The OptiLUTS trial: improving care for therapy-resistant symptoms of the pelvis in Belgium.

Abstract

Introduction/background: The management of therapy-resistant lower urinary tract symptoms (LUTS) and symptoms resulting from pelvic organ dysfunctions are subject to a high variability in the Belgian health-care centres. Practical guidelines and standardized patient clinical care pathways are often lacking and unadapted to the Belgian healthcare system.

Objectives: The OptiLUTS trial aims to improve the multidisciplinary care of therapy-resistant symptoms of the pelvis in the Belgian healthcare setting. Project A aims for the improvement of knowledge of 2nd line treatments for LUTS among general practitioners. In project B a treatment algorithm for the overactive bladder syndrome and non-obstructive urinary retention will be developed specifically for Belgium. In Project C a patient customized sacral neuromodulation (SNM) care pathway will be set up.

Methods: Part A: Explorative study among general practitioners by distribution of a  questionnaire. Part B: Review of existing guidelines and use of the Delphi method to obtain expert consensus. Part C: A single center comparative study to compare outcomes before and after implementation of the SNM care pathway. Patients scheduled for the first stage of Interstim therapy™ will be included (N=100). Primary endpoints are the sensitivity and specificity of a new pelvic symptom assessment tool, the conversion to implant and explantation rates.

Conclusion: There is a margin for improvement in the care process of patients with therapy-resistant symptoms of the pelvis in the Belgium healthcare system. In the OptiLUTs trial adapted guidelines and a clinical care pathway will be developed to standardize and increase the efficiency of care.

Trial registration: Approval for the trial by the Ethics Committee of the Ghent University hospital: EC/2018/0244.