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Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder (Beacon)

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
(VERV™ System)
Sham version of (VERV™ System)
Sponsored by
Ethicon Endo-Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Urinary Incontinence, Overactive Bladder, Frequency, Urgency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and Females, at least 18 years of age
  • Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug (unless patient was contra-indicated for anti-cholinergic use)
  • Symptoms of overactive bladder for at least 6 months
  • An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours
  • Dexterity and ability to place and operate the device
  • Females of child-bearing capability agrees to use a reliable form of birth control for the duration of the trial
  • An average of eight (8) or more voids per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary
  • Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the baseline voiding diary
  • Signed and dated the IRB-approved Informed Consent document.

Exclusion Criteria:

  • Dysfunctional voiding symptoms unrelated to OAB, such as clinically significant bladder outlet obstruction, and urinary retention (pvr > 100 cc)
  • Morbidly obese, defined as having Body Mass Index (BMI) > 40 kg/m2
  • Stress predominant mixed urinary incontinence
  • Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and uncontrolled epilepsy.
  • Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months
  • Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 12 months
  • Any neuromodulation therapy for overactive bladder within the past 3 months
  • Failure to respond to previous neuromodulation therapy for overactive bladder
  • Leading edge of any vaginal prolapse is beyond hymenel ring.
  • Prior peri-urethral or transurethral bulking agent injections for bladder problems within the past 12 months.
  • Any skin conditions affecting treatment or assessment of the treatment sites
  • History of lower back surgery or injury that could impact placement of the patch, or where underlying scar tissue or nerve damage may impact treatment.
  • Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.), or any metallic implant in the lower back.
  • Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
  • Known latex allergies, or allergies or hypersensitivity to patch materials that will be in contact with the body (e.g., hydrogel, acrylic-based adhesive, polyurethane).
  • Uncontrolled diabetes and/or diabetes with peripheral neuropathy.
  • Current Urinary Tract Infection (UTI) or history of recurrent UTIs (>3 UTIs in the past year).
  • History of lower tract genitourinary malignancies within the last 6 months or any previous pelvic radiation.
  • Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study.

Sites / Locations

  • Arizona Urologic Specialists
  • Tri Valley Urology Medical Group
  • GW Medical Faculty Associates
  • Specialists in Urology
  • Urology Center of Florida
  • Women's Health Institute of Illlinois, Ltd
  • 1st Urology, PSC dba Metropolitan Urology
  • William Beaumont Hospital
  • University Urology Associates
  • McKay Urology
  • Alliance Urology Specialists, P.A.
  • Carolina Urologic Research
  • Integrity Medical Research
  • Wheaton Franciscan Medical Group - Milwaukee Urogynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Treatment group

Sham Treatment Group

Arm Description

VERV™ System

Sham version of (VERV™ System)

Outcomes

Primary Outcome Measures

Evaluate Proportion of Responders Based on the Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups
The primary objective of the randomized phase of the study is to evaluate the 12 week change from baseline in mean urgency (urinary) incontinence episodes (leaks) between the active and sham treatment groups. The mean of the number of urinary incontinence episodes over 24 hours" is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary). The primary objective of the open label phase of the study is to evaluate and confirm the continued efficacy of the VERV™ System for long-term use. The primary objective was assessed with rate of responders, where responder was defined as a subject who achieved a decrease of ≥50% in mean urgency urinary incontinence episodes at 12 weeks compared to baseline.
Evaluate the Median Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups
The primary objective of the randomized phase of the study is to evaluate the 12 week and 12 month median change from baseline in mean urgency (urinary) incontinence episodes (leaks) between treatment groups. The mean of the number of urinary incontinence episodes over 24 hours" is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary). Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov - Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians.

Secondary Outcome Measures

Measure Change in the Median of the Mean Urinary Frequency
Evaluate the 12 week change from baseline in median urinary frequency between the active and sham treatment groups. Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov - Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians.
Measure Median Change in Mean Volume Per Void
Evaluate the 12 week median change from baseline in mean volume (ml) per void between the active and sham treatment groups
Measure Decrease in the Median Change From Baseline in Mean Urgency Episodes
Evaluate the 12 week change from baseline in median for mean number of urgency episodes between the active and sham treatment groups. Patients were required to complete seven 3-day voiding diaries throughout the course of the study. The voiding diary collected the following information: amount voided (in ml); urgency associated with each toileted void , approximate time of leak, and presence of urge preceding leak.The mean number of urgency episodes over 24 hours was then calculated for each patient during the observation period. The change in median for the mean of the number of urgency episodes over 24 hours) for each treatment group was then calculated. Distribution of changes from baseline were assessed prospectively using the Kolmogorov - Smirnoff test. The Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians.
Measure Improvement in the Median of the Mean OAB-Symptom Composite Score
OAB Symptom Composite Score (OAB-SCS) is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence combining the Indevus Urgency Severity Scale (IUSS) for capture of urgency severity per toilet void with 24-hour frequency and UUI episodes. IUSS Score/void and/or UUI is assigned an OAB-SCS Point/Void: 0(none)=1, 1(mild/easily tolerated)=2, 2(moderate discomfort interfering with activities)=3, 3(severe/extreme urgency discomfort that abruptly stopped all activity or tasks)=4, UUI without void=5. Overall OAB-SCS Score is calculated for each day by multiplying the OAB-SCS Points/Void and/or UUIs by the number of events meeting criteria and adding the individual scores together. The minimum overall OAB-SCS score in a 24 hour period would be a 1 (representing a single mild void with a OAB -SCS Point/Void score of 0). The score would increase based upon the number voids/events and overall severity each event. Medians calculated for each treatment group.
Change in Median Total Health Related Quality of Life (HRQL) of OAB-q From Baseline (Screening) to Week 12
The OAB-q is validated to measure symptom bother and life impact due to OAB. It consists of an 8-item Bother Scale to assess individual symptoms and a 25-item HRQL scale that in turn consists of 4 subscales (coping-8 items, concern-7 items, sleep-5 items and social-5 items) to assess impact on life. Responses for each item in the Bother Scale range from 1 (bothered not at all by the symptom) to 6 (Bothered A Very Great Deal). Scores are then added generating an overall Bother Score (severity) ranging from 8 to 48. For HRQL, individual responses range between 1-None of the Time to a 6-All of the Time. Subscale scores range from 8-48 (coping) 7-42 (concern), 5-30 (sleep) and 5-30 (social). Subscale scores are then added to generate the HRQL ranging between 25-150. Raw HRQL scores are transformed for standardization purposes as follows: ((Highest Possible Score-Actual Raw Score)/Range of Scores)*1 00 so that scores could range from 0 (All of the Time) to 100 (None of the Time).
Change in Patient Perception of Bladder Condition (PPBC) From Baseline (Screening Period) to Week 12 as Defined as an Improvement in Severity.
PPBC is a 6-point scale (from 'no problems at all' to 'many severe problems') describing the problem level of the bladder condition at that moment. Improvement is defined as a reduction in the number and/or severity of observed problems.
Assessment of Treatment Benefit Scale (TBS)
TBS is a patient-reported outcome comprised of a 4-point scale of checkboxes to describe the change in condition during treatment (greatly improved to worsened). Improvement was defined as a change in the patient's assessment of overall condition to improved or greatly improved over the course of treatment. Analysis was based upon the number of patients who reported an improvement in condition.
Assessment of Improvement as Measure by Overactive Bladder Satisfaction With Treatment Questionnaire (OAB-SAT)
Overall satisfaction with treatment was assessed (OAB-SAT-q) an 11 question list with multiple scaled checkboxes to allow the subject to rate the treatment with regard to satisfaction, bother from side effects, treatment endorsement, and convenience.
Change Clinical Global Impressions at 12 Weeks
CGI is an Investigator assessment, which rates the severity of illness at baseline on a scale of 1 (normal, not ill at all) to 7 (Amongst the most extremely ill patients), and then rates improvement at 12 weeks on a scale of 1 (very much improved) to 10 (very much worse). The analysis was based upon the number of patients that "much" and "very much" improved.

Full Information

First Posted
May 24, 2011
Last Updated
September 4, 2014
Sponsor
Ethicon Endo-Surgery
Collaborators
Novella Clinical, Data & Inference, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01369485
Brief Title
Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder
Acronym
Beacon
Official Title
Multi-center, Prospective, Randomized, Double-blind, Sham-controlled Clinical Study to Evaluate Safety and Effectiveness of a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Subjects With Overactive Bladder (OAB)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon Endo-Surgery
Collaborators
Novella Clinical, Data & Inference, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the change from baseline between the active and sham treatment groups in the treatment of urgency (urinary) incontinence episodes (leaks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Urinary Incontinence, Overactive Bladder, Frequency, Urgency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment group
Arm Type
Active Comparator
Arm Description
VERV™ System
Arm Title
Sham Treatment Group
Arm Type
Sham Comparator
Arm Description
Sham version of (VERV™ System)
Intervention Type
Device
Intervention Name(s)
(VERV™ System)
Other Intervention Name(s)
Non-invasive neurostimulation device
Intervention Description
Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
Intervention Type
Device
Intervention Name(s)
Sham version of (VERV™ System)
Other Intervention Name(s)
Inactive Non-invasive neurostimulation device
Intervention Description
Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
Primary Outcome Measure Information:
Title
Evaluate Proportion of Responders Based on the Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups
Description
The primary objective of the randomized phase of the study is to evaluate the 12 week change from baseline in mean urgency (urinary) incontinence episodes (leaks) between the active and sham treatment groups. The mean of the number of urinary incontinence episodes over 24 hours" is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary). The primary objective of the open label phase of the study is to evaluate and confirm the continued efficacy of the VERV™ System for long-term use. The primary objective was assessed with rate of responders, where responder was defined as a subject who achieved a decrease of ≥50% in mean urgency urinary incontinence episodes at 12 weeks compared to baseline.
Time Frame
12 weeks (Randomized Phase) and 12 Months (Open Label)
Title
Evaluate the Median Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups
Description
The primary objective of the randomized phase of the study is to evaluate the 12 week and 12 month median change from baseline in mean urgency (urinary) incontinence episodes (leaks) between treatment groups. The mean of the number of urinary incontinence episodes over 24 hours" is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary). Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov - Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians.
Time Frame
12 weeks (Randomized Phase) and 12 Months (Open Label)
Secondary Outcome Measure Information:
Title
Measure Change in the Median of the Mean Urinary Frequency
Description
Evaluate the 12 week change from baseline in median urinary frequency between the active and sham treatment groups. Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov - Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians.
Time Frame
12 weeks and 12 Months
Title
Measure Median Change in Mean Volume Per Void
Description
Evaluate the 12 week median change from baseline in mean volume (ml) per void between the active and sham treatment groups
Time Frame
12 weeks
Title
Measure Decrease in the Median Change From Baseline in Mean Urgency Episodes
Description
Evaluate the 12 week change from baseline in median for mean number of urgency episodes between the active and sham treatment groups. Patients were required to complete seven 3-day voiding diaries throughout the course of the study. The voiding diary collected the following information: amount voided (in ml); urgency associated with each toileted void , approximate time of leak, and presence of urge preceding leak.The mean number of urgency episodes over 24 hours was then calculated for each patient during the observation period. The change in median for the mean of the number of urgency episodes over 24 hours) for each treatment group was then calculated. Distribution of changes from baseline were assessed prospectively using the Kolmogorov - Smirnoff test. The Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians.
Time Frame
12 weeks
Title
Measure Improvement in the Median of the Mean OAB-Symptom Composite Score
Description
OAB Symptom Composite Score (OAB-SCS) is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence combining the Indevus Urgency Severity Scale (IUSS) for capture of urgency severity per toilet void with 24-hour frequency and UUI episodes. IUSS Score/void and/or UUI is assigned an OAB-SCS Point/Void: 0(none)=1, 1(mild/easily tolerated)=2, 2(moderate discomfort interfering with activities)=3, 3(severe/extreme urgency discomfort that abruptly stopped all activity or tasks)=4, UUI without void=5. Overall OAB-SCS Score is calculated for each day by multiplying the OAB-SCS Points/Void and/or UUIs by the number of events meeting criteria and adding the individual scores together. The minimum overall OAB-SCS score in a 24 hour period would be a 1 (representing a single mild void with a OAB -SCS Point/Void score of 0). The score would increase based upon the number voids/events and overall severity each event. Medians calculated for each treatment group.
Time Frame
12 weeks
Title
Change in Median Total Health Related Quality of Life (HRQL) of OAB-q From Baseline (Screening) to Week 12
Description
The OAB-q is validated to measure symptom bother and life impact due to OAB. It consists of an 8-item Bother Scale to assess individual symptoms and a 25-item HRQL scale that in turn consists of 4 subscales (coping-8 items, concern-7 items, sleep-5 items and social-5 items) to assess impact on life. Responses for each item in the Bother Scale range from 1 (bothered not at all by the symptom) to 6 (Bothered A Very Great Deal). Scores are then added generating an overall Bother Score (severity) ranging from 8 to 48. For HRQL, individual responses range between 1-None of the Time to a 6-All of the Time. Subscale scores range from 8-48 (coping) 7-42 (concern), 5-30 (sleep) and 5-30 (social). Subscale scores are then added to generate the HRQL ranging between 25-150. Raw HRQL scores are transformed for standardization purposes as follows: ((Highest Possible Score-Actual Raw Score)/Range of Scores)*1 00 so that scores could range from 0 (All of the Time) to 100 (None of the Time).
Time Frame
12 Weeks (Randomized Phase) and 12 Months (Open Label).
Title
Change in Patient Perception of Bladder Condition (PPBC) From Baseline (Screening Period) to Week 12 as Defined as an Improvement in Severity.
Description
PPBC is a 6-point scale (from 'no problems at all' to 'many severe problems') describing the problem level of the bladder condition at that moment. Improvement is defined as a reduction in the number and/or severity of observed problems.
Time Frame
12 Weeks (Randomized Phase) and 12 Months (Open Label Phase)
Title
Assessment of Treatment Benefit Scale (TBS)
Description
TBS is a patient-reported outcome comprised of a 4-point scale of checkboxes to describe the change in condition during treatment (greatly improved to worsened). Improvement was defined as a change in the patient's assessment of overall condition to improved or greatly improved over the course of treatment. Analysis was based upon the number of patients who reported an improvement in condition.
Time Frame
12 Weeks
Title
Assessment of Improvement as Measure by Overactive Bladder Satisfaction With Treatment Questionnaire (OAB-SAT)
Description
Overall satisfaction with treatment was assessed (OAB-SAT-q) an 11 question list with multiple scaled checkboxes to allow the subject to rate the treatment with regard to satisfaction, bother from side effects, treatment endorsement, and convenience.
Time Frame
12 weeks
Title
Change Clinical Global Impressions at 12 Weeks
Description
CGI is an Investigator assessment, which rates the severity of illness at baseline on a scale of 1 (normal, not ill at all) to 7 (Amongst the most extremely ill patients), and then rates improvement at 12 weeks on a scale of 1 (very much improved) to 10 (very much worse). The analysis was based upon the number of patients that "much" and "very much" improved.
Time Frame
12 weeks (Randomized Phase) and 12 Months (Open Label Phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and Females, at least 18 years of age Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug (unless patient was contra-indicated for anti-cholinergic use) Symptoms of overactive bladder for at least 6 months An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours Dexterity and ability to place and operate the device Females of child-bearing capability agrees to use a reliable form of birth control for the duration of the trial An average of eight (8) or more voids per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the baseline voiding diary Signed and dated the IRB-approved Informed Consent document. Exclusion Criteria: Dysfunctional voiding symptoms unrelated to OAB, such as clinically significant bladder outlet obstruction, and urinary retention (pvr > 100 cc) Morbidly obese, defined as having Body Mass Index (BMI) > 40 kg/m2 Stress predominant mixed urinary incontinence Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and uncontrolled epilepsy. Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 12 months Any neuromodulation therapy for overactive bladder within the past 3 months Failure to respond to previous neuromodulation therapy for overactive bladder Leading edge of any vaginal prolapse is beyond hymenel ring. Prior peri-urethral or transurethral bulking agent injections for bladder problems within the past 12 months. Any skin conditions affecting treatment or assessment of the treatment sites History of lower back surgery or injury that could impact placement of the patch, or where underlying scar tissue or nerve damage may impact treatment. Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.), or any metallic implant in the lower back. Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study. Known latex allergies, or allergies or hypersensitivity to patch materials that will be in contact with the body (e.g., hydrogel, acrylic-based adhesive, polyurethane). Uncontrolled diabetes and/or diabetes with peripheral neuropathy. Current Urinary Tract Infection (UTI) or history of recurrent UTIs (>3 UTIs in the past year). History of lower tract genitourinary malignancies within the last 6 months or any previous pelvic radiation. Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kennelly, MD
Organizational Affiliation
McKay Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Urologic Specialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712-5803
Country
United States
Facility Name
Tri Valley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
GW Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Specialists in Urology
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Urology Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Women's Health Institute of Illlinois, Ltd
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
1st Urology, PSC dba Metropolitan Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
McKay Urology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Alliance Urology Specialists, P.A.
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Carolina Urologic Research
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Integrity Medical Research
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Wheaton Franciscan Medical Group - Milwaukee Urogynecology
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder

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