Platelet Activating Factor Stability in Urine

NCT03103477 | Completed

• 1 other identifier: 27756
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• PAF production

  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.

  1 hour

Study Arms (2)

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

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

Interventions

Urine stability OTHER

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.

Office; Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult females with r without IC

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

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.

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Eugen C Campian, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: April 6, 2017
• Study Start: January 27, 2017
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)