RECRUITING

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Interstitial cystitis/painful bladder syndrome (IC/PBS) is a clinical syndrome in which patients report symptoms of bladder and/or pelvic pain with pressure and/ or discomfort associated with urinary frequency and urgency. The primary objective of this study is to determine the efficacy of amniotic membrane therapy in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) as defined by clinically-significant improvement in validated symptom questionnaires.

Official Title

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-Blind, Randomized Controlled Trial

Quick Facts

Study Start:2024-07-24
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06096597

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients 18 years of age or older
  2. * Female
  3. * English Speaking
  4. * Diagnosis of IC/PBS
  5. * Have failed at least one prior treatment for IC/PBS
  1. * Patients less than 18 years of age
  2. * Unable to provide consent
  3. * Non-English speaking
  4. * Patients with known anatomical malformations of the ureters, bladder, or urethra

Contacts and Locations

Study Contact

Margot Le Neveu, MD
CONTACT
‪(440) 895-7685
Margot.LeNeveu@uhhospitals.org
David Sheyn, MD
CONTACT
David.Sheyn@uhhospitals.org

Principal Investigator

David Sheyn, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center

Study Locations (Sites)

University Hospitals
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: David Sheyn

  • David Sheyn, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

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 Registration Dates

Study Start Date2024-07-24
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-07-24
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • interstitial cystitis
  • painful bladder syndrome

Additional Relevant MeSH Terms

  • Interstitial Cystitis
  • Painful Bladder Syndrome
  • Painful Bladder Syndrome (PBS)