Urinary RetentionNCT02150083
Trial of Two Techniques to Assess Postoperative Voiding Function
A study testing OR retrograde fill in people with Urinary Retention, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women. Many surgical procedures have been developed to treat SUI, and midurethral slings have gradually become the first line treatment. 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
- Urinary Retention
- What is being tested?
- OR retrograde fill
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking
- Women over the age of 18
- Patients with stress urinary incontinence planning to undergo midurethral sling placement
Who cannot join
- Prior incontinence surgery
- Concomitant surgery for pelvic organ prolapse except for anterior repair
- Intraoperative cystotomy
- Patients taking anticholinergic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Diagnostic Accuracy of Two Techniques for Assessing Postoperative Voiding Function - A Randomized Trial
Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women. Many surgical procedures have been developed to treat SUI, and midurethral slings have gradually become the first line treatment. Voiding dysfunction, or inability for a patient to empty her bladder, immediately after surgery is common. A bladder test is often performed in the recovery area to see if the patient is able to empty her bladder. This typically consists of filling the bladder with 300 mL of saline through the foley catheter. The catheter is then removed and the patient is asked to void. The investigators then measure the voided volume and the residual left inside the bladder to determine if she is able to empty her bladder sufficiently or not. A successful voiding trial is defined as voiding 2/3 of the total volume in the bladder and having less than 100 mL left inside the bladder as residual. Our goal of this study was to evaluate efficiency and effectiveness of a retrograde postoperative voiding trial that is initiated in the operating room. Our hypothesis was that a retrograde postoperative voiding trial initiated in the operating room would be as effective as a standard retrograde postoperative voiding trial to predict postoperative voiding dysfunction while allowing for patients to spend less time in the recovery unit.
- Conditions
- Urinary Retention
- Being tested
- OR retrograde fill
- Keywords
- midurethral sling, voiding study, voiding trial, retrograde voiding trial
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OR retrograde fillProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| OR retrograde fill | Experimental | At completion of sling placement in the operating room, the bladder will be filled retrograde via a cystoscope with 300 mL sterile saline or water to inspect for bladder perforation. The cystoscope is removed and the foley catheter is NOT replaced for the duration of the surgery. The surgery is completed and the patient is transferred to the post-anesthesia care unit. Once she is able to ambulate, she will be instructed to void. The voided volume and residual volume will be recorded. Receives: Procedure: OR retrograde fill |
| PACU retrograde fill | No intervention | At completion of sling placement in the operating room, the bladder will be filled retrograde via a cystoscope with 300 mL sterile saline or water to inspect for bladder perforation. The cystoscope is removed and the foley catheter is replaced for the duration of the surgery and when complete the patient is transferred to the post-anesthesia care unit. Once she is able to ambulate, she will undergo a retrograde bladder fill with 300 mL of normal saline. The foley catheter will be removed and she will be instructed to void. The voided volume and residual volume will be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of subjects who passed the voiding trial between the two groups
Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit
Measured: Close of incision until discharge, approximately 3 hours.
Secondary outcomes (1)
Comparison of length of stay in post-anesthesia care unit between the two groups
Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit
Measured: Close of incision until discharge, approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startNov 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Matthews, MD, Study director, University of North CarolinaErinn Myers, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150083
- Sponsor's protocol ID
- 11-1950
- Status last verified
- May 2014
- First submitted
- 23 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Two Techniques for Assessing Postoperative Voiding Function - A Randomized Trial
- ClinicalTrials.gov ID
- NCT02150083
- Acronym / sponsor ID
- 11-1950
- Conditions
- Urinary Retention
- Keywords
- midurethral sling, voiding study, voiding trial, retrograde voiding trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 May 2014 (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.
Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women. Many surgical procedures have been developed to treat SUI, and midurethral slings have gradually become the first line treatment. Voiding dysfunction, or inability for a patient to empty her bladder, immediately after surgery is common. A bladder test is often performed in the recovery area to see if the patient is able to empty her bladder. This typically consists of filling the bladder with 300 mL of saline through the foley catheter. The catheter is then removed and the patient is asked to void. The investigators then measure the voided volume and the residual left inside the bladder to determine if she is able to empty her bladder sufficiently or not. A successful voiding trial is defined as voiding 2/3 of the total volume in the bladder and having less than 100 mL left inside the bladder as residual. Our goal of this study was to evaluate efficiency and effectiveness of a retrograde postoperative voiding trial that is initiated in the operating room. Our hypothesis was that a retrograde postoperative voiding trial initiated in the operating room would be as effective as a standard retrograde postoperative voiding trial to predict postoperative voiding dysfunction while allowing for patients to spend less time in the recovery unit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OR retrograde fill | Experimental | Procedure: OR retrograde fillAt completion of sling placement in the operating room, the bladder will be filled retrograde via a cystoscope with 300 mL sterile saline or water to inspect for bladder perforation. The cystoscope is removed and the foley catheter is NOT replaced for the duration of the surgery. The surgery is completed and the patient is transferred to the post-anesthesia care unit. Once she is able to ambulate, she will be instructed to void. The voided volume and residual volume will be recorded. |
| PACU retrograde fill | No intervention | –At completion of sling placement in the operating room, the bladder will be filled retrograde via a cystoscope with 300 mL sterile saline or water to inspect for bladder perforation. The cystoscope is removed and the foley catheter is replaced for the duration of the surgery and when complete the patient is transferred to the post-anesthesia care unit. Once she is able to ambulate, she will undergo a retrograde bladder fill with 300 mL of normal saline. The foley catheter will be removed and she will be instructed to void. The voided volume and residual volume will be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Women over the age of 18
- Patients with stress urinary incontinence planning to undergo midurethral sling placement
Key exclusion criteria (4 listed)
- Prior incontinence surgery
- Concomitant surgery for pelvic organ prolapse except for anterior repair
- Intraoperative cystotomy
- Patients taking anticholinergic medication
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 |
|---|---|---|
| OR retrograde fill | Procedure or surgery | OR retrograde fill |
Primary outcome
Comparison of the proportion of subjects who passed the voiding trial between the two groups
Time frame: Close of incision until discharge, approximately 3 hours.
Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit
1 secondary outcome
Comparison of length of stay in post-anesthesia care unit between the two groups
Time frame: Close of incision until discharge, approximately 3 hours
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 29 May 2014.
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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.
Catherine Matthews, MD study director
University of North Carolina
Erinn Myers, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OR retrograde fill in people with Urinary Retention, run by University of North Carolina, Chapel Hill 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 3 inclusion and 4 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 29 May 2014. 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 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?
Comparison of the proportion of subjects who passed the voiding trial between the two groups (time frame: Close of incision until discharge, approximately 3 hours.). 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 29 May 2014.