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Pelvic floor muscle training (PFMT) and the use of duloxetine (Cymbalta) may not be the best options for recovering urinary continence after robotic-assisted radical prostatectomy, according to the randomized IMPROVE trial.

Of patients who received no treatment at all, 53% recovered urinary continence 6 months after surgery compared with 35% of patients in the PFMT arm (P=0.07) and 39% of patients in the duloxetine arm (P=0.2). A fourth arm combining PFMT and duloxetine had even poorer results, with just 27% of those patients achieving urinary continence at 6 months (P=0.009), reported Rafael Sanchez-Salas, MD, of McGill University in Montreal, during a late-breaking abstract session at the American Urological Association virtual annual meeting.

Among the patients who achieved urinary continence recovery, there was no difference in the time to recovery between the four arms, he added.

Of note, neurovascular bundle preservation was the only factor associated with urinary continence recovery in the study (OR 3.5, interquartile range 1.2-10.3, P=0.02), he said.

"Most people talk about how nerve-sparing robotic prostatectomy can help preserve sexual function," Ash Tewari, MD, of the Icahn School of Medicine at Mount Sinai in New York City, told 番茄社区app. "The important finding of this study is that it is also important for improving urinary continence outcomes as well."

"Both pelvic floor muscle training and duloxetine have shown benefits in improving post-radical prostatectomy urinary incontinence, but this is mostly the result of retrospective series," Sanchez-Salas noted. The objective here was to assess the efficacy of PFMT and duloxetine in continence recovery after robotic-assisted radical prostatectomy in a prospective randomized controlled trial.

From 2015 to 2018, the IMPROVE study evaluated 240 patients with organ-confined prostate cancer who had urinary incontinence after surgery. They were randomized to four arms of 60 patients each: one with no treatment (control arm), one with duloxetine alone (60 mg at bedtime nightly for 3 months), one with PFMT alone (consisting of pelvic muscle contractions with biofeedback weekly for 3 months), and one combining PFMT with duloxetine.

The primary endpoint of the study was continence rates at 6 months, defined as no leakage of urine during 3 consecutive days on the 24-hour pad test. Secondary endpoints included urinary symptoms and quality of life, as assessed by a visual analog scale (VAS), the International Prostate Symptom Score (IPSS), and the King's Health Questionnaire.

Of the patients in the study, 89% completed a year of follow-up. Among the patients in the duloxetine arms, 58% had properly taken the drug, while 38% of patients in the PFMT arms performed at least 10 weeks of training.

An evaluation of symptoms using the IPSS showed that a greater proportion of patients in the treatment arms had moderate to severe urinary symptoms: 30% in the duloxetine alone arm, 27% in the PFMT arm, and 24% in the combination arm compared with 11% in the control arm.

As for quality of life as assessed with the VAS, 17% of patients in the control group reported being uncomfortable or worse compared with 45%, 44%, and 38% of patients in the duloxetine, PFMT, and combined arms, respectively.

"Based on our results we do not recommend routinely indicating these interventions for patients after robotic radical prostatectomy," Sanchez-Salas concluded. "Neurovascular bundle preservation was the only factor found to be associated with continence recovery, and we go back to the idea of the importance of a clean and precise surgical intervention to improve functional outcomes."

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