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

Not Applicable

Withdrawn

• Conditions: Bladder Pain Syndrome; Interstitial Cystitis
• Interventions: Procedure: 40mg Triamcinolone Injections in the Bladder

• Registration Number: NCT05226832
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-07
• Study Start: 2022-08
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Injection Group	40mg Triamcinolone Injections in the Bladder	-

Primary Outcome Measures

Name	Time	Method
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