Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04791111 |
| Other study ID # |
GREEN GRC-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
August 31, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Pierre and Marie Curie University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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antimuscarinics adherence is poor and anticholinergic drugs are often withdrawn few months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.
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.
