A Population-Based Analysis of the Prevalence and Risk Factors for Pentosan Polysulfate Maculopathy

Overview

About this study

The purpose of this study is to to address the current lack of a true prevalent diagnosis of interstitial cystitis and perform outreach to prospectively screen patients with multimodal retinal imaging including fundus examination, fundus autofluorescence, spectral domain optical coherence tomography, and near infrared reflectance imaging by utilizing the Rochester Epidemiology Project (REP).  Additionally, this study aims to provide additional insights into the risk of PPS maculopathy, investigate additional risk factors for PPS maculopathy development, and inform development of evidence-based screening guidelines.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients with a diagnosis of interstitial cystitis.
  • One group of patients with interstitial cystitis who report a history or current use of pentosan polysulfate sodium.
  • An age-matched control group of patients with interstitial cystitis who deny a history or current use of pentosan polysulfate sodium.

Exclusion Criteria:

  • Patients without a diagnosis of interstitial cystitis.

Eligibility last updated 11/9/21. Questions regarding updates should be directed to the study team contact.

 

Residents of the 9-county area surrounding Rochester, MN with a diagnosis of interstitial cystitis identified via the Rochester Epidemiology Project (REP). All patients with a diagnosis of interstitial cystitis will be called via telephone to determine if they have ever taken or are currently taking PPS. Patients who have a history of PPS use or current PPS use will be recruited for a dilated funduscopic examination along with ultra-widefield fundus photography (Optos California icg, Dunfermline, Scotland, UK), ultra-widefield fundus autofluorescence (Optos California icg), spectral-domain macula optical coherence tomography (OCT) (Spectralis, Heidelberg Engineering), and near infrared reflectance (NIR) (Spectralis, Heidelberg Engineering) to screen for evidence of pentosan polysulfate maculopathy. Patients with a diagnosis of interstitial cystitis who denied a history of PPS use will also be recruited to an age-matched control cohort and undergo a dilated funduscopic examination along with ultra-widefield fundus autofluorescence, spectral-domain macula OCT, and NIR to screen for pattern dystrophy-like changes.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Starr, M.D.

Open for enrollment

Contact information:

Blake Fortes M.D.

Fortes.Blake@mayo.edu

More information

Publications

Publications are currently not available