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AQUA: Anticholinergic Side Effects QUestionnAire

NCT04791111 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-03-04

No results posted yet for this study

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 However, antimuscarinics adherence is poor and anticholinergic drugs are often withdrawn few months after their introduction.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.

Conditions

Interventions

OTHER

Questionnaire

validated questionnaire to assess side effects secondary to antimuscarinics treatment in neurogenic bladder

Sponsors & Collaborators

  • Pierre and Marie Curie University

    lead OTHER

Principal Investigators

  • Gérard AMARENCO, MD, PhD · Sorbonne University, GRC 001, GREEN, APHP, Hopital Tenon, France

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-06-30
Completion
2021-08-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791111 on ClinicalTrials.gov