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.

KEYWORDS:

• Lower urinary tract symptoms
• Clinical care pathway
• Sacral neuromodulation
• Overactive bladder
• Quality Improvement

Author contributions

Lynn Ghijselings MD: First author. Protocol concept/ study design.

Dirk Van de Putte MD: Patient recruitment.

François Hervé MD: Patient recruitment.

An-Sofie Goessaert MD, PhD: Patient recruitment.

Dimitri Beeckman, PhD: Protocol concept. Critical revision.

Piet Pattyn MD, PhD: Patient recruitment.

Karel Everaert MD, PhD: Critical revision of the article, Approval of article. Patient recruitment. Protocol concept/study design.

Disclosure statement

The OptiLUTS chair was financially supported by Medtronic. Additionally grants from Astellas Pharma BeLux were obtained.