Axonics SacRal NeuromodulaTIon System RegisTRY Study

NCT05064384 | Completed Results

• 1 other identifier: 105-0076
• Study Type: observational
• Target: 272
• Locations: 2 countries
• Sites: 27

Brief Summary

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

Conditions

Urinary Retention; Urinary Urge Incontinence; Urgency-Frequency; Fecal Incontinence

Keywords

Overactive Bladder, bladder control, bowel control

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  6-months, 1-year

• Performance/Effectiveness - Improvement of Patient 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 UUI diagnosis at baseline were asked about the degree of urgency leaks experienced using the following scale: 0=no urgency; 1=mild urgency; 2= moderate urgency; 3=strong urgency and 4=severe urgency.

  6-months, 1-year

• 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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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).

  1-year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are scheduled to undergo an Axonics Trial or Axonics System will be considered candidates for the study and will be recruited from each Investigator's patient population.

You may qualify if:

• 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
• Willing and capable of providing informed consent
• Capable of participating in all testing associated with this clinical investigation

You may not qualify if:

• For all indications:
• Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
• Any psychiatric or personality disorder at the discretion of the study physician
• History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
• A female who is breastfeeding
• A female with a positive urine pregnancy test
• For OAB \& UR:
• Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
• Current symptomatic urinary tract infection (UTI)
• For FI only:
• Rectomucosal prolapse or congenital anorectal malformation

Sponsors & Collaborators

• Axonics, Inc.: lead

Study Sites (27)

Arkansas Urology Research Center

Little Rock, Arkansas, 72210, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Stanford Medicine

Redwood City, California, 94063, United States

Location

Sansum Clinic Urology

Santa Barbara, California, 93105, United States

Location

Manatee Medical Research Institute

Bradenton, Florida, 34205, United States

Location

Urologic Solutions

Fort Myers, Florida, 33908, United States

Location

Florida Urology Partners

North Redington Beach, Florida, 33708, United States

Location

Pinellas Urology

St. Petersburg, Florida, 33710, United States

Location

Florida Urology Partners

Tampa, Florida, 33606, United States

Location

Northwestern

Chicago, Illinois, 60611, United States

Location

LSU Health

New Orleans, Louisiana, 70112, United States

Location

Ochsner Health

New Orleans, Louisiana, 70121, United States

Location

Chesapeake Urology

Hanover, Maryland, 21076, United States

Location

Comprehensive Urology

Royal Oak, Michigan, 48073, United States

Location

Adult Pediatric Urology & Urogynecology

Omaha, Nebraska, 68114, United States

Location

The Urology Center PC

Omaha, Nebraska, 68114, United States

Location

New Jersey Urology

Englewood, New Jersey, 07631, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0558, United States

Location

Urologic Specialists Oklahoma

Tulsa, Oklahoma, 74146, United States

Location

Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

Penn State University

Hershey, Pennsylvania, 17033, United States

Location

The Female Pelvic Health Center

Newtown, Pennsylvania, 33606, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Southern Urogynecology

West Columbia, South Carolina, 29169, United States

Location

Center for Pelvic Health

Franklin, Tennessee, 37067, United States

Location

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Urinary Retention; Urinary Incontinence, Urge; Fecal Incontinence; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Urinary Bladder Diseases

Results Point of Contact

• Title: Karen Noblett, MD, Chief Medical Officer
• Organization: Boston Scientific

karen.noblett@bsci.com

559-250-8082

Study Officials

• Karen Noblett, MD

  Axonics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: November 30, 2020
• Primary Completion: October 6, 2023
• Study Completion: March 31, 2024
• Last Updated: September 22, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (26)