(UroToday.com) The American Urologic Association (AUA) annual meeting included a late-breaking abstract session with a presentation by Dr. Rafael Sanchez-Salas discussing results of the IMPROVE trial assessing surgical technique in the context of recovery of urinary continence after radical prostatectomy. Post-radical prostatectomy urinary incontinence is not uncommon. Both pelvic floor muscle training and duloxetine have been shown to be effective in improving post-radical prostatectomy urinary incontinence in retrospective series. This trial aimed to assess the efficacy of pelvic floor muscle training and duloxetine in urinary continence recovery after robot-assisted radical prostatectomy.
This was a prospective, randomized controlled trial (NCT02367404) involving patients who experienced urinary incontinence after robot-assisted radical prostatectomy. Patients were randomized to 1 of 4 arms: (1) pelvic floor muscle training-biofeedback only, (2) duloxetine only, (3) combined pelvic floor muscle training-biofeedback and duloxetine, and (4) control group. The pelvic floor muscle training program consisted of pelvic muscle contraction exercises conducted with electromyographic feedback weekly, for 3 months. Patients in duloxetine arms were instructed to take oral duloxetine 60 mg at bedtime for 3 months. The primary endpoint was continence rate at 6 months, defined as no leakage of urine during 3 consecutive days on the 24-hour pad test. Urinary symptoms and quality of life were assessed by using a visual analog scale, the International Prostate Symptom Score questionnaire, and the King’s Health Questionnaire.
A total of 240 patients (60 in each arm) were included in the trial between 2015 and 2018. Overall, 89% of patients completed 1 year of follow-up. From the patients allocated to receive treatment, 58% (69 of 120) had properly taken duloxetine and 38% (46 of 120) performed at least 10 sessions of pelvic floor muscle training. In the control group 53% of patients have achieved continence at 6 months, compared with 35% (p = 0.07) in the pelvic floor muscle training-biofeedback arm, 39% (p = 0.2) in the duloxetine arm, and 27% (p = 0.009) in the combined treatment arm, without difference in time to urinary continence recovery:
Moderate to severe urinary symptoms (IPSS >= 8) were less frequent in the control group (11%) compared with treatment arms: 27% (p = 0.03), 30% (p = 0.01), 24% (p = 0.07), respectively. At 6 months, quality of life was qualified as uncomfortable or worse in 17% of patients in the control group, compared with 44% (p = 0.02), 45% (p = 0.01), and 38% (p = 0.06) in treatment arms, respectively. After accounting for other variables, neurovascular bundle preservation was the only factor found to be associated with urinary continence recovery (OR 3.5, IQR 1.2-10.3; p = 0.02).
Dr. Sanchez-Salas concluded his presentation of the IMPROVE trial with the following take-home messages:
- Pelvic floor muscle training-biofeedback and duloxetine do not improve urinary continence recovery after robot-assisted radical prostatectomy, and may have negative impact on quality of life
- These treatment modalities should not be routinely recommended to patients who have undergone robot-assisted radical prostatectomy
- Neurovascular bundle preservation was the only factor found to be associated with recovery of urinary continence
Presented by: Rafael Sanchez-Salas, MD, McGill University, Montreal, Quebec, Canada
Co-Authors: Arjun Sivaraman, Rafael Tourinho-Barbosa, Caio Pasquali, Luigi Candela, Giancarlo Marra, Lara Rodriguez-Sanchez , Nathalie Cathala, Annick Mombet, Chahrazad Bey Boumezrag, Petr Macek, Xavier Cathelineau
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2021 American Urological Association, (AUA) Annual Meeting, Fri, Sep 10, 2021 – Mon, Sep 13, 2021.