Lower Urinary Tract SymptomsLUTS and ADNCT03444740
Lower Urinary Tract Symptoms in Women and Adjustment Disorder
An observational study of Lower Urinary Tract Symptoms and Adjustment Disorders, run by Basel Women's University Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Adjustment Disorders
- What is being tested?
- ICIQ-FLUTS, ADMN-20
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- Female patients seeking medical help for lower urinary tract symptoms
- German speaking
Who cannot join
- Pelvic floor Prolapse symptoms or Stage III or more by medical examination
- Inability to understand the purpose of the study
About this study
Official title: 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%.
- Conditions
- Lower Urinary Tract Symptoms, Adjustment Disorders
- Being tested
- ICIQ-FLUTS, ADMN-20
- Medical subject headings
- Lower Urinary Tract Symptoms, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICIQ-FLUTS, ADMN-20Other
Questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of adjustment disorders among women with lower urinyry tract symptoms
Measured: 9 Months
Secondary outcomes (1)
Correlation between ICIQ-FLUTS and ADNM-20 scores
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study startMar 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basel Women's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tilemachos Kavvadias, Basel Women's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444740
- Sponsor's protocol ID
- LUTS and AD
- Acronym
- LUTS and AD
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Women Seeking Medical Assistance for Lower Urinary Tract Symptoms Have a High Prevalence of Adjustment Disorder?A Questionnaire Based Study
- ClinicalTrials.gov ID
- NCT03444740
- Acronym / sponsor ID
- LUTS and AD / LUTS and AD
- Conditions
- Lower Urinary Tract Symptoms, Adjustment Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Basel Women's University HospitalUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (2 listed)
- Female patients seeking medical help for lower urinary tract symptoms
- German speaking
Key exclusion criteria (2 listed)
- Pelvic floor Prolapse symptoms or Stage III or more by medical examination
- Inability to understand the purpose of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICIQ-FLUTS, ADMN-20Questionnaire | Other | – |
Primary outcome
Prevalence of adjustment disorders among women with lower urinyry tract symptoms
Time frame: 9 Months
1 secondary outcome
Correlation between ICIQ-FLUTS and ADNM-20 scores
Time frame: 9 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms and Adjustment Disorders, run by Basel Women's University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of adjustment disorders among women with lower urinyry tract symptoms (time frame: 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.