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

Completed

• Conditions: Interstitial Cystitis
• Interventions: Other: Questionnaires; Other: Collection of Blood samples

• Registration Number: NCT03003845
• Lead Sponsor: St. Louis University

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.

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 Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Study Start: 2019-02-26
• Primary Completion: 2020-02-27
• Study Completion: 2020-02-27
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interstitial Cystitis	Collection of Blood samples	Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months
Interstitial Cystitis	Questionnaires	Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months

Primary Outcome Measures

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

Trial Locations

Locations (1)

Saint Louis University Department of Obstetrics, Gynecology, and Women's Health; 🇺🇸 Saint Louis, Missouri, United States