A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis.
ABSTRACT We compared intravesical bacillus Calmette-Guerin (BCG) to placebo instillations in patients with treatment refractory interstitial cystitis (IC).
Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC, and reported at least moderate pain and frequency for a minimum of 6 months before study entry, were randomized to 6 weekly double-blinded intravesical instillations of either BCG or placebo, and then followed for a total of 34 weeks. The primary outcome was a patient reported global response assessment at week 34, supplemented with medications for IC during weeks 31 to 34. Secondary outcomes included a 24-hour voiding diary, pain, urgency, validated IC symptom indexes and adverse events. The target sample size was 260 participants, designed to detect a difference in response rates between placebo and BCG of 30% and 50%, respectively.
A total of 265 participants were randomized and 17 (6%) patients withdrew from study. The response rates for the primary outcome were 12% for placebo and 21% for BCG (p = 0.062). Small improvements were observed for all secondary outcomes, some more so with BCG, but these differences were of borderline statistical significance. Although a large number of adverse events were reported in the BCG arm, there was no statistically significant difference between the treatment arms in overall adverse event rates.
Although the BCG safety profile was acceptable, the response rate for the primary outcome was low. Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive.
SourceAvailable from: Seema A Tirlapur[Show abstract] [Hide abstract]
ABSTRACT: This paper investigates the quality of outcomes reported in systematic reviews and randomised controlled trials (RCTs) of bladder pain syndrome and its relationship with study quality and journal impact factor. We searched until August 2013 the Cochrane Library, EMBASE, Medline, CINAHL, LILACS and SIGLE, without language restrictions. Quality of outcome reporting in systematic reviews and constituent RCTs was assessed using a 6-point scale. Overall study quality was assessed using the AMSTAR and Jadad scoring systems, and impact factor in the year of publication was noted. Spearman rank correlation was calculated. There were eight systematic reviews, with a total of 28 RCTs (1732 patients), reporting 5 outcomes using 19 different measurement scales. The outcomes reported in individual RCTs were urinary symptoms (100%), pain [64%], quality of life [39%], general wellbeing [36%] and bladder capacity [36%]. The mean quality of outcomes reported was 1.63 (95% CI 0.29–2.96) for systematic reviews and 3.25 (95% CI 2.80 – 3.70) for RCTs. The quality of outcomes reported showed correlation with overall study quality (0.90, 95% CI 0.79 – 0.95, p < 0.0001) but not with journal impact factor (0.07, 95% CI -0.31–0.43, p = 0.35). Multivariable linear regression showed a relationship between quality of outcome reporting and study quality (β = 0.05, p < 0.0001), adjusting for effects of study type, impact factor and journal type. There is a need to generate consensus over a set of core outcomes in bladder pain syndrome using standardised reporting tools and to disseminate these through good publication practice.European Journal of Obstetrics & Gynecology and Reproductive Biology 09/2014; 180. DOI:10.1016/j.ejogrb.2014.06.003 · 1.63 Impact Factor
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ABSTRACT: : Urologic chronic pelvic pain syndrome (UCPPS) may be defined to include interstitial cystitis/bladder pain syndrome (IC/BPS) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The hallmark symptom of UCPPS is chronic pain in the pelvis, urogenital floor, or external genitalia often accompanied by lower urinary tract symptoms. Despite numerous past basic and clinical research studies there is no broadly identifiable organ-specific pathology or understanding of etiology or risk factors for UCPPS, and diagnosis relies primarily on patient reported symptoms. In addition, there are no generally effective therapies. Recent findings have, however, revealed associations between UCPPS and "centralized" chronic pain disorders, suggesting UCPPS may represent a local manifestation of more widespread pathology in some patients. Here, we describe a new and novel effort initiated by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the U.S. National Institutes of Health (NIH) to address the many long standing questions regarding UCPPS, the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. The MAPP Network approaches UCPPS in a systemic manner, in which the interplay between the genitourinary system and other physiological systems is emphasized. The network's study design expands beyond previous research, which has primarily focused on urologic organs and tissues, to utilize integrated approaches to define patient phenotypes, identify clinically-relevant subgroups, and better understand treated natural history and pathophysiology. Thus, the MAPP Network provides an unprecedented, multi-layered characterization of UCPPS. Knowledge gained is expected to provide important insights into underlying pathophysiology, a foundation for better segmenting patients for future clinical trials, and ultimately translation into improved clinical management. In addition, the MAPP Network's integrated multi-disciplinary research approach may serve as a model for studies of urologic and non-urologic disorders that have proven refractory to past basic and clinical study. Trial registration: ClinicalTrials.gov identifier: NCT01098279 "Chronic Pelvic Pain Study of Individuals with Diagnoses or Symptoms of Interstitial Cystitis and/or Chronic Prostatitis (MAPP-EP)"BMC Urology 08/2014; 14(1):57. DOI:10.1186/1471-2490-14-57 · 1.94 Impact Factor