Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate superiority of percutaneous posterior tibial nerve stimulation (PTNS) therapy compared to sham therapy for the treatment of patients with overall bladder (OAB) symptoms.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urgent PC | Active Comparator |
| |
| Sham / Placebo | No Intervention |
| 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 |
|---|---|---|
| The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis. | A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions. | 13 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gregory L. Davis, M.D., FACOG, Inc. | Chico | California | 95928 | United States | ||
| Greenwich Urological Associates, P.C. |
Not provided
Subjects were recruited by investigator sites with limited advertising
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Urgent PC | |
| FG001 | Sham / Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Greenwich |
| Connecticut |
| 06830 |
| United States |
| Specialists in Urology | Naples | Florida | 34102 | United States |
| Mercy Health Partners at the Lakes | Muskegon | Michigan | 49444 | United States |
| Beaumont Hospital | Royal Oak | Michigan | 48703 | United States |
| Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan | Grand Rapids | Minnesota | 49503 | United States |
| Uroplasty, Inc | Minnetonka | Minnesota | 55343 | United States |
| Beaumont Hospital | Royal Oak | Minnesota | 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 |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Virginia Urology | Richmond | Virginia | 23235 | United States |
| Athena Urology | Issaquah | Washington | 98027 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Urgent PC | |
| BG001 | Sham / Placebo | |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis. | A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions. | Intent to treat | Posted | Number | participants | 13 weeks |
|
|
|
|
Not provided
Not provided
Not provided
| 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 | 0 | 110 | 6 | 110 | |||
| EG001 | Sham / Placebo | 0 | 110 | 0 | 110 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ankle bruising | Surgical and medical procedures |
| |||
| discomfort at needle site | Surgical and medical procedures |
| |||
| bleeding at needle site | Surgical and medical procedures |
| |||
| tingling in leg | Surgical and medical procedures |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Holman, Cheif Operating Officer | Uroplasty, Inc. | 952-426-6143 | susan.holman@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 |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| No |
| Superiority or Other |