Interstitial CystitisPhase 2/3NCT06096597
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
A Phase 2/3 study testing Clarix Flo in people with Interstitial Cystitis and Painful Bladder Syndrome, run by David Sheyn at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Interstitial Cystitis, Painful Bladder Syndrome, Painful Bladder Syndrome (PBS)
- What is being tested?
- Clarix Flo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2024to 1 May 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Female
- English Speaking
- Diagnosis of IC/PBS
- Have failed at least one prior treatment for IC/PBS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David Sheyn, MD contact
United States1 site, 1 recruiting
- Recruiting
University Hospitals
Clevleand, Ohio, 44106
Diana Mitchell, MD, (216) 844-3009, diana.mitchell@uhhospital.org
About this study
Official title: Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-Blind, Randomized Controlled Trial
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.
Read the 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
- Being tested
- Clarix Flo, Placebo
- Keywords
- interstitial cystitis, painful bladder syndrome
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarix FloDrug
100 mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride
PlaceboDrug
10 mL of 0.9% preservative-free sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 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).
Measured: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in Interstitial Cystitis Problem Index Questionnaire
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).
Measured: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in Bladder Pain/ Interstitial Cystitis Symptom Score
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).
Measured: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in Overactive Bladder Assessment Tool Scores
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
Measured: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in SF-12 Health Survey Scores
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
Measured: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in Pelvic Pain and Urgency/ Frequency (PUF) Patient Symptom Scale (PUF) Scores
To determine the change in interstitial cystitis symptoms in participants who received amniotic membrane injection versus placebo injection (saline) as measured using the PUF Questionnaire
Measured: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in number of urinary tract infections as measured by medical record review
As defined by symptoms of urinary tract infection and positive urine culture
Measured: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start24 Jul 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Sheyn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Sheyn, University Hospitals Cleveland Medical Center
- Investigators
- David Sheyn, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096597
- Sponsor's protocol ID
- STUDY20231301
- Status last verified
- Sep 2026
- First submitted
- 17 Oct 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06096597
- Acronym / sponsor ID
- STUDY20231301
- Keywords
- interstitial cystitis, painful bladder syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- David SheynUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic Membrane Therapy | Experimental | Drug: Clarix FloUnder 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 | Placebo comparator | Drug: PlaceboUnder 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18 years of age or older
- Female
- English Speaking
- Diagnosis of IC/PBS
- Have failed at least one prior treatment for IC/PBS
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clarix Flo100 mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride | Drug | Amniotic Membrane Therapy |
| Placebo10 mL of 0.9% preservative-free sodium chloride | Drug | Placebo |
Primary outcome
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
Evaluate for clinically-meaningful reduction in symptoms as defined as a 5 point reduction in Interstitial Cystitis Symptom Index (ICSI)
7 secondary outcomes
Change in Interstitial Cystitis Symptom Index Questionnaire
Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in Interstitial Cystitis Problem Index Questionnaire
Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in Bladder Pain/ Interstitial Cystitis Symptom Score
Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in Overactive Bladder Assessment Tool Scores
Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in SF-12 Health Survey Scores
Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in Pelvic Pain and Urgency/ Frequency (PUF) Patient Symptom Scale (PUF) Scores
Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Change in number of urinary tract infections as measured by medical record review
Time frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Sheyn, MD contact
David Sheyn, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clarix Flo in people with Interstitial Cystitis and Painful Bladder Syndrome, run by David Sheyn at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Mitchell, MD ((216) 844-3009, diana.mitchell@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.