Clinical trial NCT06096597: Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Official title: Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Interstitial Cystitis
Painful Bladder Syndrome
Painful Bladder Syndrome (PBS)
Keywords: interstitial cystitis
painful bladder syndrome
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* PUF
* SF-12 Health Survey
* 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

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

Primary outcomes:
measure: Change in Interstitial Cystitis Symptom Index (ICSI) score
timeFrame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Secondary outcomes:
measure: Change in Interstitial Cystitis Symptom Index Questionnaire
timeFrame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
measure: Change in Interstitial Cystitis Problem Index Questionnaire
timeFrame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
measure: Change in Bladder Pain/ Interstitial Cystitis Symptom Score
timeFrame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
measure: Change in Overactive Bladder Assessment Tool Scores
timeFrame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
measure: Change in SF-12 Health Survey Scores
timeFrame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
measure: Change in Pelvic Pain and Urgency/ Frequency (PUF) Patient Symptom Scale (PUF) Scores
timeFrame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
measure: Change in number of urinary tract infections as measured by medical record review
timeFrame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: David Sheyn, MD
role: PRINCIPAL_INVESTIGATOR
References: