ACTIVE_NOT_RECRUITING

F15 Recharge Free Axonics SNM System Clinical Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.

Official Title

Prospective, Non-randomized, Multicenter Clinical Evaluation of the Recharge Free Axonics SNM System (Model 4101)

Quick Facts

Study Start:2023-12-08
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06186765

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years or older
  2. 2. Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment
  3. 3. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year.
  1. 1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of neurological conditions such as multiple sclerosis)
  2. 2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
  3. 3. Previously underwent an external sacral neuromodulation (SNM) trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
  4. 4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
  5. 5. A female who is breastfeeding
  6. 6. A female with a positive urine pregnancy test

Contacts and Locations

Principal Investigator

Prof. Bertil Blok, MD, PhD
PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Gita Ghadimi, OD
STUDY_DIRECTOR
Boston Scientific Corporation

Study Locations (Sites)

Hartford Healthcare
Waterford, Connecticut, 06385
United States
Florida Gulf Clinical Research
Bradenton, Florida, 34205
United States
East Coast Institute of Research
Jacksonville, Florida, 32216
United States
Florida Bladder Institute
Naples, Florida, 34109
United States
Atrium Health
Macon, Georgia, 31201
United States
Minnesota Urology
Coon Rapids, Minnesota, 55433
United States
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska, 68114
United States
Columbia University Medical Center
New York, New York, 10032
United States
The Oregon Clinic
Portland, Oregon, 97225
United States
Southern Shores Urogynecology
Myrtle Beach, South Carolina, 29572
United States
Houston Colon
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Axonics, Inc.

  • Prof. Bertil Blok, MD, PhD, PRINCIPAL_INVESTIGATOR, Erasmus Medical Center
  • Gita Ghadimi, OD, STUDY_DIRECTOR, Boston Scientific Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-08
Study Completion Date2027-03

Study Record Updates

Study Start Date2023-12-08
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • Urinary Urge Incontinence (UUI)
  • Urinary Frequency (UF)
  • Fecal Incontinence (FI)