The effect of using a standard illustrated consent form on anxiety levels in the urodynamic investigation: a prospective clinical study

Ozkan O1, Guctas A1, Sahin B1, Sekerci C1, Onur R1, Cam K1, Tarcan T1

Research Type

Clinical

Abstract Category

Urodynamics

Abstract 141
Urodynamics
Scientific Podium Short Oral Session 8
Thursday 8th September 2022
15:35 - 15:42
Hall D
Urodynamics Equipment Quality of Life (QoL) Questionnaire Prospective Study Urodynamics Techniques
1. Marmara University School of Medicine, Department of Urology
Online
Presenter
O

Onur Can Ozkan

Links

Abstract

Hypothesis / aims of study
Urodynamic studies are frequently used minimally invasive procedures for the investigation of lower urinary system functions Also, considering the risk of infection associated with these invasive tests, some studies have reported considerable anxiety during the procedure (1-3). The aim of this prospective randomized study was to measure anxiety associated with the urodynamic studies and to investigate the role of using a simple illustrated information sheet before the urodynamic study in reducing anxiety levels. In addition, we aimed to develop a new specific questionnaire as the Urodynamics Quality of Life-Anxiety Form (UQL-AF) in this study.
Study design, materials and methods
A single-center prospective study, approved by the ethical committee, was performed at the urodynamics unit between the 1st of October, 2020 and the 1st of October, 2021. All subsequent patients between 18 and 80 years old who underwent urodynamic studies were included. Exclusion criteria involved a history of invasive procedures that can affect anxiety levels such as the previous history of urodynamic study, history of urethral catheterization, history of urological malignancy, previous surgery excluding circumcision, and history of gastrointestinal endoscopy. A regular consent form was signed by each patient who participated in this study before the urodynamic investigation. The patients were randomized into two groups by using a simple randomization method. The first group received a newly developed one-page illustrated information sheet attached to the regular consent form, while the second group took only the conventional consent form. All patients completed the "International Prostate Symptom Score" (IPSS) and "Marmara Overactive Bladder Questionnaire” (M-OBQ) forms. Both groups were also received the "Hospital Anxiety and Depression Scale" (HADS) to measure their anxiety levels before and 1 hour after the urodynamic study. In addition, the UQL-AF as a new original form was given to each patient in both groups. The results of these scales were compared.
Results
A total of 122 appropriate patients were randomized into two groups. The mean age of the patients was 46.56 years. Of all patients, 54.9% were male and 45.1% were female. There was no statistical difference in quantitative and categorical variables between both groups. Also, no difference was seen between both groups in terms of systemic diseases, urodynamic indications, results of both IPSS and M-OBQ. Significant anxiety (HADS anxiety score≥8) was detected in 50.9% of the patients before the urodynamic study in the whole group. Although the average HADS scores were not statistically significant in the baseline measurements before the procedure, they were lower in the first group that received illustrated sheet (p=0.756 for HADS anxiety score, p=0.786 for HADS depression score). Also, the number of patients with remarkable anxiety before the procedure was lower without statistical significance according to HADS values in the first group (p=0.717). The proportion of patients with severe HADS anxiety and depression scores decreased significantly in both groups after 1 hour of the procedure (for HADS anxiety score, p=0.0001 in group 1, p=0.001 in group 2). The UQL–AF post-urodynamic study score was significantly lower in the first group that received the illustrated form (p =0.014). A remarkable correlation was observed between HADS and UQL-AF scores.
Interpretation of results
In this study, urodynamic investigations were shown to cause significant anxiety in at least half of the patients by using the HADS. In the first group who received the illustrated information sheet, mean total HADS scores and the proportion of having notable anxiety (HADS anxiety score≥8) were lower, although the difference was not statistically significant. However, a larger study may provide that using an illustrated sheet can significantly improve the degree of anxiety levels during urodynamics.
Concluding message
It was determined that UQL-AF, which we prepared specifically for the urodynamic investigation, was correlated with HADS. However, multicenter patient series are certainly needed for the validation of this new scale. When this is provided, UQL-AF may detect the patients with severe anxiety both before and after the urodynamic study and by applying a special anxiety-reducing approach to this group, both better results from the urodynamic investigation can be obtained and patient comfort can be increased.
Figure 1 Table 1. Comparison of the number of patients with "Hospital Anxiety and Depression Scale" (HADS) scores with borderline and abnormal results for the pre- and post-urodynamic periods in both randomization groups
Figure 2 Table 2. Urodynamics Quality of Life-Anxiety Form (UQL-AF) before and after the procedure for the largest, smallest, and mean values and the change of mean values according to the randomization groups
References
  1. Suskind AM, Clemens JQ, Kaufman SR, Stoffel JT, Oldendorf A, Malaeb BS, et al. Patient perceptions of physical and emotional discomfort related to urodynamic testing: a questionnaire-based study in men and women with and without neurologic conditions. Urology. 2015;85(3):547-51.
  2. Yokoyama T, Nozaki K, Nose H, Inoue M, Nishiyama Y, Kumon H. Tolerability and morbidity of urodynamic testing: a questionnaire-based study. Urology. 2005;66(1):74-6.
  3. Bright E, Parsons BA, Swithinbank L. Increased patient information does not reduce patient anxiety regarding urodynamic studies. Urol Int. 2011;87(3):314-8.
Disclosures
Funding None Clinical Trial No Subjects Human Ethics Committee 09.2020.899 Helsinki Yes Informed Consent Yes
Citation

Continence 2S2 (2022) 100253
DOI: 10.1016/j.cont.2022.100253

18/04/2024 10:01:58