Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome: Pilot Study

• Sponsor: The University of Texas Medical Branch, Galveston (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05226832
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Cystitis; Bladder Pain Syndrome	Procedure: 40mg Triamcinolone Injections in the Bladder	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome: Pilot Study
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Injection Group

Procedure: 40mg Triamcinolone Injections in the Bladder; 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.

Outcome Measures

Primary Outcome Measures

1. O'Leary-Sant Symptom Index; Problem Index; Pain, Urgency, Frequency Symptom Scale [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Medical Branch	Galveston	Texas	United States	77555

Sponsors and Collaborators

• The University of Texas Medical Branch, Galveston

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT05226832
• Other Study ID Numbers: 21-0227
• First Posted: Feb 7, 2022
• Last Update Posted: Feb 7, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome; Somatoform Disorders; Triamcinolone

Study Results

No Results Posted as of Feb 7, 2022