AQUA: Anticholinergic Side Effects QUestionnAire

NCT04791111 | Completed

• 1 other identifier: GREEN GRC-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 However, antimuscarinics adherence is poor and anticholinergic drugs are often withdrawn few months after their introduction.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

Conditions

Overactive Bladder

Keywords

tool; side effects; questionnaire; neurogenic bladder

Outcome Measures

Primary Outcomes (3)

• reproductibilty of Anticholinergic side effects QuestionnAire (AQUA)

  Patients were asked to answer a second time the questionnaire with a second evaluation at 14 days after the first one. The "intra-class correlation coefficient" (ICC) was used to detemrine if this evaluaiton could lead to similar result for each quesiton. An ICC\>0.70 was necessary to define reproductibility.

  1 day

• Acceptatbility of AQUA

  Each patient was asked to rate acceptatibilty of the questionnaire with a four-point liket scale (A: perfect, B : good, C: Average, D: bad) regarding acceptance of the questions

  1 day

• Comprehension of AQUA

  Each patient was asked to rate comprehension of the questionnaire with a four-point liket scale (A: perfect, B : good, C: Average, D: bad) regarding comprehension of the questions

  1 day

Interventions

Questionnaire OTHER

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient suffering from OAB symptoms secondary to neurogenic condition and treated by antimuscarinic treatment.

You may qualify if:

• OAB symptoms according to ICS definition
• neurogenic bladder
• antimuscarinic treatment

You may not qualify if:

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

Sponsors & Collaborators

• Pierre and Marie Curie University: lead

Study Sites (1)

department of Neuro-Urology, Hôpital Tenon

Paris, 70020, France

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Bladder, Neurogenic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gérard AMARENCO, MD, PhD

  Sorbonne University, GRC 001, GREEN, APHP, Hopital Tenon, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor, Head of neuro urology department, APHP, tenon Hospital, Paris, France

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: January 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-02

Locations

FR (1)