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

Author:

Sanchez‐Salas Rafael12,Tourinho‐Barbosa Rafael23ORCID,Sivaraman Arjun2,Borges Rafael Castilho23,Candela Luigi2,Cathala Nathalie2,Mombet Annick2,Marra Giancarlo2,Sanchez Lara Rodriguez2,Boumezrag Chahrazad Bey4,Lanz Camille2,Macek Petr2,Korkes Fernando3ORCID,Cathelineau Xavier2

Affiliation:

1. Department of Surgery, Division of Urology McGill University Montreal Canada

2. Department of Urology Institut Mutualiste Montsouris, Université Paris‐Descartes Paris France

3. Department of Urology Faculdade de Medicina do ABC (ABC Medical School) São Paulo Brazil

4. Department of Research Institut Mutualiste Montsouris, Université Paris‐Descartes Paris France

Abstract

AbstractBackgroundUrinary 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.MethodsA 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.ResultsFrom 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.ConclusionsPFMT‐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.

Publisher

Wiley

Subject

Urology,Oncology

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