An interventional study of Connected Catheter in Urinary Bladder, Neurogenic, sponsored by Spinal Singularity. Completed at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-26.
Sponsored by Spinal Singularity · Not applicable, Interventional, and Supportive care
Among 81 studies in Urinary Bladder, Neurogenic with a site in United States — 22 open to participants now, 30 under way, 1 of them phase 3. Urinary Bladder, Neurogenic · United States.
Among the 81 studies in Urinary Bladder, Neurogenic with a site in United States, this one is the 59th largest by enrollment of the 64 interventional ones, is one of 7 that started in 2018, is one of 31 with no phase, and was the 28th registered.
189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.
This study's enrollment of 5 is below the median of 39 across 125 interventional studies indexed under Urinary Bladder, Neurogenic.
Browse Urinary Bladder, Neurogenic studies →22 of the 81 studies in Urinary Bladder, Neurogenic with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 26 Urinary Bladder, Neurogenic studies recruiting now, 12 (46%) set no upper age limit and 9 (35%) stop at 75 or younger; 7 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →81 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 7 started in 2018.
Median enrollment 30 across the 64 interventional studies, 72 across the 17 observational. Of the 43 that completed or were terminated, 25 (58%) have results posted.
18 of 81 have an industry lead sponsor. The 10 most frequent:
Spinal Singularity is the lead sponsor of 5 studies on the registry; none are open to participants now.
Spinal Singularity has 4 studies filed under Urinary Bladder, Neurogenic — fewer than ten, so there is no comparison to draw.
11 of the studies in Urinary Bladder, Neurogenic with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03952299Phase 3University of California, DavisOxybutynin for Post-surgical Bladder Pain and Urgency | 2026-12-31 |
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT04128709Christopher CooperMeasurement of Bladder Pressure With a Novel External Device (Cystomanometer) - Home Use | 2026-12 |
| NCT03456089Christopher CooperMeasurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing | 2026-12-30 |
| NCT06337942University of California, Los AngelesDeceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study | 2027-01 |
Among the 81 studies in Urinary Bladder, Neurogenic with a site in United States, from their registry updates:
The objective of this study is to evaluate the safety and essential performance of the Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting, and during and extended period (up to 29 days) of home use.
The Connected Catheter (C2P) is a replaceable urinary prosthesis that is intended for use in male patients 18 years of age or older who have impaired bladder emptying due to neurogenic lower urinary tract dysfunction, and who are capable of operating the device in accordance with the provided instructions for use, or who have trained caregivers capable of doing the same. The device must be replaced every 29 days
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.
OR:
Must have urodynamic profile suitable for CIC, as assessed via urodynamics study within past 12 months (including bladder capacity > 200mL without uninhibited bladder contractions)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinical Feasibility Evaluation of Connected Catheter Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Device: Connected Catheter
The Connected Catheter is a fully internal, urethral-indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including neurogenic lower urinary tract dysfunction (NLUTD - e.g. due to spinal cord injury). The CoCath is a sterile, single-extended-use device that resides fully internally to the male lower urinary tract (urethra + bladder neck) for an intended service life of up to 29 days per Catheter.
Freedom from genito-urinary injury/trauma
Improved bladder management without injury or trauma to genito-urinary tract
Time frame: 29 Days
Successful Acute Performance- I
To evaluate successful retention of Connected Catheter and Void
Time frame: On the day of Connected Catheter Insertion
Successful Acute Performance -II
To evaluate successful bladder voiding with Connected Catheter
Time frame: On the day of Connected Catheter Insertion
Successful Acute Performance- III
To evaluate successful removal of Connected Catheter
Time frame: On the day of Connected Catheter Insertion
Successful Acute Performance- IV
To evaluate successful post-void sealing of Connected Catheter Valve
Time frame: On the day of Connected Catheter Insertion
Successful Home-Use Performance
Successful Home-Use using same measures as Acute Performance
Time frame: 29 days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jun 2018, 4 months.
Of 51 interventional studies with no phase under Urinary Bladder, Neurogenic, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 4 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 Jul 2018. You cannot join it, but the record below documents what was studied.
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Spinal Singularity