Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

NCT06096597 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY20231301
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

interstitial cystitis; painful bladder syndrome

Outcome Measures

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)

  To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively

Secondary Outcomes (7)

• Change in Interstitial Cystitis Symptom Index Questionnaire

  To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively

• Change in Interstitial Cystitis Problem Index Questionnaire

  To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively

• Change in Bladder Pain/ Interstitial Cystitis Symptom Score

  To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively

• Change in Overactive Bladder Assessment Tool Scores

  To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively

• Change in SF-12 Health Survey Scores

  To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively

Study Arms (2)

Amniotic Membrane Therapy

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

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

Amniotic Membrane Therapy

Placebo DRUG

10 mL of 0.9% preservative-free sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Sheyn: lead

Study Sites (1)

University Hospitals

Clevleand, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• David Sheyn, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margot Le Neveu, MD

CONTACT

‪(440) 895-7685; Margot.LeNeveu@uhhospitals.org

David Sheyn, MD

CONTACT

David.Sheyn@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician, UH Hospitals

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 24, 2023
• Study Start: July 24, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)