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The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urgent PC treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urgent PC Neuromodulation System | 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 |
|---|---|---|
| Frequency of Voids at 12 Weeks | To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries. | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urge Incontinence Episodes at 12 Weeks | 12 weeks | |
| Volume Voided at 12 Weeks | 12 weeks | |
| OAB Quality of Life at 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan O'Toole | Uroplasty, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uroplasty, Inc | Minnetonka | Minnesota | 55343 | United States |
After 12 weekly PTNS treatments, 35 patients were considered responders (reporting of "Moderately" or "Markedly" improved on the Global Response Assessment (GRA))and allowed to continue in the trial through 12 months.
Subjects were recruited by investigator sites with limited advertising
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| ID | Title | Description |
|---|---|---|
| FG000 | Urgent PC Treatment Arm | 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). |
| FG001 | 4mg Daily Tolterodine | 90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 12 Weeks PTNS vs. Drug |
| |||||||||||||
| Continued PTNS Through 12 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Urgent PC Treatment Arm | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Frequency of Voids at 12 Weeks | To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries. | Posted | Mean | Standard Deviation | Voids/day | Baseline to 12 weeks |
|
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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 Treatment Arm | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Manager | Uroplasty, Inc | 952-426-6153 | megan.otoole@uroplasty.com |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
| Tolterodine | Drug |
|
| 12 weeks |
| Known Side Effects Through 12 Weeks | 12 weeks |
| NOT COMPLETED |
|
| 4mg Daily Tolterodine |
90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA) |
|
|
| Secondary | Urge Incontinence Episodes at 12 Weeks | Not Posted | 12 weeks |
| Secondary | Volume Voided at 12 Weeks | Not Posted | 12 weeks |
| Secondary | OAB Quality of Life at 12 Weeks | Not Posted | 12 weeks |
| Secondary | Known Side Effects Through 12 Weeks | Not Posted | 12 weeks |
| 0 |
| 50 |
| 6 |
| 50 |
| EG001 | 4mg Daily Tolterodine | 90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA) | 0 | 50 | 4 | 50 |
| Leg cramp | Surgical and medical procedures |
|
| Redness/Inflammation at needle site | Surgical and medical procedures |
|
| Pressure/discomfort at needle site | Surgical and medical procedures |
|
| Vasovagal response to needle placement | Surgical and medical procedures |
|
| Jolt felt in leg during treatment | Surgical and medical procedures |
|
| Blurred Vision | Surgical and medical procedures |
|
| Headache | Surgical and medical procedures |
|
| Constipation | Surgical and medical procedures |
|
| Increase urgency/frequency | Surgical and medical procedures |
|
| Severe Dizziness | Surgical and medical procedures |
|
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| 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 |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |