Status unknownNCT03444740LUTS and ADUpdated Feb 23, 2018

Lower Urinary Tract Symptoms in Women and Adjustment Disorder

An observational study in Lower Urinary Tract Symptoms and Adjustment Disorders, sponsored by Basel Women's University Hospital. Status unknown. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by Basel Women's University Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Cross-sectional
Enrollment: 100
Ages: 18 Years to 75 Years
Sex: Female

Study 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%.

Conditions studied

Lower Urinary Tract Symptoms
Adjustment Disorders

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Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: Female
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

Exclusion Criteria:

Pelvic floor Prolapse symptoms or Stage III or more by medical examination
Inability to understand the purpose of the study

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Enrollment: 100 participants (estimated)
Patient registry: No

Interventions

OtherICIQ-FLUTS, ADMN-20
Questionnaire

What researchers measure

Primary outcomes

Prevalence of adjustment disorders among women with lower urinyry tract symptoms
Time frame: 9 Months

Secondary outcomes

Correlation between ICIQ-FLUTS and ADNM-20 scores
Time frame: 9 Months

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03444740
Lead sponsor: Basel Women's University Hospital
Responsible party: Tilemachos Kavvadias (MD, Basel Women's University Hospital) — Principal investigator
First posted: Feb 23, 2018
Start date: Mar 2018 (estimated)
Primary completion: Dec 2018 (estimated)
Completion: Mar 2019 (estimated)
Last update: Feb 23, 2018

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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