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NCT03003845 Clinical Trial

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

Interstitial Cystitis Clinical Trial

— S1P1  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03003845
Other study ID # 27338
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 26, 2019
Est. completion date February 27, 2020

Study information
Verified date July 2021
Source St. Louis University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date February 27, 2020
Est. primary completion date February 27, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaires
QOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery
• Collection of Blood samples
Blood for PBLs will be collected at 3, 6, and 12 months post surgery

Locations
Country Name City State
United States Saint Louis University Department of Obstetrics, Gynecology, and Women's Health Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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