LeiomyomaNCT00827645
Uterine Artery Embolization and Pelvic Floor Symptoms
An observational study of Leiomyoma and Incontinence, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The objective of this study is to determine whether women who are already receiving treatment for their fibroids (ie. UAE) demonstrate improvement in urinary symptoms and sexual dysfunction as well. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma, Incontinence, Prolapse
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2009to 1 Jan 2013
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with symptomatic uterine fibroids who are scheduled for uterine artery embolization
Who may be able to join
- female
- age 18-80 years
- symptomatic uterine fibroids
- scheduled for UAE
- Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative UA or negative culture (Urine dipstick is performed as standard of care)
- Available for 12-months of follow-up and able to complete study assessments, per clinician judgment
- Signed consent form
Who cannot join
- Age <18 or >80 years
- women who are unable to read and write English,
- pregnancy or planned pregnancy in the next 12 months
- < 6 months postpartum
- current use of anticholinergic medication, cholinergic agonists, tricyclic antidepressants, or duloxetine - must have been off such drugs for at least 4 weeks
- women with surgery for urinary incontinence or pelvic organ prolapse in the past 6 months
Show all 9Show fewer
- history of bladder or pelvic cancer or pelvic radiation therapy
- prior augmentation cystoplasty
- urethral diverticulum, current or repaired.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction
The objective of this study is to determine whether women who are already receiving treatment for their fibroids (ie. UAE) demonstrate improvement in urinary symptoms and sexual dysfunction as well.
- Conditions
- Leiomyoma, Incontinence, Prolapse
- Medical subject headings
- Leiomyoma, Prolapse
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 |
|---|---|---|
| Uterine artery embolization | Women with symptomatic uterine fibroids scheduled for uterine artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary symptoms as demonstrated by questionnaires
Measured: 1 year
Secondary outcomes (1)
Sexual dysfunction as defined by questionnaires
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study start1 Jan 2009
- Primary completion1 Jan 2013
- Study completion1 Jan 2013
Why it stopped: never funded and never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clifford Y Wai, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827645
- Sponsor's protocol ID
- 112008-033
- Status last verified
- May 2018
- First submitted
- 21 Jan 2009
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Uterine Artery Embolization on Symptoms of Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT00827645
- Acronym / sponsor ID
- 112008-033
- Conditions
- Leiomyoma, Incontinence, Prolapse
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: never funded and never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Jan 2013 (actual)
- Study completion
- 1 Jan 2013 (actual)
- First posted
- 23 Jan 2009 (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 objective of this study is to determine whether women who are already receiving treatment for their fibroids (ie. UAE) demonstrate improvement in urinary symptoms and sexual dysfunction as well.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterine artery embolization | – | –Women with symptomatic uterine fibroids scheduled for uterine artery embolization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with symptomatic uterine fibroids who are scheduled for uterine artery embolization
Key inclusion criteria (7 listed)
- female
- age 18-80 years
- symptomatic uterine fibroids
- scheduled for UAE
- Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative UA or negative culture (Urine dipstick is performed as standard of care)
Key exclusion criteria (9 listed)
- Age <18 or >80 years
- women who are unable to read and write English,
- pregnancy or planned pregnancy in the next 12 months
- < 6 months postpartum
- current use of anticholinergic medication, cholinergic agonists, tricyclic antidepressants, or duloxetine - must have been off such drugs for at least 4 weeks
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
Urinary symptoms as demonstrated by questionnaires
Time frame: 1 year
1 secondary outcome
Sexual dysfunction as defined by questionnaires
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
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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.
Clifford Y Wai, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiomyoma and Incontinence, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Urinary symptoms as demonstrated by questionnaires (time frame: 1 year). 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 May 2018.