Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDavid Sheyn
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients 18 years of age or older
Female
English Speaking
Diagnosis of IC/PBS
Disqualifiers
Patients less than 18 years of age
Unable to provide consent
Non-English speaking
Patients with known anatomical malformations of the ureters, bladder, or urethra
Trial design
Design model
Single group
Treatments tested in this trial
Clarix Flo
Drug100 mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride
Placebo
Drug10 mL of 0.9% preservative-free sodium chloride
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Amniotic Membrane TherapyExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Interstitial Cystitis Symptom Index (ICSI) score
Evaluate for clinically-meaningful reduction in symptoms as defined as a 5 point reduction in Interstitial Cystitis Symptom Index (ICSI)
Time frame
To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operativelySecondary outcomes
1
Change in Interstitial Cystitis Symptom Index Questionnaire
To determine the change in interstitial cystitis symptoms in participants who received amniotic membrane injection versus placebo injection (saline) as measured using the Interstitial Cystitis Symptom Index (ICSI).
Time frame
To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively2
Change in Interstitial Cystitis Problem Index Questionnaire
To determine the change in interstitial cystitis symptoms in participants who received amniotic membrane injection versus placebo injection (saline) as measured using the Interstitial Cystitis Problem Index (ICPI).
Time frame
To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively3
Change in Bladder Pain/ Interstitial Cystitis Symptom Score
To determine the change in interstitial cystitis symptoms in participants who received amniotic membrane injection versus placebo injection (saline) as measured using the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS).
Time frame
To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively4
Change in Overactive Bladder Assessment Tool Scores
To determine the change in interstitial cystitis symptoms in participants who received amniotic membrane injection versus placebo injection (saline) as measured using the Overactive Bladder Assessment Tool
Time frame
To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operativelyLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
University HospitalsRecruiting44106, Clevleand, Ohio
United States
United StatesSponsors and contacts
Click on the lead sponsor to view all of their trials.
David Sheyn
Lead sponsor
University Hospitals Cleveland Medical Center
Sponsor institution
Source ClinicalTrials.gov