Axonics SacRal NeuromodulaTIon System RegisTRY Study

Axonics, Inc.272 enrolled

Overview

To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).

The study will be a prospective, multi-center, single-arm, post-market registry study. Participant outcomes will be compared to their baseline, with participants serving as their own control. The study is expected to complete enrollment in approximately 24 months and follow the patients per protocol for 1 year. The study was conducted at approximately 30 centers in the United States and Canada.

Study Type

OBSERVATIONAL

Enrollment

272

Conditions

Urinary Retention Urinary Urge Incontinence Urgency-Frequency Fecal Incontinence

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients scheduled to be trialed with the Axonics External Trial System (ETS), or patients scheduled to receive an Axonics Implantable neurostimulator (INS) or Axonics FS implant 2. Willing and capable of providing informed consent 3. Capable of participating in all testing associated with this clinical investigation Exclusion Criteria: For all indications: 1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints 2. Any psychiatric or personality disorder at the discretion of the study physician 3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 4. A female who is breastfeeding 5. A female with a positive urine pregnancy test For OAB \& UR: 6. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) 7. Current symptomatic urinary tract infection (UTI) For FI only: 8. Rectomucosal prolapse or congenital anorectal malformation

Locations (27)

Outcomes

Primary Outcomes

Therapy Responder Rate

Percentage of participants who were determined as responders by the treating physician when using the External Trial Stimulator and who received the Axonics System. At least a 50% reduction in symptoms is considered standard in relevant literature for response rate therefore decision for determination of responder was left to PI discretion.

Time frame: External Trial System Evaluation

Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline

Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the number of urgency leaks experienced.

Time frame: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline

Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the number of urinations they experienced per day and at night.

Time frame: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline

Time frame: 6-months, 1-year

Data from ClinicalTrials.gov

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Arkansas Urology Research Center

Little Rock, Arkansas, United States

University of California, Irvine

Irvine, California, United States

Stanford Medicine

Redwood City, California, United States

Sansum Clinic Urology

Santa Barbara, California, United States

Manatee Medical Research Institute

Bradenton, Florida, United States

Urologic Solutions

Fort Myers, Florida, United States

Florida Urology Partners

North Redington Beach, Florida, United States

Pinellas Urology

St. Petersburg, Florida, United States

Florida Urology Partners

Tampa, Florida, United States

Northwestern

Chicago, Illinois, United States

...and 17 more locations

Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline

Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the degree of urgency experienced using the following scale: 0=no urgency; 1=mild urgency; 2= moderate urgency; 3=strong urgency and 4=severe urgency.

Time frame: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline

Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the number of FI episodes experienced.

Time frame: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline

Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the degree of urgency experienced.

Time frame: 6-months, 1-year

Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort

Change in ICIQ-OABqol scores at follow-up compared to baseline for implanted participants. Questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is considered a minimally important difference (MID).

Time frame: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline

Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UR diagnosis at baseline were asked about the number of catheterizations required per day.

Time frame: 6-months, 1-year

Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline

Change in CCF-FIS score at follow-up compared to baseline. Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score indicates more severe FI symptoms and a score ≥ 6 indicates moderate to severe FI symptoms.

Time frame: 6-months, 1-year

Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort

Change in FIQL score compared to baseline for implanted participants. Fecal Incontinence Quality of Life (FIQL) includes four different subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5, with 1 indicating lower functional status of qualify of life.

Time frame: 6-months, 1-year

Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort

Change in O'Leary Sant score at follow-up compared to baseline for all implanted participants. The O'Leary Sant is a validated questionnaire designed to provide data on painful bladder and urinary frequency symptoms. Symptom and Problem Index scores are calculated based on responses to two sets of 4 questions with higher scores representing more symptoms/problems. A total score from 0 - 40 is also calculated based on all responses. At follow-up, an O'Leary Sant was only collected for those participants an O'Leary Sant score ≥ 6 at baseline.

Time frame: 6-months, 1-year

Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort

Change in AUA-SI score at follow-up compared to baseline for Urinary Retention participants who were implanted with the device. The AUA-SI (American Urological Association Symptom Index) is a questionnaire used to assess the severity of lower urinary tract symptoms (LUTS) in men, with scores ranging from 0 to 35, categorizing symptoms as mild (0-7), moderate (8-19), or severe (20-35). A higher score indicates more severe UR symptoms and a score of greater than 8 indicates moderate to severe UR symptoms.

Time frame: 6-months, 1-year

Adverse Event Reporting (Safety)

The number and participant rates of device-related AEs and Serious Adverse Events (SAEs), including Serious Adverse Device Effects (SADEs).

Time frame: 1-year