Clinical Trial Comparing Two Bladder Instillations for IC/BPS

NCT03463915 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 18.0209
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Keywords

Interstitial cystitis; Bladder pain syndrome; IC/BPS; Women; Pelvic pain; Urologic pain; Bladder instillation; Kenalog; Steroid

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire

  Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms)

  Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Secondary Outcomes (6)

• Pelvic Pain and Urgency/Frequency (PUF) Questionnaire

  Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

• Overactive Bladder Questionnaire (OAB-q)

  Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

• Pelvic Floor Distress Inventory (PFDI)

  Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

• Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire

  Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

• Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain

  Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Study Arms (2)

Bladder instillation WITH triamcinolone acetonide

ACTIVE COMPARATOR

Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= 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) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).

Drug: Bladder instillation WITH triamcinolone acetonide

Bladder instillation WITHOUT triamcinolone acetonide

PLACEBO COMPARATOR

Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= 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).

Drug: Bladder instillation WITHOUT triamcinolone acetonide

Interventions

Bladder instillation WITH triamcinolone acetonide DRUG

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 WITH triamcinolone acetonide

Bladder instillation WITHOUT triamcinolone acetonide DRUG

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).

Bladder instillation WITHOUT triamcinolone acetonide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olivia Cardenas-Trowers, M.D.: lead

Study Sites (1)

University of Louisville Urogynecology at Springs Medical Center

Louisville, Kentucky, 40205, United States

Location

Related Publications (15)

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  PMID: 15592041 BACKGROUND

• Nickel JC. Interstitial cystitis: a chronic pelvic pain syndrome. Med Clin North Am. 2004 Mar;88(2):467-81, xii. doi: 10.1016/S0025-7125(03)00151-2.

  PMID: 15049588 BACKGROUND

• Aaron LA, Buchwald D. A review of the evidence for overlap among unexplained clinical conditions. Ann Intern Med. 2001 May 1;134(9 Pt 2):868-81. doi: 10.7326/0003-4819-134-9_part_2-200105011-00011.

  PMID: 11346323 BACKGROUND

• Alagiri M, Chottiner S, Ratner V, Slade D, Hanno PM. Interstitial cystitis: unexplained associations with other chronic disease and pain syndromes. Urology. 1997 May;49(5A Suppl):52-7. doi: 10.1016/s0090-4295(99)80332-x.

  PMID: 9146002 BACKGROUND

• Bullones Rodriguez MA, Afari N, Buchwald DS; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Urological Chronic Pelvic Pain. Evidence for overlap between urological and nonurological unexplained clinical conditions. J Urol. 2013 Jan;189(1 Suppl):S66-74. doi: 10.1016/j.juro.2012.11.019.

  PMID: 23234637 BACKGROUND

• Clauw DJ, Schmidt M, Radulovic D, Singer A, Katz P, Bresette J. The relationship between fibromyalgia and interstitial cystitis. J Psychiatr Res. 1997 Jan-Feb;31(1):125-31. doi: 10.1016/s0022-3956(96)00051-9.

  PMID: 9201654 BACKGROUND

• Dawson TE, Jamison J. Intravesical treatments for painful bladder syndrome/ interstitial cystitis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006113. doi: 10.1002/14651858.CD006113.pub2.

  PMID: 17943887 BACKGROUND

• Pazin C, de Souza Mitidieri AM, Silva AP, Gurian MB, Poli-Neto OB, Rosa-E-Silva JC. Treatment of bladder pain syndrome and interstitial cystitis: a systematic review. Int Urogynecol J. 2016 May;27(5):697-708. doi: 10.1007/s00192-015-2815-5. Epub 2015 Aug 14.

  PMID: 26272202 BACKGROUND

• Chaparro LE, Wiffen PJ, Moore RA, Gilron I. Combination pharmacotherapy for the treatment of neuropathic pain in adults. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008943. doi: 10.1002/14651858.CD008943.pub2.

  PMID: 22786518 BACKGROUND

• Cvach K, Rosamilia A. Review of intravesical therapies for bladder pain syndrome/interstitial cystitis. Transl Androl Urol. 2015 Dec;4(6):629-37. doi: 10.3978/j.issn.2223-4683.2015.10.07.

  PMID: 26816864 BACKGROUND

• Barua JM, Arance I, Angulo JC, Riedl CR. A systematic review and meta-analysis on the efficacy of intravesical therapy for bladder pain syndrome/interstitial cystitis. Int Urogynecol J. 2016 Aug;27(8):1137-47. doi: 10.1007/s00192-015-2890-7. Epub 2015 Nov 20.

  PMID: 26590137 BACKGROUND

• Soucy F, Gregoire M. Efficacy of prednisone for severe refractory ulcerative interstitial cystitis. J Urol. 2005 Mar;173(3):841-3; discussion 843. doi: 10.1097/01.ju.0000153612.14639.19.

  PMID: 15711286 BACKGROUND

• Cox M, Klutke JJ, Klutke CG. Assessment of patient outcomes following submucosal injection of triamcinolone for treatment of Hunner's ulcer subtype interstitial cystitis. Can J Urol. 2009 Apr;16(2):4536-40.

  PMID: 19364425 BACKGROUND

• Cardenas-Trowers OO, Abraham AG, Dotson TK, Houlette BA, Gaskins JT, Francis SL. Bladder Instillations With Triamcinolone Acetonide for Interstitial Cystitis-Bladder Pain Syndrome: A Randomized Controlled Trial. Obstet Gynecol. 2021 May 1;137(5):810-819. doi: 10.1097/AOG.0000000000004348.

  PMID: 33831942 DERIVED

• Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

  PMID: 32734597 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial; Pelvic Pain

Interventions

Administration, Intravesical; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Sean Francis
• Organization: University of Louisville

Sean.francis@louisville.edu

502-561-7260

Study Officials

• Olivia Cardenas-Trowers, M.D.

  University of Louisville

  PRINCIPAL INVESTIGATOR

• Sean Francis, M.D.

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 13, 2018
• Study Start: January 25, 2019
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: September 1, 2021
• Results First Posted: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 1 month and ending 24 months following article publication.
• Access Criteria: Available to investigators whose proposed use of the data is for individual participant data meta-analysis and has been approved by an independent review committee for this purpose. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)