Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Platelet Activating Factor Stability in Urine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103477
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eugen C. Campian, MD, St. Louis University

Brief Summary:

The investigator's hypothesis is that smoking induces inflammation in the bladder wall. This may predispose to the development of Interstitial cystitis(IC) / bladder pain syndrome(BPS). Previous research has linked one the Platelet Activating Factor - PAF to interstitial cystitis. The investigators will study a limited number of patients to determine whether PAF is stable in urine and whether special precautions (for example - immediate freezing in liquid nitrogen) is necessary for accurate measurement of PAF in the urine.

Patients who are presenting for an office visit will be asked to donate at least 50 ml of urine.

A separate group of patients who are scheduled for surgery, are also being asked to donate around 25 ml of urine during surgery.

No patient data other than group assignment, whether they smoke or if they have or not have interstitial cystitis will be recorded.


Condition or disease Intervention/treatment
Interstitial Cystitis Other: Urine stability

Detailed Description:

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe, chronic bladder condition that is extremely painful and disruptive. Incidence of the disease has increased dramatically in recent years, primarily due to enhanced awareness and better defined inclusion criteria. Difficulty in diagnosis arises from the diversity of symptoms and severity between patients and in the same patient at different times. IC/BPS is generally accepted as a disease of exclusion in which a diagnosis is reached after ruling out other conditions. A firm diagnosis is only mildly assuring for patients because there are very few therapeutic approaches that can alleviate the symptoms. Several risk factors are associated with IC/BPS, including age, sex and race [5] and modifiable risk factors such as diet and smoking. This proposal is to test the hypothesis that cigarette smoking contributes directly to changes in the bladder that are indicative of, or predispose to, IC/BPS. In preliminary studies, the investigators have exposed mice to cigarette smoke and observed breaks in the urothelium, decreased urothelial tight junction protein expression, increased vascularity and inflammatory cells in the bladder wall. This lab has previously demonstrated that cigarette smoke inhibits endothelial cell platelet activating factor acetylhydrolase (PAF-AH), which is responsible for the hydrolysis of PAF, resulting in increased PAF, a membrane phospholipid-derived inflammatory mediator. The investigators have also shown that calcium-independent phospholipase A2β (iPLA2β) is responsible for the majority of PAF production in endothelial and urothelial cells. PAF has been shown to increase matrix metalloproteinases (MMP) which in turn inhibit anti-angiogenic pigment epithelium-derived factor (PEDF), thus promoting angiogenesis. These studies indicate a direct relationship between PAF accumulation and PEDF expression in the bladder that may contribute to inflammation in smokers.

PAF stability in urine has not been established in the literature. This study is proposing to assess PAF and PAF-AH activity in urine after using various handling methods of the urine specimen. Better understanding of PAF stability will allow for better design of future experiments involving PAF in interstitial cystitis patients.

The investigators have exposed mice to cigarette smoke and examined changes in the bladder. they have observed thinning and sloughing of the urothelium, plus increased vascularization. These changes are observed in the bladder wall of IC/BPS patients. We have measured increased PAF accumulation and decreased expression of PEDF in the bladder wall.

Layout table for study information
Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Activating Factor Stability in Urine
Actual Study Start Date : January 27, 2017
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Office

Patients presenting for a routine office visit will be asked to donate at least 50 ml of urine. The urine specimen will be aliquoted in containers, one with and one without a PAF-AH inhibitor and kept at room temperature.

The aliquots (2mL) will be frozen at predetermined intervals of 5, 10, 20, 40 and 60 min from time of collection in liquid nitrogen and then later stored in -80 freezer.

Other: Urine stability
This study is proposing to assess PAF and PAF-AH activity in urine after using various handling methods of the urine specimen. Better understanding of PAF stability will allow for better design of future experiments involving PAF in interstitial cystitis patients.

Surgery
A separate group of patients undergoing surgery lasting more than 60 min operating time, will be consented as well. These patients have Foley catheters in place during the surgery. Five cc's of urine will be collected from the catheter at pre-determined intervals 5, 10, 20, 40 and 60 minutes, aliquoted (2mL) and frozen in liquid nitrogen and later stored in the -80 freezer.
Other: Urine stability
This study is proposing to assess PAF and PAF-AH activity in urine after using various handling methods of the urine specimen. Better understanding of PAF stability will allow for better design of future experiments involving PAF in interstitial cystitis patients.




Primary Outcome Measures :
  1. PAF production [ Time Frame: 1 hour ]
    elicits changes in the bladder wall that can predispose to IC/BPS. In this aim, the investigators will determine whether urine PAF is stable at room temperature, or whether special precautions (e.g. freezing or use of PAF-AH inhibitors) are needed for accurate PAF measurements in urine samples.


Biospecimen Retention:   Samples Without DNA
This study is proposing to assess PAF and PAF-AH activity in urine after using various handling methods of the urine specimen. Better understanding of PAF stability will allow for better design of future experiments involving PAF in interstitial cystitis patients.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Adult females with r without IC
Criteria

Inclusion Criteria:

  • Patient presenting for routine care in the UroGynecology division or
  • Patient undergoing gynecologic or urogynecologic surgery exceeding 60 minute operating time.

Exclusion Criteria:

  • Age less than 18 or more than 80
  • Unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103477


Locations
Layout table for location information
United States, Missouri
St. Mary's Health Center
Saint Louis, Missouri, United States, 63117
Sponsors and Collaborators
St. Louis University
Investigators
Layout table for investigator information
Principal Investigator: Eugen C Campian, MD St. Louis University
Layout table for additonal information
Responsible Party: Eugen C. Campian, MD, Principal investigator, St. Louis University
ClinicalTrials.gov Identifier: NCT03103477    
Other Study ID Numbers: 27756
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases