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

NCT01369485 | Completed Results

• 1 other identifier: CI-10-0009
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 14

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).

Conditions

Overactive Bladder

Keywords

Urinary Incontinence; Overactive Bladder; Frequency; Urgency

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks (Randomized Phase) and 12 Months (Open Label)

• 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.

  12 weeks (Randomized Phase) and 12 Months (Open Label)

Secondary Outcomes (9)

• Measure Change in the Median of the Mean Urinary Frequency

  12 weeks and 12 Months

• Measure Median Change in Mean Volume Per Void

  12 weeks

• Measure Decrease in the Median Change From Baseline in Mean Urgency Episodes

  12 weeks

• Measure Improvement in the Median of the Mean OAB-Symptom Composite Score

  12 weeks

• Change in Median Total Health Related Quality of Life (HRQL) of OAB-q From Baseline (Screening) to Week 12

  12 Weeks (Randomized Phase) and 12 Months (Open Label).

Study Arms (2)

Active Treatment group

ACTIVE COMPARATOR

VERV™ System

Device: (VERV™ System)

Sham Treatment Group

SHAM COMPARATOR

Sham version of (VERV™ System)

Device: Sham version of (VERV™ System)

Interventions

(VERV™ System) DEVICE

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.

Also known as: Non-invasive neurostimulation device

Active Treatment group

Sham version of (VERV™ System) DEVICE

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.

Also known as: Inactive Non-invasive neurostimulation device

Sham Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead
• Novella Clinical: collaborator
• Data & Inference, Inc.: collaborator

Study Sites (14)

Arizona Urologic Specialists

Tucson, Arizona, 85712-5803, United States

Location

Tri Valley Urology Medical Group

Murrieta, California, 92562, United States

Location

GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Specialists in Urology

Naples, Florida, 34102, United States

Location

Urology Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Women's Health Institute of Illlinois, Ltd

Oak Lawn, Illinois, 60453, United States

Location

1st Urology, PSC dba Metropolitan Urology

Jeffersonville, Indiana, 47130, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

University Urology Associates

New York, New York, 10016, United States

Location

McKay Urology

Charlotte, North Carolina, 28207, United States

Location

Alliance Urology Specialists, P.A.

Greensboro, North Carolina, 27403, United States

Location

Carolina Urologic Research

Myrtle Beach, South Carolina, 29572, United States

Location

Integrity Medical Research

Mountlake Terrace, Washington, 98043, United States

Location

Wheaton Franciscan Medical Group - Milwaukee Urogynecology

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Limitations and Caveats

There was a higher than anticipated rate of patient withdrawals observed in both groups due to skin irritation.

Results Point of Contact

• Title: John Lombard, Manager Clinical Research
• Organization: Ethicon Surgical Care

Jlombar8@its.jnj.com

908 218 2877

Study Officials

• Michael Kennelly, MD

  McKay Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: June 9, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 11, 2014
• Results First Posted: September 11, 2014

Record last verified: 2014-09

Locations

US (14)