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Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

NCT06096597

RecruitingPhase 2, Phase 3

Sponsor: David Sheyn

Conditions: Interstitial Cystitis, Painful Bladder Syndrome, Painful Bladder Syndrome (PBS)

Interventions: Clarix Flo, Placebo

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Patients 18 years of age or older
* Female
* English Speaking
* Diagnosis of IC/PBS
* Have failed at least one prior treatment for IC/PBS

Exclusion Criteria:

* 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
Locations (1)
  • Clevleand, Ohio, United States