Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

Sponsor

David Sheyn (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06096597

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Cystitis Painful Bladder Syndrome Painful Bladder Syndrome (PBS)	Drug: Clarix Flo Drug: Placebo	Phase 3

Detailed 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. These symptoms vary in severity and are known to cause significant impact on quality of life. Current recommended therapies include behavior modifications, stress management practices, physical therapy, oral pharmacologic pain management agents, intravesical instillations, hydrodistension, fulguration of bladder lesions and/or triamcinolone injections, intradetrusor onabotulinumtoxin A injections, neuromodulation, and major surgery.

Amniotic membranes, Clarix FLO™, have been used to assist in wound healing in many fields of medicine, and its use has evolved over the last century to various applications in regenerative medicine. A novel study using amniotic membranes for bladder therapy has showing promising preliminary results in a small cohort study of 10 females with recalcitrant IC/PBS. These women underwent intradetrusor injections of micronized amniotic membranes and had significant improvement of voiding symptoms and bladder pain over 3 months with no adverse events. No randomized controlled trials (RCT) of amniotic bladder therapy have been conducted to date. The proposed study would be the first RCT assessing the efficacy of amniotic membrane injections with Clarix FLO™ and has the potential to make significant impacts in the management and treatment of patients with IC/PBS.

Clarix FLO™ is a sterile, particulate human amniotic membrane and umbilical cord tissue product that is aseptically processed in compliance with current Good Tissue Practices from the same donated human tissue (placenta) after determination of eligibility and placenta/cord suitability. Amniotic Membrane and Umbilical Cord products are currently designated by the FDA as tissue products under PHS Act 361 HCT/P (human cells, tissues and cellular and tissue-based products). Clarix FLO™ does not contain living cells.

Patients will then be followed with clinical evaluation and questionnaires repeated at 2, 4, 8 and 12 weeks post-operatively. Additional urine culture and post void residuals will be repeated at 2 and 4 weeks post-operatively. Primary Objective: Determine the efficacy of amniotic bladder therapy (ABT) in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) as defined by clinically-significant improvement - Clinically-meaningful indicator defined as: 5 point reduction in Interstitial Cystitis Symptom Index (ICSI)

Secondary Objectives:

Characterize duration of effect of ABT using clinical evaluation and the following questionnaires:
Interstitial Cystitis Symptom Index (ICSI)
Interstitial Cystitis Problem Index (ICPI)
Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)
Overactive Bladder Assessment Tool
SF-12 Health Survey
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Determine if there are any adverse effects of ABT, such as urinary tract infections or acute urinary retention. Hypothesis: ABT in patients with PBS improves clinical outcomes

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

At time of surgery, the surgeon will be given a sealed envelope containing a sterile syringe of either 10 mL of 0.9% preservative-free sodium chloride or 100 mg of commercially available micronized AM (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Clarix Flo 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 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.	Drug: Placebo 10 mL of 0.9% preservative-free sodium chloride

Arm

Intervention/Treatment

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.

Drug: Clarix Flo

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 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.

Drug: Placebo

10 mL of 0.9% preservative-free sodium chloride

Outcome Measures

Primary Outcome Measures

Change in Interstitial Cystitis Symptom Index (ICSI) score [To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
Evaluate for clinically-meaningful reduction in symptoms as defined as a 5 point reduction in Interstitial Cystitis Symptom Index (ICSI)

Secondary Outcome Measures

Change in Interstitial Cystitis Symptom Index Questionnaire [To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
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).
Change in Interstitial Cystitis Problem Index Questionnaire [To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
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).
Change in Bladder Pain/ Interstitial Cystitis Symptom Score [To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
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).
Change in Overactive Bladder Assessment Tool Scores [To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
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
Change in SF-12 Health Survey Scores [To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
To determine the change in interstitial cystitis symptoms in participants who received amniotic membrane injection versus placebo injection (saline) as measured using the SF-12 Health Survey
Change in number of urinary tract infections as measured by medical record review [To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively]
As defined by symptoms of urinary tract infection and positive urine culture

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

David Sheyn

Investigators

Principal Investigator: David Sheyn, MD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Sheyn, Physician, UH Hospitals, University Hospitals Cleveland Medical Center

ClinicalTrials.gov Identifier:

NCT06104787

Other Study ID Numbers:

STUDY20231301
NCT06104787

First Posted:

Oct 24, 2023

Last Update Posted:

Oct 24, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by David Sheyn, Physician, UH Hospitals, University Hospitals Cleveland Medical Center

interstitial cystitis

painful bladder syndrome

Additional relevant MeSH terms:

Cystitis

Cystitis, Interstitial

Syndrome

Pain

Study Results

No Results Posted as of Oct 24, 2023