Phase
Condition
Interstitial Cystitis
Urinary Incontinence
Urinary Tract Infections
Treatment
N/AClinical Study ID
Ages 18-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subjects may be included in the study if they have bladder and/orurethral pain and lower urinary tract storage symptoms and only if they meet all of thefollowing criteria at screening/baseline.
- Subjects are capable of giving signed informed consent, which includes compliance withthe requirements and restrictions listed in this protocol.
- Symptomatic subjects with BPS (NIH/NIDDK/MAPP definition) with perceived bladder pain +/- urinary storage symptoms) or symptomatic patients with CCS (chronic UTI definitionbased on modified ACSS with dysuria)
- Subjects with previous failure of standard urine culture directed therapy approach,eg. antibiotic treatment based on previous urine culture results (positive, sterile,or nebulous) failed to provide appreciable clinical benefit.
- Subjects who have experienced a minimum of 3 months of continuous symptoms
- Subjects who have a minimum average daily bladder pain score of ≥ 3 on a 0-10 NRSscale in the past 3 months
- Subjects with no antibiotic therapy for the previous 2 weeks
- Subjects with no UTI supplements including cranberry, d-mannose, high dose vitamin Cand Lactobacillus probiotics for the previous 2 weeks.
Exclusion
Exclusion Criteria: Subjects will be excluded from participating in this study if they meetany of the following criteria:
- Subjects with any of the following confounding conditions: bladder stones, lowerureteric stones, vaginal candidiasis, urethral diverticulum, urinary retention (≥ 300mL), overactive bladder (ie, urinary urgency secondary to urinary incontinence), orany other condition/disease, which, in the opinion of the investigator, couldcompromise patient safety or confound the collection or interpretation of studyresults.
- Subjects who are pregnant or planning a pregnancy during the study period
- Subjects with a history of previous urinary diversion procedure with or withoutbladder removal or bladder augmentation.
- Subjects with a history of bladder cystoscopy only within 1 month or cystoscopy withbladder biopsy, hydrodistension, fulguration or triamcinolone injection or treatmentof Hunner ulcer performed within 3 months prior to Screening.
- Subjects undergoing active treatment for cancer - urologic (eg bladder) or other -with surgery, radiation or chemotherapy within previous 8 weeks of screening.
- Subjects with a neurogenic bladder (due to spinal cord injury, stroke, Parkinson'sdisease, multiple sclerosis, spina bifida, or diabetic cystopathy).
- Subjects with genital herpes active within 3 months prior to screening.
- Subjects with a history of gross (visible) hematuria within 1 year prior to screeningthat has not been evaluated.
- Subjects who have had major surgery within the past 3 months or has surgery plannedduring the study period
- Subjects with a history of alcohol and/or drug abuse that in the investigator'sopinion could interfere with the study evaluations or the patient's safety.
- Subjects catheterized in the past month
- Subjects that have received antibiotic treatment based on MicroGenDX's NGS results inthe prior 12 months
- Subjects with indwelling ureteral stents
- Subjects that have received a bladder instillation within the last 4 weeks
Study Design
Study Description
Connect with a study center
UCLA Center for Women's Pelvic Health
Los Angeles, California 90095
United StatesActive - Recruiting
The University of California San Diego Health
San Diego, California 92103
United StatesActive - Recruiting
Cooper University Health Care
Camden, New Jersey 08103
United StatesActive - Recruiting
Wake Forest University Baptist Medical Center Urology
Winston-Salem, North Carolina 27103
United StatesCompleted
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