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NCT03444740 Clinical Trial

Lower Urinary Tract Symptoms in Women and Adjustment Disorder

Lower Urinary Tract Symptoms Clinical Trial

— LUTS and AD  

Official title:
Do Women Seeking Medical Assistance for Lower Urinary Tract Symptoms Have a High Prevalence of Adjustment Disorder?A Questionnaire Based Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03444740
Other study ID # LUTS and AD
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 19, 2018
Last updated February 22, 2018
Start date March 2018
Est. completion date March 2019

Study information
Verified date February 2018
Source Basel Women’s University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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%.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date March 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Female patients seeking medical help for lower urinary tract symptoms

- German speaking

Exclusion Criteria:

- Pelvic floor Prolapse symptoms or Stage III or more by medical examination

- Inability to understand the purpose of the study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ICIQ-FLUTS, ADMN-20
Questionnaire

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Basel Women’s University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of adjustment disorders among women with lower urinyry tract symptoms 9 Months
Secondary Correlation between ICIQ-FLUTS and ADNM-20 scores 9 Months
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