Phase
Condition
Interstitial Cystitis
Treatment
Axonics System
Clinical Study ID
Ages > 21 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who are ≥ 21 years at the time of consent
Has a primary indication of UUI (participants with a secondary indication of UF orFI may also be enrolled)
Has a diagnosis of UUI for greater than or equal to 6 months prior to the date ofconsent
UUI episodes:
For currently implanted participants (Group A), they must be considered therapyresponders with a >50% reduction in UUI episodes (based on their originalbaseline diaries) and satisfied with their SNM therapy
For de novo candidates (Group B), they must have completed a successful PNEdocumented with a >50% reduction in UUI episodes on a 3-day diary (a diary mustexist within a medical record or equivalent)
Willing and capable of providing informed consent
Agrees to return to the site for all study visits
Fluent (able to speak and read) in English
Exclusion
Exclusion Criteria:
Any participant that the study Investigator deems to be a poor candidate who isunable to complete a 72-hour bladder diary or will be non-compliant for study visits
Diagnosis of urinary retention
Surgical treatment for stress incontinence (e.g. sling, Burch), and/or pelvic organprolapse in the past 3 months or recommended or planned within 3 months from thetime of consent
Changes to current regimen of medications that could impact bladder function within 4 weeks prior to consent
Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement orurethral stricture)
Current symptomatic urinary tract infection (UTI)
A patient who early discontinued from the ARTISTRY registry
A female with a positive urine pregnancy test
A female who is breastfeeding
Study Design
Study Description
Connect with a study center
The Florida Bladder Institute
Naples, Florida 34109
United StatesSite Not Available
LSU Health
New Orleans, Louisiana 70112
United StatesSite Not Available
University Hospitals-Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Urologic Specialists Oklahoma
Tulsa, Oklahoma 74146
United StatesSite Not Available
The Female Pelvic Health Center
Newton, Pennsylvania 18940
United StatesSite Not Available
Center for Pelvic Health
Franklin, Tennessee 37067
United StatesSite Not Available

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