This trial is testing whether a new method of testing for and treating urinary infections is more effective than the current standard.
- Interstitial Cystitis
1 Primary · 4 Secondary · Reporting Duration: 1 year
0 Treatment Group
100 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · N/A
Who is running the clinical trial?
Age 18 - 80 · Female Participants · 8 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Giannantoni, Antonella, Vittorio Bini, Roger Dmochowski, Philip Hanno, J. Curtis Nickel, Silvia Proietti, and Jean Jacques Wyndaele. 2012. “Contemporary Management of the Painful Bladder: A Systematic Review”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2011.07.069.
- Alidjanov, Jakhongir F., Kurt G. Naber, Adrian Pilatz, and Florian M. Wagenlehner. 2020. “Validation of the American English Acute Cystitis Symptom Score”. Antibiotics. MDPI AG. doi:10.3390/antibiotics9120929.
- Nickel, J., Alisa Stephens-Shields, J. Landis, Chris Mullins, Adrie van Bokhoven, M. Lucia, Jeffrey Henderson, et al.. 2019. “A Culture-independent Analysis of the Microbiota of Female Interstitial Cystitis/bladder Pain Syndrome Participants in the MAPP Research Network”. Journal of Clinical Medicine. MDPI AG. doi:10.3390/jcm8030415.
- O'Leary, Michael P., Grannum R. Sant, Floyd J. Fowler Jr, Kristine E. Whitmore, and Judy Spolarich-Kroll. 1997. “The Interstitial Cystitis Symptom Index and Problem Index”. Urology. Elsevier BV. doi:10.1016/s0090-4295(99)80333-1.
- Nickel, J. Curtis, Alisa Stephens, J. Richard Landis, Chris Mullins, Adrie van Bokhoven, M. Scott Lucia, Garth D. Ehrlich, and MAPP Research Network. 2016. “Assessment of the Lower Urinary Tract Microbiota During Symptom Flare in Women with Urologic Chronic Pelvic Pain Syndrome: A MAPP Network Study”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2015.09.075.
- Hanno, Philip M., David Allen Burks, J. Quentin Clemens, Roger R. Dmochowski, Deborah Erickson, Mary Pat FitzGerald, John B. Forrest, et al.. 2011. “AUA Guideline for the Diagnosis and Treatment of Interstitial Cystitis/bladder Pain Syndrome”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2011.03.064.
- Nickel JC, Stephens-Shields AJ, Landis JR, Mullins C, van Bokhoven A, Lucia MS, Henderson JP, Sen B, Krol JE, Ehrlich GD; MAPP Research Network. A Culture-Independent Analysis of the Microbiota of Female Interstitial Cystitis/Bladder Pain Syndrome Participants in the MAPP Research Network. J Clin Med. 2019 Mar 26;8(3):415. doi: 10.3390/jcm8030415.
- Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
- O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.
- Alidjanov JF, Naber KG, Pilatz A, Wagenlehner FM. Validation of the American English Acute Cystitis Symptom Score. Antibiotics (Basel). 2020 Dec 19;9(12):929. doi: 10.3390/antibiotics9120929.
- Giannantoni A, Bini V, Dmochowski R, Hanno P, Nickel JC, Proietti S, Wyndaele JJ. Contemporary management of the painful bladder: a systematic review. Eur Urol. 2012 Jan;61(1):29-53. doi: 10.1016/j.eururo.2011.07.069. Epub 2011 Sep 9.
- 2022. "Assessment of Urinary Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) Technology in the Evaluation and Management of Females With Chronic Bladder Pain and Cystitis-like Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05276466.
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor