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

This study has been completed.
Sponsor:
Collaborators:
Novella Clinical, Inc.
Data & Inference, Inc.
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT01369485
First received: May 24, 2011
Last updated: September 4, 2014
Last verified: September 2014
Results First Received: April 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Overactive Bladder
Interventions: Device: (VERV™ System)
Device: Sham version of (VERV™ System)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After informed consent was obtained, subjects had a 10-day washout period from any anti-cholinergic medications prescribed for treatment of overactive bladder prior to initiating study treatment.

Reporting Groups
  Description
Randomized Active Treatment Group

VERV™ System

(VERV™ System): 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.

Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months.

Randomized Sham Treatment Group

Sham version of (VERV™ System)

Sham version of (VERV™ System): 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.

Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months.


Participant Flow for 2 periods

Period 1:   Randomized Phase (Day 0 to Week 12)
    Randomized Active Treatment Group     Randomized Sham Treatment Group  
STARTED     80     83  
COMPLETED     57     66  
NOT COMPLETED     23     17  
Adverse Event                 7                 5  
Withdrawal by Subject                 12                 8  
Lost to Follow-up                 2                 4  
expired patches                 2                 0  

Period 2:   Open Label Phase (Week 12 to Month 12)
    Randomized Active Treatment Group     Randomized Sham Treatment Group  
STARTED     57     66  
COMPLETED     24     26  
NOT COMPLETED     33     40  
Adverse Event                 11                 9  
Lost to Follow-up                 2                 3  
Physician Decision                 3                 4  
Withdrawal by Subject                 17                 20  
Death                 0                 1  
1 pacemaker, 1 noncompliance, 1 hospice                 0                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat population

Reporting Groups
  Description
Active Treatment Group

VERV™ System

(VERV™ System): 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.

Sham Treatment Group

Sham version of (VERV™ System)

Sham version of (VERV™ System): 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.

Total Total of all reporting groups

Baseline Measures
    Active Treatment Group     Sham Treatment Group     Total  
Number of Participants  
[units: participants]
  80     83     163  
Age  
[units: years]
Mean ± Standard Deviation
  60.8  ± 14.3     62.4  ± 13.8     61.6  ± 14.1  
Gender  
[units: participants]
     
Female     70     68     138  
Male     10     15     25  
Race/Ethnicity, Customized  
[units: participants]
     
Native American     1     1     2  
Asian     1     2     3  
African American     11     12     23  
Caucasian     65     66     131  
Other     2     2     4  
Region of Enrollment  
[units: participants]
     
United States     80     83     163  



  Outcome Measures
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1.  Primary:   Evaluate Proportion of Responders Based on the Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups   [ Time Frame: 12 weeks (Randomized Phase) and 12 Months (Open Label) ]

2.  Primary:   Evaluate the Median Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups   [ Time Frame: 12 weeks (Randomized Phase) and 12 Months (Open Label) ]

3.  Secondary:   Measure Change in the Median of the Mean Urinary Frequency   [ Time Frame: 12 weeks and 12 Months ]

4.  Secondary:   Measure Median Change in Mean Volume Per Void   [ Time Frame: 12 weeks ]

5.  Secondary:   Measure Decrease in the Median Change From Baseline in Mean Urgency Episodes   [ Time Frame: 12 weeks ]

6.  Secondary:   Measure Improvement in the Median of the Mean OAB-Symptom Composite Score   [ Time Frame: 12 weeks ]

7.  Secondary:   Change in Median Total Health Related Quality of Life (HRQL) of OAB-q From Baseline (Screening) to Week 12   [ Time Frame: 12 Weeks (Randomized Phase) and 12 Months (Open Label). ]

8.  Secondary:   Change in Patient Perception of Bladder Condition (PPBC) From Baseline (Screening Period) to Week 12 as Defined as an Improvement in Severity.   [ Time Frame: 12 Weeks (Randomized Phase) and 12 Months (Open Label Phase) ]

9.  Secondary:   Assessment of Treatment Benefit Scale (TBS)   [ Time Frame: 12 Weeks ]

10.  Secondary:   Assessment of Improvement as Measure by Overactive Bladder Satisfaction With Treatment Questionnaire (OAB-SAT)   [ Time Frame: 12 weeks ]

11.  Secondary:   Change Clinical Global Impressions at 12 Weeks   [ Time Frame: 12 weeks (Randomized Phase) and 12 Months (Open Label Phase) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There was a higher than anticipated rate of patient withdrawals observed in both groups due to skin irritation.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Lombard, Manager Clinical Research
Organization: Ethicon Surgical Care
phone: 908 218 2877
e-mail: Jlombar8@its.jnj.com


No publications provided


Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT01369485     History of Changes
Other Study ID Numbers: CI-10-0009
Study First Received: May 24, 2011
Results First Received: April 14, 2014
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board