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OpenTrials
Completed

NCT Number: NCT03003845

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

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.

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Key information

Conditions

Interstitial Cystitis Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

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

St Louis, Missouri, 63117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

Collection of blood samples

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study 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

Acronym: S1P1

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 28, 2016
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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