Lower Urinary Tract Symptoms in Women and Adjustment Diso... | NCT03444740

Studies
Lower Urinary Tract Symptoms in Women and Adjustment Disorder

NCT03444740

Sponsor

Basel Women's University Hospital

Status

Unknown status

Last Update Posted

Feb 23, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Lower Urinary Tract Symptoms
Adjustment Disorders

Interventions

ICIQ-FLUTS, ADMN-20

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2018Estimated

Primary Completion Date

Dec 2018Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Feb 19, 2018

First Submission Date that Met QC Criteria

Feb 22, 2018

First Posted Date

Feb 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2018

Last Update Posted Date

Feb 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tilemachos Kavvadias, MD, Basel Women's University HospitalPrincipal Investigator

Lead Sponsor

Basel Women's University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
ICIQ-FLUTS, ADMN-20	Other	Questionnaire

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059411	Lower Urinary Tract Symptoms
D000275	Adjustment Disorders

Ancestor Terms

ID	Term
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D000068099	Trauma and Stressor Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided