LUTS and AD: Lower Urinary Tract Symptoms in Women and Adjustment Disorder
Sponsor
Basel Women's University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03444740
Collaborator
(none)
100
12
Study Details
Study Description
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%.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Do Women Seeking Medical Assistance for Lower Urinary Tract Symptoms Have a High Prevalence of Adjustment Disorder?A Questionnaire Based Study
Anticipated Study Start Date
:
Mar 1, 2018
Anticipated Primary Completion Date
:
Dec 1, 2018
Anticipated Study Completion Date
:
Mar 1, 2019
Outcome Measures
Primary Outcome Measures
- Prevalence of adjustment disorders among women with lower urinyry tract symptoms [9 Months]
Secondary Outcome Measures
- Correlation between ICIQ-FLUTS and ADNM-20 scores [9 Months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Basel Women's University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tilemachos Kavvadias,
MD,
Basel Women's University Hospital
ClinicalTrials.gov Identifier:
NCT03444740
Other Study ID Numbers:
- LUTS and AD
First Posted:
Feb 23, 2018
Last Update Posted:
Feb 23, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: