AQUA: Anticholinergic Side Effects QUestionnAire
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Observational

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      antimuscarinics adherence is poor and anticholinergic drugs are often withdrawn few months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.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): validated questionnaire to assess side effects secondary to antimuscarinics treatment in neurogenic bladder
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.
      
Keywords: tool; side effects; questionnaire; neurogenic bladder