Trial Outcomes & Findings for eCoin Tibial Nerve Stimulation for OAB (NCT NCT03029624)

NCT ID: NCT03029624

Last Updated: 2020-12-22

Results Overview

The change in number of incontinence episodes from baseline to three months post-activation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: Baseline to three months post-activation.
• Results posted on: 2020-12-22

Participant Flow

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.

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).

Participant milestones

Measure	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.
Overall Study STARTED	46
Overall Study Primary Endpoint (3 Months)	44
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1
Overall Study Lack of Efficacy	1
Overall Study MRI need	2

Baseline Characteristics

eCoin Tibial Nerve Stimulation for OAB

Baseline characteristics by cohort

Measure	eCoin n=46 Participants 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.
Age, Continuous	63.39 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment New Zealand	20 participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants
Urinary incontinence	5.9 episodes/day STANDARD_DEVIATION 3.1 • n=5 Participants
Urgency urinary incontinence	5.2 episodes/day STANDARD_DEVIATION 2.9 • n=5 Participants
No. OAB medication at screening	9 Participants n=5 Participants
No. OAB medication history	46 Participants n=5 Participants
Incontinence Quality of Life (I QoL) score	45.39 score on a scale STANDARD_DEVIATION 20.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to three months post-activation.

Population: Intent-to-treat

The change in number of incontinence episodes from baseline to three months post-activation.

Outcome measures

Measure	eCoin n=46 Participants 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.
Incontinent Episodes	-3.0 episodes/day Standard Deviation 2.9

SECONDARY outcome

Timeframe: Implantation to one month post-implantation.

Population: Intent-to-treat

Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.

Outcome measures

Measure	eCoin n=46 Participants 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.
System and Procedure Related AEs	20 Adverse Events

SECONDARY outcome

Timeframe: Baseline to 3 months post-activation.

Population: Intent-to-treat

Number of all Major Adverse Events from baseline to 3 months post-activation.

Outcome measures

Measure	eCoin n=46 Participants 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.
MAEs	3 Adverse Events

SECONDARY outcome

Timeframe: 3 months after activation

Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment

Outcome measures

Measure	eCoin n=46 Participants 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.
Percentage of Responders	32 Participants

Adverse Events

eCoin

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	eCoin n=46 participants at risk 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.
Infections and infestations Cellulitis Secondary to Ankle Wrap	2.2% 1/46 • Number of events 1 • Adverse event data was collected from enrollment through 6 months after implantation. The safety population consisted of all eligible and enrolled participants. AEs were graded at the study centers as mild, moderate, or sever; serious or not serious; classified as related or unrelated; and classified as causing or not causing study termination. The Data Safety and Monitoring Board reviewed all AEs to confirm relatedness.
Musculoskeletal and connective tissue disorders Hip Bursitis & Edema	2.2% 1/46 • Number of events 1 • Adverse event data was collected from enrollment through 6 months after implantation. The safety population consisted of all eligible and enrolled participants. AEs were graded at the study centers as mild, moderate, or sever; serious or not serious; classified as related or unrelated; and classified as causing or not causing study termination. The Data Safety and Monitoring Board reviewed all AEs to confirm relatedness.
Infections and infestations Pneumonia	2.2% 1/46 • Number of events 1 • Adverse event data was collected from enrollment through 6 months after implantation. The safety population consisted of all eligible and enrolled participants. AEs were graded at the study centers as mild, moderate, or sever; serious or not serious; classified as related or unrelated; and classified as causing or not causing study termination. The Data Safety and Monitoring Board reviewed all AEs to confirm relatedness.

Other adverse events

Measure	eCoin n=46 participants at risk 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.
General disorders Mild swelling, bruising, discomfort	6.5% 3/46 • Number of events 4 • Adverse event data was collected from enrollment through 6 months after implantation. The safety population consisted of all eligible and enrolled participants. AEs were graded at the study centers as mild, moderate, or sever; serious or not serious; classified as related or unrelated; and classified as causing or not causing study termination. The Data Safety and Monitoring Board reviewed all AEs to confirm relatedness.
Infections and infestations Possible incision site infection	4.3% 2/46 • Number of events 2 • Adverse event data was collected from enrollment through 6 months after implantation. The safety population consisted of all eligible and enrolled participants. AEs were graded at the study centers as mild, moderate, or sever; serious or not serious; classified as related or unrelated; and classified as causing or not causing study termination. The Data Safety and Monitoring Board reviewed all AEs to confirm relatedness.
Skin and subcutaneous tissue disorders Blister secondary to ankle wrap	8.7% 4/46 • Number of events 4 • Adverse event data was collected from enrollment through 6 months after implantation. The safety population consisted of all eligible and enrolled participants. AEs were graded at the study centers as mild, moderate, or sever; serious or not serious; classified as related or unrelated; and classified as causing or not causing study termination. The Data Safety and Monitoring Board reviewed all AEs to confirm relatedness.
General disorders Moderate implant site discomfort, swelling, pain, bruising	10.9% 5/46 • Number of events 5 • Adverse event data was collected from enrollment through 6 months after implantation. The safety population consisted of all eligible and enrolled participants. AEs were graded at the study centers as mild, moderate, or sever; serious or not serious; classified as related or unrelated; and classified as causing or not causing study termination. The Data Safety and Monitoring Board reviewed all AEs to confirm relatedness.
Product Issues Stimulation pain	2.2% 1/46 • Number of events 1 • Adverse event data was collected from enrollment through 6 months after implantation. The safety population consisted of all eligible and enrolled participants. AEs were graded at the study centers as mild, moderate, or sever; serious or not serious; classified as related or unrelated; and classified as causing or not causing study termination. The Data Safety and Monitoring Board reviewed all AEs to confirm relatedness.
Product Issues Device migration about 1 cm posterior	2.2% 1/46 • Number of events 1 • Adverse event data was collected from enrollment through 6 months after implantation. The safety population consisted of all eligible and enrolled participants. AEs were graded at the study centers as mild, moderate, or sever; serious or not serious; classified as related or unrelated; and classified as causing or not causing study termination. The Data Safety and Monitoring Board reviewed all AEs to confirm relatedness.

Additional Information

Stacy Chambliss, Chief of Clinical Trials

Valencia Technologies

Phone: 661-775-1414

Email: schambliss@valenciatechnologies.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place