NCT03444740

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Status
unknown

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

February 19, 2018

Last Update Submit

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

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Lower Urinary Tract SymptomsAdjustment Disorders

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTrauma and Stressor Related DisordersMental Disorders

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