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This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urgent PC | Active Comparator | The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urgent PC | Device | The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline | The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse). | 36 months total |
| Measure | Description | Time Frame |
|---|---|---|
| GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence. | every three months for 36 months | |
| Change in OAB-q and SF-36 Questionnaires. | every three months for 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Peters, MD | Beaumont Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gregory L. Davis, M.D., FACOG, Inc. | Chico | California | 95928 | United States | ||
| Greenwich Urological Associates, P.C. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22674493 | Derived | Peters KM, Carrico DJ, MacDiarmid SA, Wooldridge LS, Khan AU, McCoy CE, Franco N, Bennett JB. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn. 2013 Jan;32(1):24-9. doi: 10.1002/nau.22266. Epub 2012 Jun 5. |
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Subjects were recruited by investigator sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Urgent PC | The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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|
| Change in Voiding Diary Parameters. | every three months for 36 months |
| Greenwich |
| Connecticut |
| 06830 |
| United States |
| Specialists in Urology | Naples | Florida | 34102 | United States |
| Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan | Grand Rapids | Michigan | 49503 | United States |
| Mercy Health Partners at the Lakes | Muskegon | Michigan | 49444 | United States |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Urology Health Center, PC | Fremont | Nebraska | 68025 | United States |
| Capital Region Urological Surgeons, PLLC | Albany | New York | 12208 | United States |
| Central Missouri Women's Healthcare, LLC | White Plains | New York | 10604 | United States |
| Alliance Urology Specialists | Greensboro | North Carolina | 27403 | United States |
| Virginia Urology | Richmond | Virginia | 23235 | United States |
| Athena Urology | Issaquah | Washington | 98027 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Urgent PC | The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline | The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse). | Posted | Number | 95% Confidence Interval | Proportion of Patients | 36 months total |
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| Secondary | GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence. | Not Posted | every three months for 36 months | |||||||||||||||||||||||||||||||||
| Secondary | Change in OAB-q and SF-36 Questionnaires. | Not Posted | every three months for 36 months | |||||||||||||||||||||||||||||||||
| Secondary | Change in Voiding Diary Parameters. | Not Posted | every three months for 36 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Urgent PC | The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). | 0 | 50 | 1 | 50 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding at needle site | Surgical and medical procedures |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Manager | Uroplasty, Inc | 952-426-6153 | megan.otoole@uroplasty.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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