Clinical Trial Comparing Two Bladder Instillations for IC/BPS
Condition: Interstitial Cystitis; Bladder Pain Syndrome
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome
Intervention: Bladder instillation WITH triamcinolone acetonide; Bladder instillation WITHOUT triamcinolone acetonide
Intervention description: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).; Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 90.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interstitial cystitis; Bladder pain syndrome; IC/BPS; Women; Pelvic pain; Urologic pain; Bladder instillation; Kenalog; Steroid

Summary:

      Interstitial cystitis/bladder pain syndrome (IC/BPS) is a condition that results in long-term
      bladder and pelvic pain. IC/BPS affects women more often than men. How the disorder develops
      is not completely known. Bladder instillation is a commonly used treatment in which a mixture
      of different ingredients are passed into the bladder to help IC/BPS symptoms. There is room
      to learn more about bladder instillations and which ingredients in them work best. The
      purpose of this study is to compare the effectiveness of a bladder instillation that contains
      a steroid (triamcinolone acetonide) to a bladder instillation that does not contain a steroid
      to treat IC/BPS in women. The study hypothesis is that women with IC/BPS treated with bladder
      instillations that contain a steroid will have improved outcomes compared to women treated
      with bladder instillations that do not contain a steroid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18 years and older

          -  Women with IC/BPS who have a score of ≥ 6 on either index (problem or symptom index)
             of the O'Leary-Sant questionnaire who have selected bladder instillations as part of
             their IC/BPS treatment

          -  Suitability for follow-up

        Exclusion Criteria:

          -  Contraindications and/or allergies to the ingredients used in the bladder
             instillations

          -  Diagnosis of idiopathic thrombocytopenic purpura

          -  Does not desire to undergo bladder instillation therapy or unwilling to undergo
             bladder instillation therapy on schedule mandated by study

          -  Have a known alternative diagnosis explaining bladder pain symptoms that would
             preclude the diagnosis of IC/BPS (e.g. radiation cystitis, active urinary tract
             infection with bacteria or fungus treated within last 2 weeks or diagnosed at index
             visit, bladder injury or trauma within the last 30 days)

          -  Inability to speak or read English

          -  Bladder instillation within the past 4 weeks