Amniotic Membrane Therapy for Interstitial Cystitis

Phase 2 & 3

Recruiting

Led By David Sheyn, MD

Research Sponsored by David Sheyn

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

Diagnosis of IC/PBS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively

Summary

This trial aims to see if using amniotic membrane therapy can help improve symptoms in patients with interstitial cystitis/painful bladder syndrome (IC/PBS), which causes bladder and/or pelvic pain

Who is the study for?

This trial is for English-speaking women aged 18 or older who have been diagnosed with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) and haven't found relief from at least one previous treatment.

What is being tested?

The study aims to test the effectiveness of amniotic membrane therapy (Clarix Flo) compared to a placebo in improving symptoms of IC/PBS, as measured by responses to symptom questionnaires.

What are the potential side effects?

While specific side effects are not detailed here, potential risks may include discomfort or reactions at the site of therapy application. Side effects related to Clarix Flo will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I have been diagnosed with interstitial cystitis or painful bladder syndrome.

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I have tried at least one treatment for bladder pain syndrome that didn't work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Interstitial Cystitis Symptom Index (ICSI) score

Secondary study objectives

Change in Bladder Pain/ Interstitial Cystitis Symptom Score

Change in Interstitial Cystitis Problem Index Questionnaire

Change in Interstitial Cystitis Symptom Index Questionnaire

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Amniotic Membrane TherapyExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

0 / 3Eligibility criteria met