AQUA: A NEW QUESTIONNAIRE ASSESSING ANTICHOLINERGIC SIDE EFFECTS IN NEUROGENIC POPULATION (AQUA: Anticholinergic Side Effects QUestionnAire)
AQUA: A NEW QUESTIONNAIRE ASSESSING ANTICHOLINERGIC SIDE EFFECTS IN NEUROGENIC POPULATION (AQUA: Anticholinergic Side Effects QUestionnAire)
Lower Urinary tract symptoms (LUTS) are widespread in the general population and their
 prevalence is expected to increase in the coming years as the elderly population increases.
 Indeed, overactive bladder syndrome (OAB) is very frequent and increase with age. OAB has
 numerous and various etiologies and can be caused by urologic, metabolic, neurogenic or
 autonomic dysfunction. Treatments for OAB depends on etiology but first line treatment often
 corresponds to lifestyle modification and antimuscarinics. Antimuscarinics allows improvement
 for OAB symptoms, quality of life and urodynamic parameters. However, antimuscarinics
 adherence is poor and anticholinergic drugs are often withdrawn few months after their
 introduction. This low adherence to antimuscarinics can be explained by side effects as dry
 mouth, blurred vision, constipation or cognitive impairment which are due to systemic
 anticholinergic effects since specificity and receptor affinity of bladder antimuscarinics
 are poor with a large distribution of acetylcholine receptors in all the body. Unfortunately,
 there is no or a few questionnaires which evaluate side effects or constraints, except for
 one published in 2019, but not specific for anticholinergics. This part of evaluation is
 poorly reported in medical literature, whereas it seems to be clear that side effects should
 be systematically evaluate and are in part responsible of treatment discontinuation. The
 objective of the study is to develop and validate a new questionnaire to assess side effects
 of antimuscarinic treatment in a patient with OAB.

 The study was conducted in a Neuro-urology Department of a University Hospital. To allow a
 full psychometric validation of the questionnaire, the study protocol included 3 steps:
 qualitative interviews, feasibility study and validation study. The inclusion criteria were
 to be aged > 18 years and to have OAB symptoms according to the ICS definition and secondary
 to a neurogenic dysfunction.

 First step of the study consisted in a review literature on Pubmed to explore the different
 side effects secondary to antimuscarinic treatment and do determine which tools were
 available. In addition, we conducted semi-structured interviews on 30 patients suffering from
 OAB.

 Feasibility Study For this feasibility study, 30 patients were included. They had to rate
 each item to evaluate comprehension, acceptation and pertinence with a three-points Likert
 scale from response "0: not at all or quite" to "2: perfectly".

 Validation study: 100 patients Content validity was assessed by the panel of experts.
 Internal consistency reliability was calculated using the α coefficient of Cronbach. Each
 response has been transformed in a numeric value to perform this test. Alpha coefficient of
 Cronbach was considered as very good if > 0.7.

 Test-retest reliability was tested using the intraclass correlation coefficient (ICC) which
 was significant over 0.7. The first questionnaire was filled at the end of the first
 consultation and patients had to answer a second questionnaire (filled at home) 7 days after
 the first consultation.

 Objective was to validate this questionnaire with good or very good psychometric properties.
 Primary outcome was Alpha coefficient of Cronbach and ICC ≥ 0,7.
Inclusion Criteria:

 -  OAB symptoms according to ICS definition

 -  neurogenic bladder

 -  antimuscarinic treatment

 Exclusion Criteria:

 -  Treatment change between first evaluation and second evaluation (Test retest validity)