Lower Urinary Tract Symptoms in Women and Adjustment Disorder
LUTS and AD
Do Women Seeking Medical Assistance for Lower Urinary Tract Symptoms Have a High Prevalence of Adjustment Disorder?A Questionnaire Based Study
1 other identifier
observational
100
0 countries
N/A
Brief Summary
Our hypothesis that the prevalence of AD in uro-gynecologic patients with LUTS who are seeking medical help for their condition is higher than that of the general population (indicated by high scores at the ADNM-20; score above 48). Taking into consideration that affective disorders, anxiety and depression among patients with LUTS present with a prevalence of 17-23% \[20\] as well as through long personal experience, we hypothesize that the prevalence of AD in this group is 20%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2018
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedFebruary 23, 2018
February 1, 2018
9 months
February 19, 2018
February 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of adjustment disorders among women with lower urinyry tract symptoms
9 Months
Secondary Outcomes (1)
Correlation between ICIQ-FLUTS and ADNM-20 scores
9 Months
Interventions
Questionnaire
Eligibility Criteria
All eligible female patients at first time visits or follow-up visits who present to the uro-gynecology department of the University Hospital of Basel with LUTS (such as incontinence, OAB or recurrent UTIs) will be asked to participate in the study. After counseling and agreement the patients will be asked to sign the informed consent
You may qualify if:
- Female patients seeking medical help for lower urinary tract symptoms
- German speaking
You may not qualify if:
- Pelvic floor Prolapse symptoms or Stage III or more by medical examination
- Inability to understand the purpose of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 19, 2018
First Posted
February 23, 2018
Study Start
March 1, 2018
Primary Completion
December 1, 2018
Study Completion
March 1, 2019
Last Updated
February 23, 2018
Record last verified: 2018-02