influence of posterior musculofascial plate reconstruction (PR) on early return of continence after radical prostatectomy (RP); an updated systematic review of the literature. A systematic review of the literature was performed in June 2015, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and searching Medline, Embase, Scopus and Web of Science databases. We searched the terms posterior reconstruction prostatectomy, double layer anastomosis prostatectomy across the 'Title' and 'Abstract' fields of the records, with the following limits: humans, gender (male), and language (English). The authors reviewed the records to identify studies comparing cohorts of patients who underwent RP with or without restoration of the posterior aspect of the rhabdosphincter. A meta-analysis of the risk ratios estimated using data from the selected studies was performed. In all, 21 studies were identified, including three randomised controlled trials. The overall analysis of comparative studies showed that PR improved early continence recovery at 3-7, 30, and 90 days after catheter removal, while the continence rate at 180 days was statistically but not clinically affected. Statistically significantly lower anastomotic leakage rates were described after PR. There were no significant differences for positive surgical margins rates or for complications such as acute urinary retention and bladder neck stricture. The analysis confirms the benefits at 30 days after catheter removal already discussed in the review published in 2012, but also shows a significant advantage in terms of urinary continence recovery in the first 90 days. A multicentre prospective randomised controlled trial is currently being conducted in several institutions around the world to better assess the effectiveness of PR in facilitating an earlier recovery of postoperative urinary continence.