An interventional study of TDOC 5Fr in Incontinence, Urge, sponsored by Laborie Medical Technologies Inc.. Completed at 2 sites in United States. Open to participants aged Up to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Laborie Medical Technologies Inc. · Not applicable, Interventional, and Other
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 135 studies in Urinary Incontinence, Urge with a site in United States — 19 open to participants now, 27 under way, none of them phase 3. Urinary Incontinence, Urge · United States.
Among the 135 studies in Urinary Incontinence, Urge with a site in United States, this one is the 86th largest by enrollment of the 119 interventional ones that give a count, is one of 15 that started in 2018, is one of 72 with no phase, and was the 62nd registered.
242 studies on the registry are indexed under Urinary Incontinence, Urge; 38 are open to participants now.
Browse Urinary Incontinence, Urge studies →19 of the 135 studies in Urinary Incontinence, Urge with a site in United States are open now. Recruiting first, the newest first:
Loma Linda University · Sites in United States
Ages 18–89
Axonics, Inc. · Sites in United States, Australia
Ages 18+
Neuspera Medical, Inc. · Sites in United States
Ages 22+
MedtronicNeuro · Sites in United States
Ages 18+
InMode MD Ltd. · Sites in United States
Ages 22–80 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Urinary Incontinence, Urge studies recruiting now, 18 (72%) set no upper age limit and 2 (8%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: Up to 12 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
135 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 10 · Phase 3 14 · Phase 4 19
First in 2003; this study’s year is marked. 15 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 28 is below the median of 86 across 190 interventional studies indexed under Urinary Incontinence, Urge.
Median enrollment 75 across the 119 interventional studies, 47 across the 15 observational. Of the 96 that completed or were terminated, 51 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
53 of 135 have an industry lead sponsor. The 10 most frequent:
Laborie Medical Technologies Inc. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Laborie Medical Technologies Inc. has 3 studies filed under Urinary Incontinence, Urge — fewer than ten, so there is no comparison to draw.
11 of the studies in Urinary Incontinence, Urge 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 |
|---|---|
| NCT06797245Medstar Health Research InstituteAPPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women | 2026-11 |
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT07335484Axonics, Inc.Aquarius Pilot Study to Evaluate the New Axonics Trial System | 2026-11 |
| NCT07247136Neuspera Medical, Inc.Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System | 2026-11 |
| NCT06186765Axonics, Inc.F15 Recharge Free Axonics SNM System Clinical Study | 2026-12 |
Add all 11 to your calendar (.ics) → With an account.
Among the 135 studies in Urinary Incontinence, Urge with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
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:
Device: TDOC 5Fr
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Safe in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger).
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.
Time frame: 2 months
The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Effective in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger).
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.
Time frame: 2 months
| Milestone | Urodynamics Arm |
|---|---|
| Started | 28 |
| Completed | 28 |
| Not completed | 0 |
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.
| Participants | Urodynamics Arm |
|---|---|
| The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Safe in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger). | 28 |
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.
| Participants | Urodynamics Arm |
|---|---|
| The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Effective in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger). | 28 |
Collected over Through study completion, an average of 5 to 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Urodynamics Arm | 0/28 (0%) | 0/28 (0%) | 4/28 (14.3%) |
| Event | Urodynamics Arm |
|---|---|
| DysuriaRenal and urinary disorders | 3/28 |
| HematocheziaGastrointestinal disorders | 1/28 |
| Age, Categorical(Participants) | Urodynamics Arm |
|---|---|
| <=18 years | 28 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Urodynamics Arm |
|---|---|
| Female | 10 |
| Male | 18 |
| Race and Ethnicity Not Collected(Participants) | Urodynamics Arm |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2018 to primary completion in Oct 2018, 8 months.
Results were first posted in Jun 2020, 1 year 7 months after primary completion.
Of 77 interventional studies with no phase under Urinary Incontinence, Urge, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 8 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 May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Laborie Medical Technologies Inc.