An adaptive randomized clinical trial in interstitial cystitis/bladder pain syndrome evaluating efficacy of ASP3652 and the relationship between disease characteristics and Hunner’s lesions

Abstract IntroductionIn patients with interstitial cystitis or bladder pain syndrome (IC/BPS), 85% were found to have pelvic floor myofascial pain (PFMP) and hypertonicity (PFH). However, they are not typically trained to consider or assess PFMP as a contributing factor to patients’ IC/BPS symptoms. This study aimed to explore the relationship between PFMP and treatment outcomes in women with IC/BPS.MethodsPatients with IC/BPS who received any type of treatment were prospectively enrolled. They underwent vaginal digital examination at baseline. PFMP severity was quantified on the visual analog scale (VAS). Subject assessment items included O’Leary-Sant symptom score (OSS), Global Response Assessment (GRA), and Beck’s anxiety inventory. Object assessment items included bladder computed tomography (CT), urodynamic parameters, maximum bladder capacity, and grade of glomerulation.ResultsA total of 65 women with IC/BPS (mean age, 57.1 ± 11.3 years) were enrolled in the study. Patients with more severe PFMP had significantly higher rate of dyspareunia (p = .031); more comorbidities (p = .010); higher number of PFMP sites (p < .001); and higher OSS (p = .012). PFMP severity was not significantly correlated with bladder conditions, whether subjective or objective. Moreover, PFMP severity (VAS) was significantly negatively associated with GRA score.ConclusionPFMP might affect the subjective results of IC/BPS treatment but not the bladder condition. Therefore, in the future treatment of patients with IC/BPS, digital vaginal examinations of pelvic floor muscles should be performed and focused more on the PFM-related conditions, and necessary PFM treatments, such as the vaginal pelvic floor muscle message, should be scheduled.

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Treatment effectiveness in interstitial cystitis/bladder pain syndrome: Do patient perceptions align with efficacy-based guidelines?

Canadian Urological Association Journal ◽

10.5489/cuaj.4505 ◽

2017 ◽

Vol 12 (1) ◽

pp. E1-5 ◽

Cited By ~ 6

Author(s):

Avril Lusty ◽

Elizabeth Kavaler ◽

Kay Zakariasen ◽

Victoria Tolls ◽

J. Curtis Nickel

Keyword(s):

Clinical Trial ◽

Interstitial Cystitis ◽

Botulinum Toxin A ◽

Real Life ◽

Clinical Trial Data ◽

Pain Syndrome ◽

Bladder Pain Syndrome ◽

Trial Data ◽

Bladder Pain ◽

Perceived Outcomes

Introduction: We sought to determine if patients’ perceptions of success or failure of interstitial cystitis/bladder pain syndrome (IC/ BPS) therapies proposed in treatment guidelines align with the evidence from available clinical trial treatment data.Methods: A total of 1628 adult females with a self-reported diagnosis of IC completed a web-based survey in which patients described their perceived outcomes with the therapies they were exposed to. Previously published literature, used in part to develop IC/ BPS guidelines, provided the clinical trial data outcomes. Patientreported outcomes were compared to available clinical trial outcomes and published treatment guidelines.Results: Based on patient perceived outcomes (benefit:risk ratio), the most effective treatments were opioids, phenazopyridine, and alkalizing agents, with amitriptyline and antihistamines reported as moderately effective. The only surgical procedure with any effectiveness was electrocautery of Hunner’s lesions. In order of efficacy reported in the literature, the therapies for IC/BPS with predicted superior outcomes should be: cyclosporine A, amitriptyline, hyperbaric oxygen, pentosan polysulfate plus subcutaneous heparin, botulinum toxin A plus hydrodistension, and L-arginine. While some of the guideline recommendations aligned with patientreported effectiveness data, there was a general disconnect between guidelines and effectiveness reported in clinical practice.Conclusions: There is a disconnect between real-world patient perceived effectiveness of IC/BPS treatments compared to the efficacy reported from clinical trial data and subsequent guidelines developed from this efficacy data. Optimal therapy must include the best evidence from clinical research, but should also include real-life clinical practice implementation and effectiveness.

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