Assessing the efficacy of pelvic floor muscle training and duloxetine on urinary continence recovery following radical prostatectomy: A randomized clinical trial

• Published in: The Prostate Vol. 84; no. 2; pp. 158 - 165
• Main Authors: Sanchez-Salas, Rafael, Tourinho-Barbosa, Rafael, Sivaraman, Arjun, Borges, Rafael Castilho, Candela, Luigi, Cathala, Nathalie, Mombet, Annick, Marra, Giancarlo, Sanchez, Lara Rodriguez, Boumezrag, Chahrazad Bey, Lanz, Camille, Macek, Petr, Korkes, Fernando, Cathelineau, Xavier
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01-02-2024
• Subjects: Arm; Biofeedback; Cancer surgery; Duloxetine; Duloxetine Hydrochloride - therapeutic use; Electromyography; Feedback; Humans; Male; Patients; Pelvic Floor; Pelvis; Preservation; Prostate cancer; Prostatectomy; Prostatectomy - adverse effects; Quality of Life; Treatment Outcome; Urinary incontinence; Urinary Incontinence - etiology; Urinary Incontinence - therapy; Urological surgery; pelvic floor muscle; prostate cancer; quality of life; urinary incontinence; robot-assisted laparoscopic radical prostatectomy
• ISSN: 0270-4137; 1097-0045
• DOI: 10.1002/pros.24634

Urinary incontinence (UI) can negatively impact quality of life (QoL) after robot-assisted radical prostatectomy (RARP). Pelvic floor muscle training (PFMT) and duloxetine are used to manage post-RARP UI, but their efficacy remains uncertain. We aimed to investigate the efficacy of PFMT and duloxetine in promoting urinary continence recovery (UCR) after RARP.
A randomized controlled trial involving patients with urine leakage after RARP from May 2015 to February 2018. Patients were randomized into 1 of 4 arms: (1) PFMT-biofeedback, (2) duloxetine, (3) combined PFMT-biofeedback and duloxetine, (4) control arm. PFMT consisted of pelvic muscle exercises conducted with electromyographic feedback weekly, for 3 months. Oral duloxetine was administered at bedtime for 3 months. The primary outcome was prevalence of continence at 6 months, defined as using ≤1 security pad. Urinary symptoms and QoL were assessed by using a visual analogue scale, and validated questionnaires.
From the 240 patients included in the trial, 89% of patients completed 1 year of follow-up. Treatment compliance was observed in 88% (92/105) of patients receiving duloxetine, and in 97% (104/107) of patients scheduled to PFMT-biofeedback sessions. In the control group 96% of patients had achieved continence at 6 months, compared with 90% (p = 0.3) in the PMFT-biofeedback, 73% (p = 0.008) in the duloxetine, and 69% (p = 0.003) in the combined treatment arm. At 6 months, QoL was classified as uncomfortable or worse in 17% of patients in the control group, compared with 44% (p = 0.01), 45% (p = 0.008), and 34% (p = 0.07), respectively. Complete preservation of neurovascular bundles (NVB) (OR: 2.95; p = 0.048) was the only perioperative intervention found to improve early UCR.
PFMT-biofeedback and duloxetine demonstrated limited impact in improving UCR after RP. Diligent NVB preservation, along with preoperative patient and disease characteristics, are the primary determinants for early UCR.