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Trial record 6 of 274 for:    Recruiting, Not yet recruiting, Available Studies | "Lower Urinary Tract Symptoms"

Lower Urinary Tract Symptoms in Women and Adjustment Disorder (LUTS and AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03444740
Recruitment Status : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Information provided by (Responsible Party):
Tilemachos Kavvadias, Basel Women’s University Hospital

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
Lower Urinary Tract Symptoms Adjustment Disorders Other: ICIQ-FLUTS, ADMN-20

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Study Type : Observational
Estimated 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
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: ICIQ-FLUTS, ADMN-20

Primary Outcome Measures :
  1. Prevalence of adjustment disorders among women with lower urinyry tract symptoms [ Time Frame: 9 Months ]

Secondary Outcome Measures :
  1. Correlation between ICIQ-FLUTS and ADNM-20 scores [ Time Frame: 9 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

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

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Responsible Party: Tilemachos Kavvadias, MD, Basel Women’s University Hospital Identifier: NCT03444740     History of Changes
Other Study ID Numbers: LUTS and AD
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Adjustment Disorders
Pathologic Processes
Urological Manifestations
Signs and Symptoms
Trauma and Stressor Related Disorders
Mental Disorders