Urinary IncontinenceNCT00530036
Burden of Urinary Incontinence in Home Care Patients in the State of Geneva
An observational study of Urinary Incontinence, run by University Hospital, Geneva.
Trial summary
Urinary incontinence (UI) is a frequent problem in community-dwelling older adults and has a huge burden on health complications and healthcare costs. Although effective treatments exist, UI is frequently neglected resulting in unmet needs for continence treatment and potential negative health outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Incontinence
- How many people
- 699 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Between July 2004 and December 2004
- 699 adults patients followed by the "Fondation des Services d'Aide et de Soins à Domicile" in Geneva (two region in the state of Geneva: Meyrin and St-Jean)
Who cannot join
None listed.
About this study
Urinary incontinence (UI) is a frequent problem in community-dwelling older adults and has a huge burden on health complications and healthcare costs. Although effective treatments exist, UI is frequently neglected resulting in unmet needs for continence treatment and potential negative health outcomes. The impact of UI in older patients receiving home care services has not been extensively explored. In a recent study we observed that UI was identified in 46% of 699 patients followed by the "Fondation des Services d'Aide et de Soins à Domicile" in Geneva but the impact of UI on outcome such as institutionalization, hospitalization or death is unknown.
- Conditions
- Urinary Incontinence
- Keywords
- Mortality, Patient readmission, Institutionalization
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Continent | 54% of 699 patients followed as outpatient by the "Fondation des Services d'Aide et de Soins à Domicile" in Geneva without urinary incontinence | |
| Incontinent | 46% of 699 patients followed by the "Fondation des Services d'Aide et de Soins à Domicile" in Geneva and with an urinary incontinence |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startJan 2004
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Michel Jung, MD, Principal investigator, University Hospital of Geneva (HUG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530036
- Sponsor's protocol ID
- CER 06-298
- Status last verified
- Aug 2007
- First submitted
- 14 Sep 2007
- Last updated
- 17 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Jung M, Faltin DL, Rutschmann O. [Impact of urinary incontinence in community-dwelling women]. Rev Med Suisse. 2006 Oct 18;2(83):2332-5. French.
PubMed 17112083
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Urinary Incontinence in Home Care Patients in the State of Geneva
- ClinicalTrials.gov ID
- NCT00530036
- Acronym / sponsor ID
- CER 06-298
- Conditions
- Urinary Incontinence
- Keywords
- Mortality, Patient readmission, Institutionalization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 699 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Dec 2007 (estimated)
- First posted
- 17 Sep 2007 (estimated)
- 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.
Urinary incontinence (UI) is a frequent problem in community-dwelling older adults and has a huge burden on health complications and healthcare costs. Although effective treatments exist, UI is frequently neglected resulting in unmet needs for continence treatment and potential negative health outcomes. The impact of UI in older patients receiving home care services has not been extensively explored. In a recent study we observed that UI was identified in 46% of 699 patients followed by the "Fondation des Services d'Aide et de Soins à Domicile" in Geneva but the impact of UI on outcome such as institutionalization, hospitalization or death is unknown.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continent | – | –54% of 699 patients followed as outpatient by the "Fondation des Services d'Aide et de Soins à Domicile" in Geneva without urinary incontinence |
| Incontinent | – | –46% of 699 patients followed by the "Fondation des Services d'Aide et de Soins à Domicile" in Geneva and with an urinary incontinence |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Between July 2004 and December 2004
- 699 adults patients followed by the "Fondation des Services d'Aide et de Soins à Domicile" in Geneva (two region in the state of Geneva: Meyrin and St-Jean)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2007.
- Background: PubMed 17112083Jung M, Faltin DL, Rutschmann O. [Impact of urinary incontinence in community-dwelling women]. Rev Med Suisse. 2006 Oct 18;2(83):2332-5. French.
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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.
Michel Jung, MD principal investigator
University Hospital of Geneva (HUG)
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by University Hospital, Geneva.
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 0 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 17 Sep 2007. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00530036, which also lists 1 linked publication.
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 17 Sep 2007.