Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
Sponsor
Valencia Technologies Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03556891
Collaborator
(none)
133
15
1
43.2
8.9
0.2
Study Details
Study Description
Brief Summary
This trial is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient reported-outcomes through 48 weeks of eCoinTM therapy or 52 weeks of implantation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
133 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)
Actual Study Start Date
:
Sep 4, 2018
Actual Primary Completion Date
:
Apr 12, 2020
Anticipated Study Completion Date
:
Apr 12, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: eCoin Tibial Nerve Stimulation
|
Device: eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. [48 weeks after device activation.]
Responder rate
- Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. [52 weeks after implantation.]
All adverse events will be reported in all patients who were implanted 12 months after implantation.
Secondary Outcome Measures
- Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events. [24 weeks after device activation]
All adverse events will be reported.
- Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. [24 weeks after device activation]
Moderate-term effectiveness data, responder rate
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Primary Inclusion Criteria:
-
Women and men between 18 and 80 years old.
-
Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months.
-
Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).
-
Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation.
Primary Exclusion Criteria:
-
Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.
-
Clinically significant bladder outlet obstruction.
-
Clinically significant pelvic organ prolapse beyond the hymenal ring.
-
Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente | Downey | California | United States | 90242 |
| 2 | Sequoia Urology Center | Redwood City | California | United States | 94062 |
| 3 | Kaiser Permanente | San Diego | California | United States | 92110 |
| 4 | Sansum Clinic | Santa Barbara | California | United States | 93105 |
| 5 | SurgOne PC | Englewood | Colorado | United States | 80113 |
| 6 | Urology Associates of Norwalk | Norwalk | Connecticut | United States | 06850 |
| 7 | Florida Bladder Institute | Naples | Florida | United States | 34109 |
| 8 | North Shore Medical Group | Skokie | Illinois | United States | 60076 |
| 9 | UnityPoint Clinic | Waterloo | Iowa | United States | 50703 |
| 10 | Chesapeake Urology | Owings Mills | Maryland | United States | 21117 |
| 11 | Adult & Pediatric Urology | Omaha | Nebraska | United States | 68114 |
| 12 | Manhattan Medical Research | New York | New York | United States | 10016 |
| 13 | Alliance Urology Specialists | Greensboro | North Carolina | United States | 27403 |
| 14 | The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute) | Allentown | Pennsylvania | United States | 18103 |
| 15 | South Carolina OB/GYN | Columbia | South Carolina | United States | 29201 |
Sponsors and Collaborators
- Valencia Technologies Corporation
Investigators
- Principal Investigator: Scott MacDiarmid, MD, Alliance Urology
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Valencia Technologies Corporation
ClinicalTrials.gov Identifier:
NCT03556891
Other Study ID Numbers:
- 111-3281
First Posted:
Jun 14, 2018
Last Update Posted:
Jul 30, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | eCoin Tibial Nerve Stimulation |
|---|---|
| Arm/Group Description | eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. |
| Period Title: Overall Study | |
| STARTED | 133 |
| COMPLETED | 120 |
| NOT COMPLETED | 13 |
Baseline Characteristics
| Arm/Group Title | eCoin Tibial Nerve Stimulation |
|---|---|
| Arm/Group Description | eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. |
| Overall Participants | 133 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
64.0
(11.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
131
98.5%
|
| Male |
2
1.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
22
16.5%
|
| Not Hispanic or Latino |
101
75.9%
|
| Unknown or Not Reported |
10
7.5%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
3
2.3%
|
| Asian |
2
1.5%
|
| Native Hawaiian or Other Pacific Islander |
1
0.8%
|
| Black or African American |
6
4.5%
|
| White |
112
84.2%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
9
6.8%
|
| Region of Enrollment (participants) [Number] | |
| United States |
133
100%
|
| Urgency Urinary Incontinence (UUI) Episodes (episodes/day) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [episodes/day] |
4.32
(3.08)
|
| Urinary Voids (voids/day) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [voids/day] |
13.06
(2.67)
|
| Urgency Episodes (episodes/day) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [episodes/day] |
8.20
(3.65)
|
| Nocturia Episodes (episodes/day) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [episodes/day] |
2.54
(1.04)
|
| Overactive Bladder Questionnaire (OABq) - Short Form (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
66.1
(19.6)
|
| Overactive Bladder Questionnaire (OABq) - Health Related Quality of Life (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
45.7
(22.5)
|
Outcome Measures
| Title | Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |
|---|---|
| Description | Responder rate |
| Time Frame | 48 weeks after device activation. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat |
| Arm/Group Title | eCoin Tibial Nerve Stimulation |
|---|---|
| Arm/Group Description | eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. |
| Measure Participants | 132 |
| Number (95% Confidence Interval) [percentage of responders] |
68
|
| Title | Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. |
|---|---|
| Description | All adverse events will be reported in all patients who were implanted 12 months after implantation. |
| Time Frame | 52 weeks after implantation. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat plus subject with a baseline UUI of 0. |
| Arm/Group Title | eCoin Tibial Nerve Stimulation |
|---|---|
| Arm/Group Description | eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. |
| Measure Participants | 133 |
| Number [percentage of participants] |
16
12%
|
| Title | Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events. |
|---|---|
| Description | All adverse events will be reported. |
| Time Frame | 24 weeks after device activation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat plus subject with a baseline UUI of 0. |
| Arm/Group Title | eCoin Tibial Nerve Stimulation |
|---|---|
| Arm/Group Description | eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. |
| Measure Participants | 133 |
| Number [percentage of participants] |
14
10.5%
|
| Title | Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |
|---|---|
| Description | Moderate-term effectiveness data, responder rate |
| Time Frame | 24 weeks after device activation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat |
| Arm/Group Title | eCoin Tibial Nerve Stimulation |
|---|---|
| Arm/Group Description | eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. |
| Measure Participants | 132 |
| Number (95% Confidence Interval) [percentage of responders] |
69
|
Adverse Events
| Time Frame | 52 weeks post-implantation | |
|---|---|---|
| Adverse Event Reporting Description | The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF. | |
| Arm/Group Title | eCoin Tibial Nerve Stimulation | |
| Arm/Group Description | eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. | |
All Cause Mortality |
||
| eCoin Tibial Nerve Stimulation | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/133 (0.8%) | |
Serious Adverse Events |
||
| eCoin Tibial Nerve Stimulation | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/133 (3%) | |
| Infections and infestations | ||
| Postoperative wound infection | 1/133 (0.8%) | 1 |
| Implant site infection | 2/133 (1.5%) | 2 |
| Skin and subcutaneous tissue disorders | ||
| Contact Dermatitis | 1/133 (0.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| eCoin Tibial Nerve Stimulation | ||
| Affected / at Risk (%) | # Events | |
| Total | 17/133 (12.8%) | |
| Gastrointestinal disorders | ||
| Anal incontinence | 1/133 (0.8%) | 1 |
| General disorders | ||
| Implant site swelling | 1/133 (0.8%) | 1 |
| Medical device site discomfort | 1/133 (0.8%) | 1 |
| Infections and infestations | ||
| Postoperative wound infection | 1/133 (0.8%) | 1 |
| Wound abcess | 1/133 (0.8%) | 1 |
| Injury, poisoning and procedural complications | ||
| Incision site erythema | 1/133 (0.8%) | 1 |
| Incision site pain | 1/133 (0.8%) | 1 |
| Wound | 1/133 (0.8%) | 1 |
| Wound dehiscence | 1/133 (0.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Muscoskeletal discomfort | 1/133 (0.8%) | 1 |
| Pain in extremity | 1/133 (0.8%) | 1 |
| Product Issues | ||
| Device stimulation issue | 6/133 (4.5%) | 6 |
| Device dislocation | 2/133 (1.5%) | 2 |
| Device malfunction | 1/133 (0.8%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Skin irritation | 1/133 (0.8%) | 1 |
Limitations/Caveats
A limitation of the study was the lack of blinding and comparison. Considering that neuromodulation studies are generally not blinded since the therapy itself is sensed, a control group with a similar safety profile to eCoin could not be achieved. We also acknowledge that a 12-month endpoint provides only medium-term data on the durability of response and future longer follow up data will be needed.
More Information
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 | Jackie Dister |
|---|---|
| Organization | Valencia Technologies |
| Phone | 7604294787 |
| jdister@valenciatechnologies.com |
Responsible Party:
Valencia Technologies Corporation
ClinicalTrials.gov Identifier:
NCT03556891
Other Study ID Numbers:
- 111-3281
First Posted:
Jun 14, 2018
Last Update Posted:
Jul 30, 2021
Last Verified:
Jul 1, 2021