An interventional study of Connected Urinary Catheter in Urinary Retention, Neurogenic Bladder and Urologic Diseases, sponsored by Spinal Singularity. Terminated at 9 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by Spinal Singularity · Not applicable, Interventional, and Supportive care
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 71st largest by enrollment of the 81 interventional ones, is one of 6 that started in 2020, is one of 53 with no phase, and was the 53rd registered.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's enrollment of 9 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: 18 Years and older · male · 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. 6 started in 2020.
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:
Spinal Singularity is the lead sponsor of 5 studies on the registry; none are open to participants now.
Spinal Singularity has 5 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 Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.
Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.
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.
Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy
Must have stable urinary management history as determined by the Investigator
OR:
Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions)
Exclusion Criteria:
Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis)
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.
Device: Connected Urinary Catheter
Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Successful Bladder Emptying Using Connected Catheter
Rate of participants with successful voiding using the Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound A subject is considered a responder to the treatment if a minimum of 80% of their PVR values met the following criteria PVR is ≤ 50 mL OR PVR is ≤ baseline PVR with the standard of care catheter
Time frame: 35-40 days
Rate of device related Serious Adverse Events
Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
Time frame: 0 - 40 days
Successful device insertion, anchoring, and removal
Rate of Connected Catheter successfully inserted, anchored and removed
Time frame: 35-40 days
Successful sealing of the catheter valve
Rate of Connected Catheter valves sealed successfully
Time frame: 35-40 days
Quality of life improvement as measured by SCI-QOL Survey and other surveys
Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys
Time frame: 35-40 days
UTI occurrence rate
Rate of participants treated with the Connected Catheter reported with a urinary tract infection
Time frame: 35-40 days
Lower Urinary Tract injury rate
Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury
Time frame: 35-40 days
Ran from Oct 2020 to primary completion in Mar 2021, 5 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Spinal Singularity