Urinary IncontinenceNCT02746913
Ambulatory Pessary Trial
A study testing Urodynamics and Pessary in people with Urinary Incontinence, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to compare two methods for assessing patients with pelvic organ prolapse for occult stress urinary incontinence. Urodynamic testing is the most widely accepted and well-studied method for diagnosing occult stress urinary incontinence preoperatively, but an ambulatory pessary trial is a… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Urodynamics and Pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2017to Dec 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Patients planning to undergo pelvic organ prolapse surgery and preoperative urodynamic testing within 6 months of recruitment.
- Stage 2 or greater pelvic organ prolapse on pre op POP-Q exam
- Negative stress test on clinical exam
- Cognitive capacity to complete questionnaires and voiding diary
Who cannot join
- Stress incontinence during provocative stress test on pre-operative exam.
- Occult stress urinary incontinence demonstrated on pre-operative physical exam
- Known ability to retain a pessary for the 3 day trial
- < age 18
- History of bladder augmentation or artificial sphincter
- Known neurologic disease effecting bladder (spinal cord injury, Multiple Sclerosis, Parkinson's Disease, etc.)
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- Non ambulatory patients
- Active infections of the vagina or pelvis (Pelvic inflammatory disease, infectious vaginitis, etc.)
- Occult stress urinary incontinence demonstrated on pre-operative physical exam
- Known ability to retain a pessary for the 3 day trial
- < age 18
- History of bladder augmentation or artificial sphincter
- Known neurologic disease effecting bladder (spinal cord injury, Multiple Sclerosis, Parkinson's Disease, etc.)
- Non ambulatory patients
- Active infr
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10016
About this study
Official title: Ambulatory Pessary Trial as a Preoperative Method for Diagnosing Occult Stress Urinary Incontinence
The purpose of this study is to compare two methods for assessing patients with pelvic organ prolapse for occult stress urinary incontinence. Urodynamic testing is the most widely accepted and well-studied method for diagnosing occult stress urinary incontinence preoperatively, but an ambulatory pessary trial is a less expensive option that is available to a wider group of practitioners and evaluates patient while they are engaged in their daily activities.
- Conditions
- Urinary Incontinence
- Being tested
- Urodynamics, Pessary
- Keywords
- Pelvic, Urodynamic, Vaginal Wall
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrodynamicsDevice
Urodynamics is performed with the Aquarius XT Laborie system and a fluoroscopic images are obtained with a GE OCE 9800 c-arm fluoroscopy unit. Urodynamic testing will be performed in a seated position with a pessary from the ambulatory pessary trial in place. Post residual void will be measured at the start of the urodynamics.
PessaryDevice
A pessary is a silicone disc that is used in to support the uterus and vagina of women with vaginal prolapse. During this study, the pessary that will be used is a ring with support. This is a disc shape with a membrane stretched across the center. It is a device used in standard practice and is safe to keep in place for up to 3 months at a time. The subjects will be fit with a pessary asked to wear the pessary for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Urodynamics, followed by Pessary | Experimental | Not described Receives: Device: Urodynamics; Device: Pessary |
| Pessary, followed by Urodynamics | Experimental | Not described Receives: Device: Urodynamics; Device: Pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire
leakage on a voiding diary.
Measured: 3 Days
Overactive bladder quality of life (QAB-Q)- short term questionnaire
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startNov 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Brucker, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746913
- Sponsor's protocol ID
- 15-00598
- Status last verified
- Sep 2017
- First submitted
- 18 Apr 2016
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Pessary Trial as a Preoperative Method for Diagnosing Occult Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02746913
- Acronym / sponsor ID
- 15-00598
- Conditions
- Urinary Incontinence
- Keywords
- Pelvic, Urodynamic, Vaginal Wall
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Apr 2016 (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 compare two methods for assessing patients with pelvic organ prolapse for occult stress urinary incontinence. Urodynamic testing is the most widely accepted and well-studied method for diagnosing occult stress urinary incontinence preoperatively, but an ambulatory pessary trial is a less expensive option that is available to a wider group of practitioners and evaluates patient while they are engaged in their daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urodynamics, followed by Pessary | Experimental | Device: Urodynamics, Device: Pessary |
| Pessary, followed by Urodynamics | Experimental | Device: Urodynamics, Device: Pessary |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Patients planning to undergo pelvic organ prolapse surgery and preoperative urodynamic testing within 6 months of recruitment.
- Stage 2 or greater pelvic organ prolapse on pre op POP-Q exam
- Negative stress test on clinical exam
- Cognitive capacity to complete questionnaires and voiding diary
Key exclusion criteria (15 listed)
- Stress incontinence during provocative stress test on pre-operative exam.
- Occult stress urinary incontinence demonstrated on pre-operative physical exam
- Known ability to retain a pessary for the 3 day trial
- < age 18
- History of bladder augmentation or artificial sphincter
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 |
|---|---|---|
| UrodynamicsUrodynamics is performed with the Aquarius XT Laborie system and a fluoroscopic images are obtained with a GE OCE 9800 c-arm fluoroscopy unit. Urodynamic testing will be performed in a seated position with a pessary from the ambulatory pessary trial in place. Post residual void will be measured at the start of the urodynamics. | Device | Pessary, followed by Urodynamics, Urodynamics, followed by Pessary |
| PessaryA pessary is a silicone disc that is used in to support the uterus and vagina of women with vaginal prolapse. During this study, the pessary that will be used is a ring with support. This is a disc shape with a membrane stretched across the center. It is a device used in standard practice and is safe to keep in place for up to 3 months at a time. The subjects will be fit with a pessary asked to wear the pessary for 3 days. | Device | Pessary, followed by Urodynamics, Urodynamics, followed by Pessary |
Primary outcome
Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire
Time frame: 3 Days
leakage on a voiding diary.
Overactive bladder quality of life (QAB-Q)- short term questionnaire
Time frame: 3 days
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 11 Sep 2017.
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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.
Benjamin Brucker, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urodynamics and Pessary in people with Urinary Incontinence, run by NYU Langone Health 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 5 inclusion and 15 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 11 Sep 2017. 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?
Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire (time frame: 3 Days). The study lists 2 primary outcomes in all. 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 11 Sep 2017.