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

July 22, 2021 updated by: Eugen C. Campian, MD, St. Louis University

Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain : Identification of Potential Relevant Biomarkers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is investigator-initiated, prospective, study. There will be no change in care.

Patients who have had a diagnosis of IC made by cystoscopy and hydrodistension and still have pain will be recruited for this study.

Patients will have blood samples taken at the visit they sign the consent form and 6 months later.

The study staff will call and remind the patient of their 6 month visit.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Saint Louis University Department of Obstetrics, Gynecology, and Women's Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

.

Description

Inclusion Criteria:

  • 18-70 years of age
  • Patients must be able to provide written informed consent.
  • Diagnosis of Interstitial Cystitis documented by provider

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interstitial Cystitis
Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months
Other: Questionnaires
QOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery
Other: Collection of Blood samples
Blood for PBLs will be collected at 3, 6, and 12 months post surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pain Scores on the Visual Analog Scale at 6 months
Time Frame: 3 months
S1PR1 levels in PBLs can discriminate patients with Interstitial Cystitis pain and patients with other types of pain.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2019

Primary Completion (Actual)

February 27, 2020

Study Completion (Actual)

February 27, 2020

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Interstitial Cystitis

Clinical Trials on Questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe