Interstitial CystitisNCT05226832
Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome
A study testing 40mg Triamcinolone Injections in the Bladder in people with Interstitial Cystitis and Bladder Pain Syndrome, run by The University of Texas Medical Branch, Galveston.
Trial summary
This initial pilot project aims to study the use of FDA-approved 40mg triamcinolone injections in the bladder for the management of interstitial cystitis with or without Hunner's lesions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- 40mg Triamcinolone Injections in the Bladder
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet an appropriate diagnosis of IC from NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)
- Patients must be female
- 18 years or older
- Have an official diagnosis of Interstitial Cystitis/Bladder Pain Syndrome
Who cannot join
- Patients who do not meet NIDDK inclusion criteria for Interstitial Cystitis as described above will not me enrolled in the study
- The presence of urinary tract or sexually transmitted infection (may be included once existing infection is treated and cleared)
- Pregnant women
- Patients who have the inability to consent on their own behalf
- Prisoners
About this study
Official title: Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome: Pilot Study
This initial pilot project aims to study the use of FDA-approved 40mg triamcinolone injections in the bladder for the management of interstitial cystitis with or without Hunner's lesions. Intradetrusor triamcinolone injections are already the standard of care for IC patients with Hunner's lesions, but its role in management of IC without Hunner's lesions has yet to be determined. Triamcinolone is a long-acting corticosteroid that acts by inhibiting the migration of polymorphonuclear leukocytes, which may contribute to attenuation of inflammation in interstitial cystitis. We will recruit 27 females 18 years of age or older that have been diagnosed with IC/BPS. Patients will undergo a one-time cystoscopy along with the triamcinolone injections for IC management as a part of the research study. Validated questionnaires will be provided before the treatment to quantify symptoms at baseline and after treatment at follow-up visits. Follow up visits will occur in clinic every 4 to 6 weeks, which will continue for a maximum of 1 year. Scores at follow-up visits will be compared to baseline.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- 40mg Triamcinolone Injections in the Bladder
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40mg Triamcinolone Injections in the BladderProcedure or surgery
Patients will undergo a standard of care cystoscopy with non-standard of care solumedrol injections in the clinic. Subjects will have lidocaine jelly instilled into their bladder for 5 minutes prior to injection cystoscopy. Injections will be performed using a 17fr flexible cystoscope in the outpatient setting. There will be 10 intravesical Injections of 1cc of 40mg solumedrol diluted to 10cc with injectable normal saline. The needle will penetrate the bladder at a depth of 2-3mm using a Laborie endoscopic single use needle, about the length of a pencil tip. The patient may experience discomfort with cystoscopy and injections. Any procedure complications will be noted based on the Clavien-Dindo Classification Index, discussed in the safety section. This is estimated to take 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Injection Group | Experimental | Not described Receives: Procedure: 40mg Triamcinolone Injections in the Bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
O'Leary-Sant Symptom Index; Problem Index; Pain, Urgency, Frequency Symptom Scale
Follow-up visits will occur every 4-to-6-weeks post-procedure as part of UTMB's standard of care. Patients will be asked to fill out The O'Leary-Sant Symptom Index and Problem Index and the Pain, Urgency, Frequency Symptom Scale to quantify symptoms, which is not experimental. No other procedures will occur for Visits #3 and onward. Follow-up visits will continue for a maximum of 1 year
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study startAug 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: Study never started.
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.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226832
- Sponsor's protocol ID
- 21-0227
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome: Pilot Study
- ClinicalTrials.gov ID
- NCT05226832
- Acronym / sponsor ID
- 21-0227
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 7 Feb 2022 (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.
This initial pilot project aims to study the use of FDA-approved 40mg triamcinolone injections in the bladder for the management of interstitial cystitis with or without Hunner's lesions. Intradetrusor triamcinolone injections are already the standard of care for IC patients with Hunner's lesions, but its role in management of IC without Hunner's lesions has yet to be determined. Triamcinolone is a long-acting corticosteroid that acts by inhibiting the migration of polymorphonuclear leukocytes, which may contribute to attenuation of inflammation in interstitial cystitis. We will recruit 27 females 18 years of age or older that have been diagnosed with IC/BPS. Patients will undergo a one-time cystoscopy along with the triamcinolone injections for IC management as a part of the research study. Validated questionnaires will be provided before the treatment to quantify symptoms at baseline and after treatment at follow-up visits. Follow up visits will occur in clinic every 4 to 6 weeks, which will continue for a maximum of 1 year. Scores at follow-up visits will be compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection Group | Experimental | Procedure: 40mg Triamcinolone Injections in the Bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must meet an appropriate diagnosis of IC from NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)
- Patients must be female
- 18 years or older
- Have an official diagnosis of Interstitial Cystitis/Bladder Pain Syndrome
Key exclusion criteria (5 listed)
- Patients who do not meet NIDDK inclusion criteria for Interstitial Cystitis as described above will not me enrolled in the study
- The presence of urinary tract or sexually transmitted infection (may be included once existing infection is treated and cleared)
- Pregnant women
- Patients who have the inability to consent on their own behalf
- Prisoners
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 |
|---|---|---|
| 40mg Triamcinolone Injections in the BladderPatients will undergo a standard of care cystoscopy with non-standard of care solumedrol injections in the clinic. Subjects will have lidocaine jelly instilled into their bladder for 5 minutes prior to injection cystoscopy. Injections will be performed using a 17fr flexible cystoscope in the outpatient setting. There will be 10 intravesical Injections of 1cc of 40mg solumedrol diluted to 10cc with injectable normal saline. The needle will penetrate the bladder at a depth of 2-3mm using a Laborie endoscopic single use needle, about the length of a pencil tip. The patient may experience discomfort with cystoscopy and injections. Any procedure complications will be noted based on the Clavien-Dindo Classification Index, discussed in the safety section. This is estimated to take 30 minutes. | Procedure or surgery | Injection Group |
Primary outcome
O'Leary-Sant Symptom Index; Problem Index; Pain, Urgency, Frequency Symptom Scale
Time frame: One Year
Follow-up visits will occur every 4-to-6-weeks post-procedure as part of UTMB's standard of care. Patients will be asked to fill out The O'Leary-Sant Symptom Index and Problem Index and the Pain, Urgency, Frequency Symptom Scale to quantify symptoms, which is not experimental. No other procedures will occur for Visits #3 and onward. Follow-up visits will continue for a maximum of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Interstitial Cystitis
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 40mg Triamcinolone Injections in the Bladder in people with Interstitial Cystitis and Bladder Pain Syndrome, run by The University of Texas Medical Branch, Galveston.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
O'Leary-Sant Symptom Index; Problem Index; Pain, Urgency, Frequency Symptom Scale (time frame: One Year). 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 26 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.