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

Primary Purpose

Interstitial Cystitis, Bladder Pain Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
40mg Triamcinolone Injections in the Bladder
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Injection Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 26, 2022
    Last Updated
    January 23, 2023
    Sponsor
    The University of Texas Medical Branch, Galveston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05226832
    Brief Title
    Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome
    Official Title
    Intradetrusor Triamcinolone Injection in the Management of Interstitial Cystitis/Bladder Pain Syndrome: Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study never started.
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Medical Branch, Galveston

    4. Oversight

    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

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Interstitial Cystitis, Bladder Pain Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Injection Group
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    40mg Triamcinolone Injections in the Bladder
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    O'Leary-Sant Symptom Index; Problem Index; Pain, Urgency, Frequency Symptom Scale
    Description
    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
    Time Frame
    One Year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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