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PCR + DNA Sequencing for Interstitial Cystitis
Study Summary
This trial is testing whether a new method of testing for and treating urinary infections is more effective than the current standard.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have had symptoms for at least 3 months without stopping.You have bladder pain or chronic urinary symptoms.You have bladder pain or urinary symptoms that bother you.You have not taken any supplements for urinary tract infection (UTI) in the past two weeks, such as cranberry, d-mannose, high dose vitamin C, or Lactobacillus probiotics.You have had a bladder instillation in the past 4 weeks.You have had symptoms for at least 3 months without any long breaks.You have had at least moderate bladder pain on most days for the past 3 months, rated at 3 or higher on a 0-10 pain scale.You have certain medical conditions like bladder stones, vaginal candidiasis, or urinary retention that could affect your safety in the study or make it difficult to understand the results.You have had surgery to change the way urine leaves your body or to make your bladder bigger.You have a tube in your ureter.You have had a catheter inserted in the past month.You have taken antibiotics based on MicroGenDX's NGS results in the past 12 months.You have tried standard treatments based on previous urine tests, but they didn't work well for you.If you have pain in your bladder and/or urethra, and experience symptoms like needing to urinate often, you can join the study.You have not taken antibiotics in the past 2 weeks.You have not taken any urinary tract infection supplements like cranberry, d-mannose, high dose vitamin C, and Lactobacillus probiotics in the past 2 weeks.You are currently getting treatment for cancer such as surgery, radiation, or chemotherapy within the last 8 weeks.You have a bladder condition caused by a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida, or diabetes.You have experienced visible blood in your urine within the past year that has not been checked by a doctor.You have had bladder procedures or treatments within the specified time frames before the screening.You have had an active genital herpes outbreak within the past 3 months before the screening.
- Group 1: Single arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are individuals currently being recruited for involvement in this experiment?
"Affirmative. The particulars of the trial, which were initially declared on February 1st 2022 and last updated March 2nd 2022, are available to view on clinicaltrials.gov; these details indicate that 100 subjects will be enrolled at two separate locations."
To what extent is this experiment being conducted with human participants?
"Affirmative, the data on clinicaltrials.gov confirms that this trial is presently enrolling patients. The study's first posting date was February 1st 2022 and it was most recently updated on March 2nd 2022. This medical investigation requires 100 participants from two distinct locations to partake in their experimentations."
Is it possible for me to enroll in this experiment?
"This clinical trial is recruiting 100 individuals suffering from bladder pain syndrome, ranging in age between 18 and 80. Notably, potential participants must abide by the following conditions: Signed informed consent that includes agreement with protocol-specified requirements and limitations; Diagnosis of BPS (NIH/NIDDK/MAPP) or CCS (modified ACSS); Previous unsuccessful antibiotic treatment based on past urine culture results; At least 3 months continuous symptoms; Average daily bladder pain score ≥3 on a 0-10 NRS scale in preceding 3 months; No antibiotics nor UTI supplements for two weeks prior to enrollment."
Does this medical experiment have an age restriction of 80 years or below?
"This clinical trial has established age parameters, with minimum enrollment being 18 years old and the maximum enrolment at 80."
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