Urgency Urinary Incontinence
Conditions
Brief summary
The study is a single arm, prospective study of the safety and effectiveness of the Valencia Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with refractory urgency urinary incontinence.
Detailed description
This trial is a single arm, prospective study of the safety and effectiveness of eCoin tibial nerve stimulation in 25 subjects with refractory overactive bladder as defined by the American Urological Association.. The eCoin neuromodulation device will be implanted subcutaneously in the right or left leg of patients with urgency urinary incontinence. After a 4 week implant healing period, subjects will have their devices activated (turned ON). After 3 months of device therapy (occurring 4 months post-implant), the primary endpoint will be assessed. It is anticipated that subjects will reach the full therapeutic effect at approximately 3 months of therapy. Subjects will be followed for an additional 9 months to assess the safety of maintenance stimulation therapy with fewer sessions occurring during this time interval.
Interventions
DEVICEeCoin
Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.
Sponsors
Valencia Technologies Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women and men 18 years and older. 2. Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component, for at least 6 months (self-reported). 3. Individual has at least four urgency incontinence episodes on a three-day voiding diary with at least one episode per 24 hour time period 4. Individual with urinary frequency, defined as an average of greater than or equal to 8 times/24 hours (ie. a total of greater than or equal to 24 micturitions on a 3 day diary) 5. Individual is unresponsive to, inadequately responsive to, or intolerant of behavioral, rehabilitation, and pharmacologic therapy. 6. Individual is able to give his or her written, informed consent. 7. Individual is mentally competent and able to understand all study requirements. 8. Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire. 9. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists) for 2 weeks prior to screening. 10. The individual demonstrates a positive nerve integrity test.
Exclusion criteria
1. Individual has predominantly stress urinary incontinence 2. Individual has clinically significant bladder outlet obstruction. 3. Individual has clinically significant pelvic organ prolapse. 4. Individual has abnormal post void residual (i.e., greater than 150 cc). 5. Individual has clinically significant urethral stricture disease or bladder neck contracture 6. Individual has an active urinary tract infection at time of enrollment. 7. Individual has recurrent urinary tract infections defined as 4 or more UTI's per year. 8. Individual has morbid obesity. 9. Individual has had positive urine cytology or diagnosis of bladder or prostate cancer. 10. Individual has neurogenic bladder dysfunction. 11. Individual is taking an alpha-blocker for benign prostatic hyperplasia. 12. Individual is pregnant or intends to become pregnant during the study. 13. Patient is breast feeding or is less than 9-month post-partum. 14. Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis. 15. Individual has uncontrolled diabetes mellitus. 16. Individual has a cardiac pacemaker or implanted defibrillator. 17. Individual has been previously treated with sacral nerve stimulation. 18. Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment. 19. Individual has been treated with percutaneous tibial nerve stimulation within the previous 12 weeks prior to enrollment. 20. Individual requires regular Magnetic Resonance Imaging for other health care conditions. (ASK) 21. Individual has a clotting or bleeding disorder; antiplatelet and anticoagulant therapy may be continued or held at the discretion of the investigator 22. Individual has a clinically significant peripheral neuropathy. 23. Individual is neutropenic or immunocompromised.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incontinent Episodes | Baseline to three months post-activation. | The change in number of incontinence episodes from baseline to three months post-activation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System and Procedure Related AEs | Implantation to one month post-implantation. | Number of System and Procedure Related Adverse Events from implantation to one month post-implantation. |
| MAEs | Baseline to 3 months post-activation. | Number of all Major Adverse Events from baseline to 3 months post-activation. |
| Percentage of Responders | 3 months after activation | Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment |
Countries
New Zealand, United States
Participant flow
Recruitment details
Participants were recruited and enrolled from April 2017 to September 2017 (i.e. 5 months). The study took place at 7 urology/urogynecology clinics across the United States and New Zealand.
Pre-assignment details
Participants were required to complete a 2-week washout of all overactive bladder medications prior to baseline. After passing screening and baseline criteria, patients were enrolled. As this is a single-arm study, once participants were enrolled they were assigned to the intervention (eCoin).
Participants by arm
| Arm | Count |
|---|---|
| eCoin Treatment Arm receives implanted eCoin device and therapy is turned ON.
eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | MRI need | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | eCoin |
|---|---|
| Age, Continuous | 63.39 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Incontinence Quality of Life (I QoL) score | 45.39 score on a scale STANDARD_DEVIATION 20.4 |
| No. OAB medication at screening | 9 Participants |
| No. OAB medication history | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment New Zealand | 20 participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 1 Participants |
| Urgency urinary incontinence | 5.2 episodes/day STANDARD_DEVIATION 2.9 |
| Urinary incontinence | 5.9 episodes/day STANDARD_DEVIATION 3.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 16 / 46 |
| serious Total, serious adverse events | 3 / 46 |
Outcome results
Primary
Incontinent Episodes
The change in number of incontinence episodes from baseline to three months post-activation.
Time frame: Baseline to three months post-activation.
Population: Intent-to-treat
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| eCoin | Incontinent Episodes | -3.0 episodes/day | Standard Deviation 2.9 |
Secondary
MAEs
Number of all Major Adverse Events from baseline to 3 months post-activation.
Time frame: Baseline to 3 months post-activation.
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin | MAEs | 3 Adverse Events |
Secondary
Percentage of Responders
Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment
Time frame: 3 months after activation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| eCoin | Percentage of Responders | 32 Participants |
Secondary
System and Procedure Related AEs
Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.
Time frame: Implantation to one month post-implantation.
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin | System and Procedure Related AEs | 20 Adverse Events |