CystoceleLUTS-2NCT01616810
Lower Urinary Tract Symptoms Screening Questionnaire
An observational study of Cystocele, run by Unity Health Toronto.
Trial summary
The purpose of this study is to determine the validity of a screening tool which has been designed to detect the presence or absence of lower urinary tract symptoms in the general female population. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystocele
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2011
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants, 18 years of age and older with any gynecological symptoms other than lower urinary tract symptoms or pelvic floor dysfunction
Who may be able to join
- Healthy participants, 18 years of age and older with any gynecological symptoms
Who cannot join
- Patients with lower urinary tract symptoms and pelvic floor dysfunction
About this study
Official title: Lower Urinary Tract Symptoms Screening Questionnaire Validation STudy
The purpose of this study is to determine the validity of a screening tool which has been designed to detect the presence or absence of lower urinary tract symptoms in the general female population.
- Conditions
- Cystocele
- Keywords
- urinary tract
- Medical subject headings
- Cystocele
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 |
|---|---|---|
| observation | Healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of lower urinary tract symptoms in the general female population
To validate the effectiveness of a screening tool in detecting the presence or absence of lower urinary tract symptoms in the general female population.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJan 2007
- Primary completionOct 2007
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoceleStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Soroka, MD, FRCS(C), Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616810
- Sponsor's protocol ID
- 04-227
- Acronym
- LUTS-2
- Status last verified
- Feb 2019
- First submitted
- 26 Aug 2011
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Urinary Tract Symptoms Screening Questionnaire Validation STudy
- ClinicalTrials.gov ID
- NCT01616810
- Acronym / sponsor ID
- LUTS-2 / 04-227
- Conditions
- Cystocele
- Keywords
- urinary tract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Jun 2012 (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.
The purpose of this study is to determine the validity of a screening tool which has been designed to detect the presence or absence of lower urinary tract symptoms in the general female population.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation | – | –Healthy participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants, 18 years of age and older with any gynecological symptoms other than lower urinary tract symptoms or pelvic floor dysfunction
Key inclusion criteria (1 listed)
- Healthy participants, 18 years of age and older with any gynecological symptoms
Key exclusion criteria (1 listed)
- Patients with lower urinary tract symptoms and pelvic floor dysfunction
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
Presence or absence of lower urinary tract symptoms in the general female population
Time frame: Five years
To validate the effectiveness of a screening tool in detecting the presence or absence of lower urinary tract symptoms in the general female population.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
Related trials for Cystocele
Active, not recruiting
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
Visceral Prolapse
Recruiting
Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration
Pelvic Organ Prolapse (POP), Cystocele
RecruitingObservational study
Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh
Long Term Follow-Up, Transvaginal Cystocele Repair
Recruiting
Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Pelvic Organ Prolapse, Cystocele
Recruiting
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Colorectal Disorders, Prolapse
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.
Dana Soroka, MD, FRCS(C) principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of Cystocele, run by Unity Health Toronto.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence or absence of lower urinary tract symptoms in the general female population (time frame: Five years). 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 22 Feb 2019.