An interventional study of Gynecare TVT-SECUR system in Urinary Incontinence and Stress Urinary Incontinence, sponsored by Michigan Institution of Women's Health PC. Completed at 1 site in United States. Open to female participants aged 21 Years to 89 Years. Per ClinicalTrials.gov, last updated 2017-06-28.
Sponsored by Michigan Institution of Women's Health PC · Not applicable, Interventional, and Treatment
Among 291 studies in Urinary Incontinence with a site in United States — 31 open to participants now, 47 under way, 2 of them phase 3. Urinary Incontinence · United States.
Among the 291 studies in Urinary Incontinence with a site in United States, this one is the 143rd largest by enrollment of the 247 interventional ones that give a count, is one of 17 that started in 2008, is one of 143 with no phase, and was the 80th registered.
985 studies on the registry are indexed under Urinary Incontinence; 182 are open to participants now.
Browse Urinary Incontinence studies →31 of the 291 studies in Urinary Incontinence with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 18+ · Men only
Ohio State University · Sites in United States
Ages 18+ · Women only
University of Miami · Sites in United States
Ages 18+ · Women only
VA Office of Research and Development · Sites in United States
Women only
Bright Uro · Sites in United States
Ages 22+
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 110 Urinary Incontinence studies recruiting now, 61 (55%) set no upper age limit and 35 (32%) stop at 75 or younger; 15 take children under 18; 27 take healthy volunteers.
This study: 21 Years to 89 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
291 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 20 · Phase 2 23 · Phase 3 37 · Phase 4 35
First in 1993; this study’s year is marked. 17 started in 2008.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 50 is below the median of 66 across 740 interventional studies indexed under Urinary Incontinence.
Median enrollment 75 across the 247 interventional studies, 100 across the 43 observational. Of the 217 that completed or were terminated, 104 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
86 of 291 have an industry lead sponsor. The 10 most frequent:
Michigan Institution of Women's Health PC is the lead sponsor of 8 studies on the registry; none are open to participants now.
Michigan Institution of Women's Health PC has 1 study filed under Urinary Incontinence — fewer than ten, so there is no comparison to draw.
15 of the studies in Urinary Incontinence 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 |
|---|---|
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT04565925The University of Texas Medical Branch, GalvestonSildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries | 2026-12-01 |
| NCT07534696University of California, Los AngelesEvaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy | 2026-12-31 |
| NCT06226220University of ChicagoPercutaneous Nerve Evaluation Trial Time | 2026-12-31 |
| NCT06369922University of RochesterTENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence. | 2027-01-31 |
Add all 15 to your calendar (.ics) → With an account.
Among the 291 studies in Urinary Incontinence with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires.
This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.
The study will include 50 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.
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:
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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Device: Gynecare TVT-SECUR system
All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Also known as: TVT-S, Mid-urethral sling
Treatment Success Based on Patient Report on Validated Questionnaire
Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment.
Time frame: 24 months
Patient Satisfaction
Positive response to a satisfaction question
Time frame: 12 months
Recruitment period: October 2008-May 2009 at medical practice
| Milestone | Gynecare TVT-SECUR System |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment.
| Participants | Gynecare TVT-SECUR System |
|---|---|
| Treatment Success Based on Patient Report on Validated Questionnaire | 42 |
Positive response to a satisfaction question
| Participants | Gynecare TVT-SECUR System |
|---|---|
| Patient Satisfaction | 47 |
Collected over Adverse event data collected for 36 months following subject TVT-Secur procedure date.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gynecare TVT-SECUR System | 0/50 (0%) | 0/50 (0%) | 1/50 (2%) |
| Event | Gynecare TVT-SECUR System |
|---|---|
| Mesh ExposureProduct Issues | 1/50 |
| Age, Categorical(Participants) | Gynecare TVT-SECUR System |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 49 |
| >=65 years | 1 |
| Age, Continuous(years) | Gynecare TVT-SECUR System |
|---|---|
| Median | 46.7 ± 8.8 |
| Sex: Female, Male(Participants) | Gynecare TVT-SECUR System |
|---|---|
| Female | 50 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Gynecare TVT-SECUR System |
|---|---|
| White | 47 |
| Hispanic or Latino | 3 |
| Region of Enrollment(participants) | Gynecare TVT-SECUR System |
|---|---|
| United States | 50 |
The record gives a start of Oct 2008, a primary completion of Oct 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2017, 4 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. 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.
Michigan Institution of Women's Health PC