Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

Part of paid clinical trials in Clevleand, Ohio.

Sponsor
David Sheyn
Study ID
NCT06096597
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Clarix Flo — DRUG
    100 mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride
  • Placebo — DRUG
    10 mL of 0.9% preservative-free sodium chloride

Study Details

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.

Key Dates

Start date
Jul 24, 2024
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Amniotic Membrane Therapy
    Under general anesthesia, cystoscopy will be performed. A needle will be inserted into the detrusor muscle to a depth of approximately 2 mm. 100mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride, and 0.5 mL of the solution will be injected into 20 equally spaced sites into the posterior and lateral walls of the bladder, sparing the dome and the trigone.
  • Placebo Comparator: Placebo
    Under general anesthesia, cystoscopy will be performed. A needle will be inserted into the detrusor muscle to a depth of approximately 2 mm. 0.5 mL of 10 mL of 0.9% preservative-free sodium chloride will be injected into 20 equally spaced sites into the posterior and lateral walls of the bladder, sparing the dome and the trigone.

Primary Outcome Measure

Change in Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University HospitalsClevleandOhio44106
Diana Mitchell, MD
[email protected]
(216) 844-3009

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By research site
University Hospitals· Clevleand, OH

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