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

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%.

Study Overview

• Status: Unknown
• Conditions: Lower Urinary Tract Symptoms; Adjustment Disorders
• Intervention / Treatment: Other: ICIQ-FLUTS, ADMN-20

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of adjustment disorders among women with lower urinyry tract symptoms	9 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between ICIQ-FLUTS and ADNM-20 scores	9 Months

Collaborators and Investigators

• Sponsor: Basel Women's University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Urological Manifestations; Trauma and Stressor Related Disorders; Lower Urinary Tract Symptoms; Adjustment Disorders
• Other Study ID Numbers: LUTS and AD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No