An observational study in Urinary Retention and Acute Kidney Injury, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-04-03.
Sponsored by Washington University School of Medicine · Observational
Among 98 studies in Urinary Retention with a site in United States — 13 open to participants now, 18 under way, 1 of them phase 3. Urinary Retention · United States.
Among the 98 studies in Urinary Retention with a site in United States, this one is the 10th largest by enrollment of the 17 observational ones, is one of 12 that started in 2017, is one of 17 observational ones, and was the 48th registered.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's enrollment of 75 is below the median of 116 across 45 observational studies indexed under Urinary Retention.
Browse Urinary Retention studies →13 of the 98 studies in Urinary Retention with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 31 Urinary Retention studies recruiting now, 23 (74%) set no upper age limit and 5 (16%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →98 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 12 started in 2017.
Median enrollment 88 across the 81 interventional studies, 90 across the 17 observational. Of the 69 that completed or were terminated, 35 (51%) have results posted.
18 of 98 have an industry lead sponsor. The 10 most frequent:
Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Washington University School of Medicine has 1 study filed under Urinary Retention — fewer than ten, so there is no comparison to draw.
8 of the studies in Urinary Retention with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06179654The Cleveland ClinicPreoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate | 2026-11-30 |
| NCT04597372Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery | 2026-12 |
| NCT05200923MedtronicNeuroPelvic Health Electrically Evoked Recording (PEER) 2 Study | 2026-12-18 |
| NCT07174349Mayo ClinicUroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery | 2027-01-31 |
| NCT06918067Wake Forest University Health SciencesComparison of Urinary Flow Study | 2027-03 |
Among the 98 studies in Urinary Retention with a site in United States, from their registry updates:
ICU patients are at risk for catheter associated urinary tract infection. Frequently patients can't tell clinicians if they need to void if the catheter is removed. If clinicians know that an accurate volume measurement s of urine volume in the bladder can be obtained when the catheter is removed, catheters could be removed earlier and more frequently and thus possibly avoid an infection. For this study, measures with ultrasound (directly visualizing the bladder to measure), bladder scanner (partially blind measure with placement of scanner over the expected bladder location on the skin) and urine catheterized volume will be obtained. The investigators also want to know if the technology is user dependent. The study will include 2 levels of nurses RN and advanced practice RN (APRN) perform the bladder scanner. An APRN and MD will conduct the ultrasound. Ultrasound is technology primarily used by physicians but APRNs are using the technology technology more frequently. After these 4 measurements, the patient's nurse will perform an intermittent straight catheterization (catheter inserted, urine drained, and catheter removed) as the gold standard comparison.
The purpose of this correlational descriptive study is to compare measured bladder volumes with a bladder scanner (Verathon Prime), 3D ultrasound (Sono-Site II) and straight catheterization in ICU patients with low urine output receiving dialysis and in ICU patients unable to void.
Upon consent of patient or LAR, patient's age, gender and BMI with the assigned study code number will be recorded on enrollment log. Study code number, patient initials and unit will be written on bedside data collection sheet.
Sequence of 4 non-invasive (1-4) measurement will vary from day to day (see below)
Each enrolled patient will have these 4 measurements performed only on one day. Each clinician research team member will record their result on a data collection form with the study number, patient initials, day of week, clinician initials, observation of abdominal fluid, and comment section for any other observations. The clinician research team member will place the completed form for their measurement in an envelope with the study number on the outside while the next clinician is in the room obtaining the next measure.
Data collection is complete after catheter volume is recorded.
ICU patients with low urine output due to new acute kidney injury or patients unable to void, secondary to surgical procedure, change in level of consciousness, or neurological alteration
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
ICU patients unable to void after 6 hours after a indwelling urinary catheter is removed or since time of admission
Other: Bladder Volume Measurement bladder scanner RN · Other: Bladder Volume Measurement Ultrasound APRN · Other: Bladder Volume Measurement bladder scanner APRN · Other: Bladder Volume Measurement Ultrasound MD · Other: Intermittent Straight Catheterization
ICU patients with renal failure, acute kidney injury or acute on chronic with minimal urine output without an indwelling urinary catheter
Other: Bladder Volume Measurement bladder scanner RN · Other: Bladder Volume Measurement Ultrasound APRN · Other: Bladder Volume Measurement bladder scanner APRN · Other: Bladder Volume Measurement Ultrasound MD · Other: Intermittent Straight Catheterization
Measure Urine Volume with Bladder Scanner by RN
Also known as: Bladder Scanner
Measure Urine Volume with Point of Care Ultrasound by APRN
Also known as: Ultrasound APRN
Measure Urine Volume with Bladder Scanner by APRN
Also known as: Bladder Scanner APRN
Measure Urine Volume with Point of Care Ultrasound by MD
Also known as: Ultrasound MD
Measure Urine Volume with Intermittent Straight Catheterization
Intermittent Straight Catheterization Volume Compared to Bladder Scan Measurement Volume
Comparison of the two measurements of bladder volume will be analyzed
Time frame: At time of enrollment, one point in time
Intermittent Straight Catheterization Volume Compared to Point of Care Ultrasound Measurement Volume
Comparison of the two measurements of bladder volume will be analyzed
Time frame: At time of enrollment, one point in time
Clinician Level Measurements with Bladder Scanner and Point of Care Ultrasound
Comparison of the two measurements between clinicians 1. Bladder Scan measurement by bedside RN compared to APRN bladder scan measurement) and 2. APRN Ultrasound compared to MD US will be analyzed
Time frame: At time of enrollment, one point in time
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Jul 2018, 7 months.
Of 17 observational studies under Urinary Retention, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 50. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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