An interventional study of C3 "UMBRELLA CATHETER" in Urinary Retention, Urinary Bladder, Neurogenic and Intermittent Catheterization, sponsored by Dr. Gaines W. Hammond Jr. MD FACS. Status unknown at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-27.
Sponsored by Dr. Gaines W. Hammond Jr. MD FACS · Not applicable, Interventional, and Other
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 54th largest by planned enrollment of the 81 interventional ones, is one of 12 that started in 2017, is one of 53 with no phase, and was the 44th registered.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 187 interventional 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: 21 Years and older · female · healthy volunteers too.
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:
Dr. Gaines W. Hammond Jr. MD FACS is the lead sponsor of 2 studies on the registry; none are open to participants now.
Dr. Gaines W. Hammond Jr. MD FACS has 2 studies 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:
The Catheter Science C3 "Umbrella Catheter" has been developed for management of urinary retention in patients who are either using a Foley or Self Intermittent Catheter. This device is inserted into the bladder in an extended state and once the stylet is removed the device folds into collapsed state. A thread is attached to the device and traverses thru the urethra and is attached to a bobber. With gentle traction on the thread the device engages the bladder neck and the central tube extends which allows for the flow of urine. Once voiding is complete, the thread is released and the device collapses back to the folded state into the bladder. Each voiding cycle is accomplished in a similar fashion. This is a novel technique in which the bladder is catheterized with the device from within the bladder into the bladder neck and urethra. The standard self catheter technique is for placement of a catheter from the outside into the urethra and into the bladder.
Interventional (clinical trial): Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes.
This single arm, prospective study is designed to produce valid scientific evidence regarding:
A single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. The C3 catheterizes the bladder with engagement into the bladder neck under the control of the patient or care giver. A Foley catheter, a pre- amendment device, was considered for a control treatment. However, although a Foley catheter is used to establish urinary drainage with close to 100% efficacy, it does not restore voiding function like the C3, and severely impairs activities of daily life.
The intrinsic design flaws of a Foley catheter traversing thru the urinary passage which violates the anatomical protective points which help to avoid bacterial contamination. The distal 1/3 portion of the urethra in females is commonly colonized with bacteria. Standard Catheter technique traverses from the outside into the entire length of the urethra to drain the bladder. The standard self catheter flow characteristics are impacted due to the placements of the "eyes" to the catheter lumen. The C3 lumen is open in line with the flow.
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:
This single arm prospective study is designed to produce valid scientific evidence regarding safety and efficacy of the C3 in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days in patients. The total study population will initially include 50 subjects with open enrollment of additional subjects.
Device: C3 "UMBRELLA CATHETER"
The C3 is an alternative method to facilitate bladder drainage in the study population which are using either a foley catheter or Clean Intermittent Catheter technique to drain the bladder.
Catheterization of the bladder from an antegrade direction with the C3 device.
The percentage for patients enrolled in the student with the C3 inserted who are able to engage the tubular portion of the device into the bladder neck and urethra from the default position in the bladder with resultant drainage of the bladdder.
Time frame: Measurement of data points are collected sequentially every 7 days up to 28 days.
The retreat of the C3 back into the bladder from the engaged position
The percentage of enrolled patients who upon completion of bladder drainage with the engaged tubular portion of the C3 in bladder neck and urethral location retreats back into the default position in the bladder.
Time frame: Measurement of data points are collected sequentially every 7 days up to 28 days.
Reduction in Catheter Acquired Urinary Tract Infection Rate
The reduction in Catheter Acquired Urinary Tract Infection (CAUTI) with the C3 "Umbrella Catheter" as compared to the expected incidence with either a Foley Catheter or Self Intermittent Catheter for bladder drainage.
Time frame: Measurement of data points are collected sequentially every 7 days up to 28 days.
Plan to share: Yes — LISTED IN STUDY INFORMED CONSENT WITH NAME RECOGNITION WITHHELD
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After completion of the study which is anticipated to be March 2018 for a period of 2 years post completion.
Access criteria: Access with proper credentials with the patient identifying markers withheld.
No publications or documents are linked to this record.
Started Aug 2017 (actual). Primary completion is estimated for Mar 2018, 7 months after the start.
Of 70 non-industry interventional studies with no phase under Urinary Retention, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 7 months is below that.
Counting every sponsor, half of 82 studies reached it within 18 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Dr. Gaines W. Hammond Jr. MD FACS