NCT05226832

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Interstitial Cystitis
• Bladder Pain Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2022-02-07
• Last updated: 2023-01-26