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| Name | Class |
|---|---|
| Novella Clinical | OTHER |
| Data & Inference, Inc. | INDUSTRY |
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The purpose of this study is to determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence.
While the precise cause of OAB symptoms (urge, frequency, incontinence) is not clear, most physicians and researchers accept the theory that a problem in the communication between the central nervous system and the bladder is a factor.
Research has shown that a process called neuromodulation of the nerves controlling the bladder can overcome this communication problem. In patients who have symptoms caused by the communication problem, neuromodulation has been clinically proven to eliminate or significantly reduce those symptoms. While neuromodulation has been previously achieved by implanting an electrode near the sacral nerve in the spine, the new concept under investigation within this protocol is believed to achieve a similar effect from adhesive electrodes placed on the skin over spinal nerves in the lower back.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigator Placement Group | Active Comparator |
| |
| Subject Placement Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive neurostimulation device | Device | Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Daily Urgency Incontinence Episodes | Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | From baseline to Week 4 of active treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Daily Voiding Frequency | Mean daily voiding frequency over 24 hours is based on a 3-day diary maintained by the subject. Voiding frequency is defined as the number of times a subject urinates. The number of voids over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. |
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Inclusion Criteria:
Potential subjects must satisfy the following criteria in order to be enrolled in the study:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Ashwani Monga, BM BS, MRCOG | Princess Anne Hospital, Southampton, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Faculty Associates, The George Washington University | Washington D.C. | District of Columbia | 20037 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigator Placement Group | Nerve stimulation patch is placed by the investigator at Weeks 1 through 4. |
| FG001 | Subject Placement Group | Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Non-invasive neurostimulation device | Device | Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the subject. |
|
| From baseline to Week 4 of active treatment |
| Change in Mean Volume Per Void | Mean volume per void (or amount of urine per urination) over 24 hours is based on a 3-day diary maintained by the subject. The volume of void (in milliliters) over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | From Baseline to Week 4 of active treatment |
| Change in Mean Urgency Episodes Per Day | Mean urgency episodes per day is based on a 3-day diary maintained by the subject. An urgency episode is identified by the subject as a case where they have a strong urge to urinate, i.e. difficulty controlling the bladder and thus are rushing to the bathroom. The number of urgency episodes over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | From Baseline to Week 4 of active treatment |
| Change in Mean Overactive Bladder Symptom Composite Score | The Overactive Bladder Symptom Composite is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence. It combines the Indevus Urgency Severity Scale for capture of urgency severity per toilet void with 24-hour frequency and urinary urge incontinence episodes. A complete reference for this validated measure can be found in teh Journal of Urology, Vol. 173, pgs 1639-1643, May 2005. The scale is specific to the instrument and lower scores represent an improvement in symptoms. The scale is a weighted average of each void a subject has. The weights are assigned as 0=no urgency, 1=mild, 2=moderate, 3=severe. The minimum score is 0, corresponding to no urgency in every void. There is no quantifiable upper limit since the scale is based on the number of voids per day, but there are reasonable upper limits. For example, if a subject had 15 voids in 1 day and all 15 were severe (=3), the Composite Score would be 45. Full details are in the reference above. | From Baseline to Week 4 of active treatment |
| William Beaumont Hospital - Department of Urology |
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| AdvanceMed Research | Lawrenceville | New Jersey | 08648 | United States |
| Delaware Valley Urology, LLC | Mount Laurel | New Jersey | 08054 | United States |
| McKay Urology | Charlotte | North Carolina | 28207 | United States |
| Alliance Urology Specialists, P.A. | Greensboro | North Carolina | 27403 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Wheaton Franciscan Medical Group, Milwaukee Urogynecology | Wauwatosa | Wisconsin | 53226 | United States |
| Danderyd University Hospital | Stockholm | 182 88 | Sweden |
| Princess Anne Hospital | Southampton | S016 5YA | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigator Placement Group | Nerve stimulation patch is placed by the investigator at Weeks 1 through 4. |
| BG001 | Subject Placement Group | Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4. |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Change in Mean Daily Urgency Incontinence Episodes | Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment. | Posted | Mean | Standard Deviation | number of incontinence episodes/24 hours | From baseline to Week 4 of active treatment |
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| Secondary | Change in Mean Daily Voiding Frequency | Mean daily voiding frequency over 24 hours is based on a 3-day diary maintained by the subject. Voiding frequency is defined as the number of times a subject urinates. The number of voids over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment. | Posted | Mean | Standard Deviation | number of voids per 24 hours | From baseline to Week 4 of active treatment |
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| Secondary | Change in Mean Volume Per Void | Mean volume per void (or amount of urine per urination) over 24 hours is based on a 3-day diary maintained by the subject. The volume of void (in milliliters) over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment. | Posted | Mean | Standard Deviation | mL | From Baseline to Week 4 of active treatment |
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| Secondary | Change in Mean Urgency Episodes Per Day | Mean urgency episodes per day is based on a 3-day diary maintained by the subject. An urgency episode is identified by the subject as a case where they have a strong urge to urinate, i.e. difficulty controlling the bladder and thus are rushing to the bathroom. The number of urgency episodes over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment. | Posted | Mean | Standard Deviation | number of urgency episodes per 24 hours | From Baseline to Week 4 of active treatment |
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| Secondary | Change in Mean Overactive Bladder Symptom Composite Score | The Overactive Bladder Symptom Composite is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence. It combines the Indevus Urgency Severity Scale for capture of urgency severity per toilet void with 24-hour frequency and urinary urge incontinence episodes. A complete reference for this validated measure can be found in teh Journal of Urology, Vol. 173, pgs 1639-1643, May 2005. The scale is specific to the instrument and lower scores represent an improvement in symptoms. The scale is a weighted average of each void a subject has. The weights are assigned as 0=no urgency, 1=mild, 2=moderate, 3=severe. The minimum score is 0, corresponding to no urgency in every void. There is no quantifiable upper limit since the scale is based on the number of voids per day, but there are reasonable upper limits. For example, if a subject had 15 voids in 1 day and all 15 were severe (=3), the Composite Score would be 45. Full details are in the reference above. | Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment. | Posted | Mean | Standard Deviation | scores on a scale | From Baseline to Week 4 of active treatment |
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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 | Investigator Placement Group | Nerve stimulation patch is placed by the investigator at Weeks 1 through 4. | 0 | 37 | 16 | 37 | ||
| EG001 | Subject Placement Group | Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4. | 0 | 37 | 14 | 37 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sensory/Peripheral Neurological Effect | Nervous system disorders | Systematic Assessment |
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| Urinary Tract Reactions | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers, Principal Biostatistician | Ethicon Endo-Surgery | 513-337-1172 | mschwier@its.jnj.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| 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 |
| D014555 | Urination Disorders |
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| >=65 years |
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| Male |
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| United Kingdom |
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| Sweden |
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| Participants |
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Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
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