Clinical Trial Comparing Two Bladder Instillations for IC/BPS

Interstitial Cystitis Clinical Trial

Official title:

Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463915
• Other study ID #: 18.0209
• Status: Completed
• Phase: Phase 3
• Start date: January 25, 2019
• Est. completion date: October 23, 2020

Study information

• Verified date: August 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain disorder involving the genitourinary tract. IC/BPS disproportionately affects women with over 80% of patients with IC/BPS as female. Like other chronic pain conditions, IC/BPS is physically and emotionally taxing on patients. IC/BPS costs the United States over $100 million annually due to direct healthcare costs and loss of worker productivity. The exact pathophysiology of the disease is unknown, leading to a limitation in our ability to treat the disorder effectively. The current leading etiologic theory is that IC/BPS is a neurologically-derived chronic systemic pain syndrome due to its association with musculoskeletal pelvic pain, irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, and vulvodynia. Although several options exist to treat IC/BPS, therapeutic effects are often transient. Previous studies in chronic pain disorders have shown that multimodal treatment is more effective than single-agent treatment, so future therapy should aim to augment rather than replace current treatments. Bladder instillation is a commonly used treatment in which a mixture of different agents is instilled into the bladder to improve IC/BPS symptoms. The data on the efficacy of bladder instillations, as well as which ingredients in the mixture are effective, are limited. Small studies have shown the potential of steroids in decreasing IC/BPS; the mechanism of action is hypothesized to be due to decrease inflammation in the bladders of these patients. The knowledge gap that exists is the necessity of a steroid in the bladder instillation treatment for IC/BPS symptoms especially since this tends to be the most expensive ingredient.

To evaluate the utility of a steroid in the bladder instillation treatment of IC/BPS, we propose a randomized, double-blind, controlled trial that will compare the efficacy of bladder instillations with and without triamcinolone acetonide on IC/BPS symptoms in women. We hypothesize that the addition of triamcinolone acetonide in bladder instillation therapy will result in a more robust treatment response than bladder instillations without triamcinolone acetonide. Our rationale is based on 1) the results of small studies that showed improvement of IC/BPS symptoms with use of a steroid and 2) the hypothesized mechanism of action of steroids decreasing inflammation in the bladder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Syndrome

Intervention

Drug:
• Bladder instillation WITH triamcinolone acetonide
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 WITHOUT triamcinolone acetonide
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).

Locations

Country	Name	City	State
United States	University of Louisville Urogynecology at Springs Medical Center	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Olivia Cardenas-Trowers, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Bullones Rodríguez MÁ, 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. Review. — View Citation

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;(7):CD008943. doi: 10.1002/14651858.CD008943.pub2. Review. — View Citation

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. — View Citation

Clemens JQ, Meenan RT, Rosetti MC, Gao SY, Calhoun EA. Prevalence and incidence of interstitial cystitis in a managed care population. J Urol. 2005 Jan;173(1):98-102; discussion 102. — View Citation

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. — View Citation

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. Review. — View Citation

Dawson TE, Jamison J. Intravesical treatments for painful bladder syndrome/ interstitial cystitis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006113. Review. — View Citation

Nickel JC. Interstitial cystitis: a chronic pelvic pain syndrome. Med Clin North Am. 2004 Mar;88(2):467-81, xii. Review. — View Citation

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. Review. — View Citation

Soucy F, Grégoire M. Efficacy of prednisone for severe refractory ulcerative interstitial cystitis. J Urol. 2005 Mar;173(3):841-3; discussion 843. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pelvic Pain and Urgency/Frequency (PUF) Questionnaire	Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms)	Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Secondary	Overactive Bladder Questionnaire (OAB-q)	Total scores range: 0-100 (higher scores on the symptom-severity scale suggestive of greater severity of symptoms and higher scores on the quality-of-life scale suggestive of better quality of life)	Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Secondary	Pelvic Floor Distress Inventory (PFDI)	20 question self-administered questionnaire on the presence and absence of pelvic floor symptoms. Score ranges from 0 (least distress) to 300 (most distress).	Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Secondary	Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire	Measures sexual function in women with pelvic floor disorders. Queries about arousal, orgasm, partner-related issues, sexual quality, and desire. The tool also takes into account those who are not sexually active. The questionnaire was used in the study solely to determine if patients had improved dyspareunia (as a categorical variable).	Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Secondary	Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain	VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible)	Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Secondary	Number of Participants With at Least One Adverse Event	Adverse events will only be those determined to be related to the study drug	End of study (6 weeks)