There is a need for a modern assessment tool for OAB which overcomes the limitations of today's retrospective questionnaires. Therefore, a urological ESM tool, the "Uromate," is being developed as a PROM, following the FDA PROM development guidelines, to measure real-time symptoms in the context of daily life.
Objectives: To investigate the differences in bladder sensations of overactive bladder (OAB) patients compared to healthy volunteers. In addition, to see if bladder sensations are different in men and women. Methods: In a prospective, longitudinal study (METC 09-2-095), 66 volunteers and 68 OAB patients were included. Anticholinergic medication was stopped. Subjects filled out a sensation-related bladder diary (SR-BD), for two periods of 3 days, including a 4-points urgency scale and visual analogue scale for perception of bladder fullness. Results: In total, 6160 voids were assessed. Patients voided more often with higher degrees of urge at a lower mean voided volume (193 vs 270 ml/void; p < 0.001) than healthy volunteers. The mean urinary frequency per litre diuresis was also higher (5.8 vs 4.1/l; p < 0.001) in patients. At the same voided volume: patients perceived a higher mean bladder fullness, independent of the degree of urge, and higher urgency (1.4 vs 0.5/100 ml; p < 0.001) than healthy volunteers. There were no gender differences in the above-mentioned voiding parameters, except for the mean voided volume at urge 3 in volunteers (340 ml in men vs 362 ml in women; p ¼ 0.03) and urge 1 in patients (171 ml in men vs 135 ml in women; p ¼ 0.027). Conclusions: Bladder sensations were significantly increased in everyday life for both male and female OAB patients compared to healthy volunteers. OAB patients experienced a higher mean bladder fullness sensation, independent of the degree of urge, and higher mean urge/urgency at the same voided volume than volunteers. Bladder sensations are crucial in the assessment of treatment response.
ARTICLE HISTORY
Background
Symptoms related to endometriosis have a significant impact on the quality of life, and symptoms often recur. The experience sampling method (ESM), a digital questioning method characterized by randomly repeated momentary assessments, has several advantages over traditionally used measurements, including the ability to assess the temporal relationship between variables such as physical, mental, and social factors.
Objective
The aim of this study is to develop an ESM tool for patients with endometriosis to accurately measure symptoms and their course over time, allowing for personalized treatment and adequate monitoring of treatment efficacy in individual patients.
Methods
On the basis of international guidelines, items from validated questionnaires were selected through a literature review and during focus groups and multidisciplinary expert meetings. Data analysis was conducted using ATLAS.ti (ATLAS.ti Scientific Software Development GmbH). The feasibility and usability of the newly developed momentary assessment tool were tested for 28 consecutive days in 5 patients with endometriosis-related pain symptoms.
Results
Momentary assessment items contained questions concerning endometriosis symptoms, general somatic symptoms, psychological symptoms, contextual information, and the use of food and medication. A morning questionnaire on sleep and sexuality was included. In a pilot study, the patients considered the tool easy to use but time consuming. The average compliance rate of momentary assessments was 37.8% (106/280), with the highest completion rate during the first week (39/70, 56%). Therefore, it is advisable to use the ESM for a maximum of 7 days.
Conclusions
A new digital tool for endometriosis symptom assessment was developed using the ESM, which may help overcome the limitations of current retrospective questionnaires. After validation and testing, future studies will be planned to evaluate the use of this tool in a clinical setting in order to propose a personalized treatment plan for women with endometriosis.
BACKGROUND
Symptoms related to endometriosis have a significant impact on the quality of life, and symptoms often recur. The experience sampling method (ESM), a digital questioning method characterized by randomly repeated momentary assessments, has several advantages over traditionally used measurements, including the ability to assess the temporal relationship between variables such as physical, mental, and social factors.
OBJECTIVE
The aim of this study is to develop an ESM tool for patients with endometriosis to accurately measure symptoms and their course over time, allowing for personalized treatment and adequate monitoring of treatment efficacy in individual patients.
METHODS
On the basis of international guidelines, items from validated questionnaires were selected through a literature review and during focus groups and multidisciplinary expert meetings. Data analysis was conducted using ATLAS.ti (ATLAS.ti Scientific Software Development GmbH). The feasibility and usability of the newly developed momentary assessment tool were tested for 28 consecutive days in 5 patients with endometriosis-related pain symptoms.
RESULTS
Momentary assessment items contained questions concerning endometriosis symptoms, general somatic symptoms, psychological symptoms, contextual information, and the use of food and medication. A morning questionnaire on sleep and sexuality was included. In a pilot study, the patients considered the tool easy to use but time consuming. The average compliance rate of momentary assessments was 37.8% (106/280), with the highest completion rate during the first week (39/70, 56%). Therefore, it is advisable to use the ESM for a maximum of 7 days.
CONCLUSIONS
A new digital tool for endometriosis symptom assessment was developed using the ESM, which may help overcome the limitations of current retrospective questionnaires. After validation and testing, future studies will be planned to evaluate the use of this tool in a clinical setting in order to propose a personalized treatment plan for women with endometriosis.
CLINICALTRIAL
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