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

The University of Texas System (UT)

Status: Withdrawn

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Treatments: Procedure: 40mg Triamcinolone Injections in the Bladder

Study type: Interventional

Funder types: Other

Identifiers

NCT05226832

21-0227

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Injection Group

Experimental group

Treatment:

Procedure: 40mg Triamcinolone Injections in the Bladder