S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain

NCT03003845 | Completed

• 1 other identifier: 27338
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

For each patient in the study, blood, and pain scores will be collected to look for markers for pain, at the start of treatment and 6 months after surgery of treatment.

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain Scores on the Visual Analog Scale at 6 months

  S1PR1 levels in PBLs can discriminate patients with Interstitial Cystitis pain and patients with other types of pain.

  3 months

Study Arms (1)

Interstitial Cystitis

Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months

Other: Questionnaires; Other: Collection of Blood samples

Interventions

Questionnaires OTHER

QOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery

Interstitial Cystitis

Collection of Blood samples OTHER

Blood for PBLs will be collected at 3, 6, and 12 months post surgery

Interstitial Cystitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women are included. The onset of interstitial cystitis usually occurs between 30 and 70 years of age, with a median age of 43. .

You may qualify if:

• years of age
• Patients must be able to provide written informed consent.
• Diagnosis of Interstitial Cystitis documented by provider

You may not qualify if:

• age \<18 or \>70 years of age
• pregnant

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University Department of Obstetrics, Gynecology, and Women's Health

St Louis, Missouri, 63117, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

PERIPHERAL BLOOD LEUKOCYTE (PBLS) ANALYSIS (Research Related): Using immunoblotting, we will determine if the level of S1PR1 expression in peripheral blood leukocytes (PBLs) is increased in patients with IC pain. Patients will have blood samples taken, at the visit they sign the consent form 3 and 6 months later. A total of 4 teaspoons of blood will be taken for the study.

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eugen C Campian, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 28, 2016
• Study Start: February 26, 2019
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)