Clinical trial NCT04791111: AQUA: Anticholinergic Side Effects QUestionnAire
Official title: AQUA: A NEW QUESTIONNAIRE ASSESSING ANTICHOLINERGIC SIDE EFFECTS IN NEUROGENIC POPULATION (AQUA: Anticholinergic Side Effects QUestionnAire)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: tool
side effects
questionnaire
neurogenic bladder
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient suffering from OAB symptoms secondary to neurogenic condition and treated by antimuscarinic treatment.

Brief summary: Overactive bladder syndrome (OAB) is very frequent and increase with age. 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 However, antimuscarinics adherence is poor and anticholinergic drugs are often withdrawn few months after their introduction.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 questionnaires which evaluate side effects or constraints. 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.

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.

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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: reproductibilty of Anticholinergic side effects QuestionnAire (AQUA)
timeFrame: 1 day
measure: Acceptatbility of AQUA
timeFrame: 1 day
measure: Comprehension of AQUA
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: department of Neuro-Urology, Hôpital Tenon
Study officials:
affiliation: Sorbonne University, GRC 001, GREEN, APHP, Hopital Tenon, France
name: Gérard AMARENCO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: