Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)

NCT01125722 | Completed Results

• 1 other identifier: CI-10-0001
• Study Type: interventional
• Target: 74
• Locations: 3 countries
• Sites: 11

Brief Summary

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.

Conditions

Overactive Bladder

Keywords

Urinary Incontinence; Overactive Bladder; Frequency; Urgency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in Mean Daily Voiding Frequency

  From baseline to Week 4 of active treatment

• Change in Mean Volume Per Void

  From Baseline to Week 4 of active treatment

• Change in Mean Urgency Episodes Per Day

  From Baseline to Week 4 of active treatment

• Change in Mean Overactive Bladder Symptom Composite Score

  From Baseline to Week 4 of active treatment

Study Arms (2)

Investigator Placement Group

ACTIVE COMPARATOR

Device: Non-invasive neurostimulation device

Subject Placement Group

ACTIVE COMPARATOR

Device: Non-invasive neurostimulation device

Interventions

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.

Investigator Placement Group

Eligibility Criteria

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

You may qualify if:

• Potential subjects must satisfy the following criteria in order to be enrolled in the study:
• Males and Females, at least 18 years of age
• Documented symptoms of idiopathic overactive bladder for at least 6 months
• Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug
• An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours
• An average of eight (8) or more voids per 24-hours, confirmed by the 3-day baseline voiding diary
• Demonstrated ability to adequately complete the 3-day baseline voiding diary
• Willing and capable of understanding and complying with all requirements of the protocol
• Signed Informed Consent to participate in the study after full discussion of the research nature of the treatment and its risks and benefits.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Urinary retention
• Clinically significant bladder outlet obstruction
• Morbidly obese, defined as having 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.
• History of 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
• Failure of previous neuromodulation therapy for overactive bladder
• Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months
• Any clinically significant congenital or acquired disorder of the urogenital tract (including denovo OAB following sub-urethral sling)
• Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ Prolapse Quantification (POPQ) criteria.
• Prior peri-urethral or transurethral bulking agent injections for bladder problems within the past 12 months.
• History of pelvic radiation therapy

Sponsors & Collaborators

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

Study Sites (11)

Medical Faculty Associates, The George Washington University

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

Location

William Beaumont Hospital - Department of Urology

Royal Oak, Michigan, 48073, United States

Location

AdvanceMed Research

Lawrenceville, New Jersey, 08648, United States

Location

Delaware Valley Urology, LLC

Mount Laurel, New Jersey, 08054, United States

Location

McKay Urology

Charlotte, North Carolina, 28207, United States

Location

Alliance Urology Specialists, P.A.

Greensboro, North Carolina, 27403, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Wheaton Franciscan Medical Group, Milwaukee Urogynecology

Wauwatosa, Wisconsin, 53226, United States

Location

Danderyd University Hospital

Stockholm, 182 88, Sweden

Location

Princess Anne Hospital

Southampton, S016 5YA, United Kingdom

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

Results Point of Contact

• Title: Michael Schwiers, Principal Biostatistician
• Organization: Ethicon Endo-Surgery

mschwier@its.jnj.com

513-337-1172

Study Officials

• Ashwani Monga, BM BS, MRCOG

  Princess Anne Hospital, Southampton, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 18, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 17, 2012
• Results First Posted: December 17, 2012

Record last verified: 2012-11

Locations

GB (1); SE (1); US (9)